6-Minute Walk Test (6MWT or SMWT)

Instrument Name: 6-Minute Walk Test (6MWT or SMWT)

Abbreviation: 6-MWT or SMWT

Points for Consideration:

Not applicable to children with cognitive or endurance challenges who are unable to complete the COA even if they are physically able.

Description of Tool:

The 6MWT is a PerfO used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes.

Minimum Qualification Required by COA Administrator: MA or BA

Comment:

Walking tests have been used since the 1960s, with the first reported walking test being that of Balke (1963) 12-minute walk or run designed for the Federal Aviation Agency
Today they are used for a diverse range of illnesses (i.e. rheumatic conditions, heart conditions, respiratory conditions)
The following content will describe the 6-minute walking test (6-MWT; SMWT; 6MWT) as per the guidelines and information of the American Thoracic Society (published in 2002) and the American College of Rheumatology (reviewed in 2015)

Year: 2002

Objective of Development:

To measure response to medical interventions in patients with moderate to severe heart or lung disease
-To measure functional status of patients
-To serve as a predictor of morbidity and mortality

Population of Development: Age range (therapeutic indication):

All age ranges (All - Healthy and clinical populations)

Pediatric Population(s) in which COA has been used:

Nervous system diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Musculoskeletal Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Immune System Diseases; Female Urogenital Diseases and Pregnancy Complications; Wounds and injuries; Mental disorders; Neoplasms; Stomatognathic Diseases; Eye diseases; Digestive system diseases; OtorhiNolaryngologic Diseases; Male Urogenital Diseases; virus diseases; Endocrine diseases

COA type:

Number of Items 1

Mode of Administration:

Data Collection Mode:

Time for Completion: 6 minutes

Response Scales: Distance (meters)

Summary of Scoring:

Available Scores: Global score ranging from 0 to <1000m Weighting: No Score Interpretation: Shorter distance traveled = Worse health status

Evidence of Literature Review: Yes

Evidence of Instrument Review: Yes

Evidence of Clinical or Expert Input: Yes

Evidence of concept elicitation in target patient population: None identified

Evidence of a Saturation Grid: Not applicable

Evidence for Selection of Data Collection Method: None identified

Recall/Observation Period:

Evidence for Selection of Reponse Options: Not applicable

Evidence of cognitive interviewing of draft instrument in target patient population: None identified

Evidence of Preliminary Scoring of Items and Domains: Not applicable

Evidence related to respondent and administrator burden: None identified

Evidence of a Conceptual Framework: None identified

Evidence of an item-tracking matrix: Not applicable

Evidence related to item selection: Not applicable

Evidence of re-testing the final version: Not applicable

Internal consistency (Cronbach's alpha): Not applicable

Test-retest Reliability (ICC):

Cunha (2006)
- T-test: There was No difference between distances walked in
the two tests conducted under the same clinical conditions (p= 0.31)
- Was a definition of stability applied to identify stable patients: Yes; all clinical variables had returned to their basal values
- Time frame or interval between the two administrations: minimum 30 minutes
- Population/Disease: Patients with Cystic Fibrosis (mean age 11.0+1.9 years; age range 8-16 years); n= 16

Phillips (2019)
1- Pearson correlation coefficient: r= 0.95; p <0.0001 - Was a definition of stability applied to identify stable patients: No - Time frame or interval between the two administrations: ≥3 weeks - Population/Disease: Children (aged 6–12 y, mean age 8.9 (SD2.2) with pediatric hypophosphatasia (HPP); n= 11 2- Pearson correlation coefficient: r= 0.81; p= 0.125 - Was a definition of stability applied to identify stable patients: No - Time frame or interval between the two administrations: 7 weeks approx. - Population/Disease: Adolescents (13–17 y, mean age 15.8 (SD 0.9)with pediatric hypophosphatasia (HPP); n= 4 Dunaway S (2016) - Intraclass Correlation Coefficient (ICC): 0.992 95% Ci (0.979-0.997) - Was a definition of stability applied to identify stable patients: Yes, patients were considered stable during this interim period - Time frame or interval between the two administrations: 1 month - Population/Disease: Patients with SMA (n= 17; 10-49 years) Kempen JCE (2013) - Intraclass Correlation Coefficient (ICC): 0.92 95% Ci (0.81-0.97) - Was a definition of stability applied to identify stable patients: No - Time frame or interval between the two administrations: 7 days - Population/Disease: Patients with Duchenne muscular dystrophy, n=19 age 6 to 12.4 years Lopez de Uralde Villanueva I (2019) - Intraclass Correlation Coefficient (ICC): Children and adolescents: 0.861 (95% CI 0.754 to 0.924) Children: 0.874 (95% CI 0.708 to 0.948) Adolescents: 0.837 (95% CI 0.64 to 0.932) - Was a definition of stability applied to identify stable patients: No - Time frame or interval between the two administrations: 30 min - Population/Disease: Patients with cystic fibrosis, children n=20; aged 7-10 years and adolescent n= 20 aged 11-18 years McDonald CM (2013) - Intraclass Correlation Coefficient (ICC): 0.92 - Was a definition of stability applied to identify stable patients: No - Time frame or interval between the two administrations: 42 days - Population/Disease: Patients with DMD (n= 174 ; aged range: 5-20 years)

Inter-rater/ inter-interviewer reliability (kappa):

Not applicable

Evidence of test-retest or inter-rater reliability: Yes

Concurrent validity (convergent, divergent):

Montes (2009)
- Correlation coefficient used: Pearson correlation coefficient
- Measure: 10m walk/run
- Results: The 6MWT distance was significantly associated with the 10m walk/run time (r = -0.563, p= 0.036)
- Population/Disease: Patients with Spinal Muscular Atrophy (SMA) median age 11 years (range 4 - 47); n= 13

Lerario (2012)
- Correlation coefficient used: Pearson correlation coefficient; p< 0.001 for all results - Measure: Timed items in the North Star Ambulatory Assessment (NSAA): 10 m timed walk/run test and time to rise from the floor (Gower test) - Results: There were significant correlations between 6MWT results and 10m timed walk/run test results (r= -0.80) and Gower test results (r= -0.75) - Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (median age 8.5 years (range 5–12); n= 28 Holden (2010) - Correlation coefficient used: Not stated - Measure: Incremental Step Test (IST) - Results: There was a significant correlation between distance achieved in the 6MWT and the IST (r= 0.74, p= 0.006) - Population/Disease: Patients with cystic fibrosis (mean age 10.8 years, range 7-16 years); n= 12 Mazzone (2011) - Correlation coefficient used: Pearson correlation coefficient; p< 0.001 for all results - Measure: Timed items in the North Star Ambulatory Assessment (NSAA): 10 m timed walk/run test and time to rise from the floor (Gower test) - Results: There were significant correlations between the 6MWT and 10m timed walk/run (r= -0.59), 10m speed (r= -0.56) and Gower test (r= -0.45) - Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (mean age 8.3(SD 2.3), age range 4.1-17 years); n= 106 Phillips (2019) 1- Correlation coefficient used: Pearson correlation coefficient; p< 0.0001 for all results - Measure: CHAQ Disability Index (CHAQ-DI); PODCI Global Functioning Normative score; PODCI Transfers and Basic Mobility subscale Normative score, and Sports and Physical Functioning subscale Normative score; CHAQ Pain Interference (CHAQ-PI) and PODCI Pain/Comfort subscale Normative score - Results: - A negative linear relationship was found between distance walked and CHAQ-DI score (r= −0.67) - Positive linear relationships were found between distance walked and the following PODCI subscales: Global Function (r= 0.74), Transfers and Basic Mobility (r= 0.71) and Sports and Physical Functioning (r= 0.77) - The 6MWT also correlated with parent-reported measures of pain. Distance walked had a negative correlation with the CHAQ-PI (r= −0.39) and a positive correlation with the PODCI Pain/Comfort subscale (r= 0.45) - Population/Disease: Children (aged 6–12 y, mean age 8.9 (SD2.2) with pediatric hypophosphatasia (HPP); n= 11 2- Correlation coefficient used: Pearson correlation coefficient - Measure: Lower Extremity Functional Scale (LEFS) score; Brief Pain Inventory–Short Form (BPI-SF) severity and interference totals - Results: - Distance walked during the 6MWT had a positive linear relationship with LEFS score (r= 0.83; p< 0.00001) and negative linear relationships with the BPI-SF total pain severity score (r= −0.41; p= 0.0239) and total pain interference score (r= −0.41; p= 0.0252) - Population/Disease: Adolescents (13–17 y, mean age 15.8 (SD 0.9)with pediatric hypophosphatasia (HPP); n= 4 AlfaNo (2013) -Correlation coefficient used: Not stated - Measure: 2-min walk test (2MWT), and 100 m walk/run test (100 m) - Results: - The 2MWT and 100 m walk/run test were highly correlated with the 6MWT (r= 0.827 and r = 0.827 respectively, p= 0.002) - Population/Disease: Ambulatory subjects with Duchenne muscular dystrophy (DMD) (5-12 years old; mean = 9.6 +/- 2.1 years); n Not stated Henricson (2013) - Correlation coefficient used: Not stated - Measure: PedsQL total/physical function and PODCI global, transfer/mobility and sports/physical function - Results: p and exact data Not stated for all results - 6MWT distance was correlated with PODCI, with the transfer/mobility scale showing the strongest relationship (r= 0.79) - 6MWT distance weakly correlated with PedsQL - Population/Disease: Ambulatory subjects with Duchenne muscular dystrophy (DMD) (4-12 years old); n= 24 Wiklund (2012) - Correlation coefficient used: Not stated - Measure: Shortened Hunter Syndrome-Functional Outcomes for Clinical Understanding Scale (HS-FOCUS) (parent and self-reported version) - Results: The 6MWT was significantly correlated with the HS-FOCUS (> 0.30; p and exact data Not stated)
- Population/Disease: Subjects above 12 years old (n= 49) and parents of subjects with mucopolysaccharidosis II (MPS II, Hunter Syndrome) (n= 84)

Lowes (2012)
- Correlation coefficient used: Not stated
- Measure: Stair climbing; Berg Balance Scale (BBS); Quadriceps strength
- Results:
- In BMD the 6MWT was significantly correlated with stair climbing (r= -0.836) and the BBS (r= 0.853); p< 0.001 - In IBM the 6MWT was significantly correlated with stair climbing (r= -0.652) and quadriceps strength (r= 0.558); p< 0.001 - In DMD, all distances were moderately to highly correlated with other functional outcomes (r= 0.562-0.951, p< 0.01) - Population/Disease: 196 subjects (Duchenne Muscular Dystrophy (DMD) n= 85; Becker Muscular Dystrophy BMD n= 24; Inclusion Body Myositis (IBM) n= 87); age range Not stated Dunaway S (2016) 1. Correlation coefficient used: Pearson's correlation coefficient - Measure: Timed Up & Go Test (TUG) - Results: Significant correlation was found between 6MWD and TUG: r= -0.535; p= 0.033 - Population/Disease: Patients with SMA, n= 30; age included in the range 3.9 to 46 years 2.Correlation coefficient used: Pearson's correlation coefficient - Measure: 10 meter wall/run - Results: Significant correlation was found between 6MWD and the 10 meter walk/run: r= -0.937; p<0.001 - Population/Disease: Patients with SMA, n= 30; age included in the range 3.9 to 46 years 3. Correlation coefficient used: Pearson's correlation coefficient - Measure: Manual Muscle Testing (MMT) - Results: Significant correlation was found between 6MWD and the MMT total score: r=0.691; p<0.001 Significant correlation was found between 6MWD and MMT lower score: r= 0.676; p=0.002 - Population/Disease: Patients with SMA, n= 30; age included in the range 3.9 to 46 years 4. Correlation coefficient used: Pearson's correlation coefficient - Measure: hand-held dynamometry (HDD) - Results: Significant correlation was found between 6MWD and HHD knee flexor score: r= 0.622; p=0.004 - Population/Disease: Patients with SMA, n= 30; age included in the range 3.9 to 46 years McDonalds CM (2013) - Correlation coefficient used: Pearson's correlation coefficient - Measure: 10-m run/walk , 4-stair climb stairs, 4- stair descend, supine to stand - Results: p<0.0001 for all results Significant correlation was found between 6MWT and 10-m run/walk : r= 0.78 Significant correlation was found between 6MWT and 4-stair climb stairs: r= 0.77 Significant correlation was found between 6MWT and 4- stair descend: r= 0.73 Significant correlation was found between 6MWT and supine to stand : r= 0.73 - Population/Disease: Patients with DMD (n= 174 ; aged range: 5-20 years) Pane M (2014) - Correlation coefficient used: Spearman rank correlation coefficients - Measure: Performance of Upper Limb (PUL) test - Results: Correlation was found between 6MWD and the PUL: r= 0.499; p= Not stated - Population/Disease: Not stated Villa K (2017) - Correlation coefficient used: Not stated - Measure: Single two legged jump (S2LJ) and chair rising tests (CRT) - Results: Correlation was found between 6MWT and the S2LJ r= 0.64; p= Not stated Correlation was found between 6MWT and the CRT r= 0.52; p= Not stated - Population/Disease: Patients with Charcot-Marie-Tooth disease (n= 23, age 4.33-17.8 years, mean 11.7 years, median 13.1 years) Henricson F (2013) 1.Correlation coefficient used: Pearson's coefficient correlation - Measure: PedsQL Total Score and PedsQL Physical Function Score - Results: p: Not stated Correlation was found between 6MWT and the PedsQL Total Score r= 0.21 Correlation was found between 6MWT and the PedsQL Physical Function Score r= 0.18 - Population/Disease: Patients with DMD; n= 24 age ranged: 4-12 years 2. Correlation coefficient used: Pearson's coefficient correlation - Measure: PODCI Global Score, PODCI Transfer/Basic Mobility Score and PODCI Sports and Physical Function Score - Results: p: Not stated Correlation was found between 6MWT and the PODCI Global Score r= 0.68 Correlation was found between 6MWT and the PODCI Transfer/Basic Mobility Score r= 0.79 Correlation was found between 6MWT and the PODCI Sports and Physical Function Score r= 0.68 - Population/Disease: Patients with DMD; n= 24 age ranged: 4-12 years

Known-group validity:

Montes (2009)
- Measure/Groups of patients: Hammersmith Functional Motor Scale - Expanded (HFMSE)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson correlation coefficient. The 6MWT distance was significantly associated with the HFMSE score (r= 0.563, p= 0.028)
- Population/Disease: Patients with Spinal Muscular Atrophy (SMA) median age 11 years (range 4 - 47); n= 13

Lerario (2012)
- Measure/Groups of patients: Quantitative muscle strength assessed with the Kin Com® Robotic Dynamometer; North Star Ambulatory Assessment (NSAA )
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson correlation coefficient; p< 0.001 for all results - There were significant correlations between distance walked and Kin COM measures (r ranging from 0.59-0.72) - There was a significant correlation between distance walked and the NSAA (r= 0.80) - Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (median age 8.5 years (range 5–12); n= 28 Stollar (2012) - Measure/Groups of patients: Cystic Fibrosis severity markers (FEV1, BMI Z score, chest radiography (CXR) evaluated via Brasfield score, chest tomography (CT) evaluated via Bhalla score) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Spearman correlation. There were significant correlations between 6MWT Z scores and the FEV1 (rho= 0.59; p= 0.0002); BMI Z scores (rho= 0.42; p= 0.013), CXR (rho= 0.34; p= 0.0472) and CT (rho= -0.45; p= 0.0073) - Population/Disease: Patients with cystic fibrosis (6-21 years old; mean age 12.1+4 years); n= 34 Caboot (2010) - Measure/Groups of patients: According to age and height - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Spearman correlation coefficient. 6MWD was significantly correlated with age (r= 0.44; p< 0.005) and height (r= 0.44; p < 0.005) - Population/Disease: Asymptomatic children with sickle cell disease (SCD) (mean age 11 + 4 years, range 6 - 19 years); n= 44 Mazzone (2011) - Measure/Groups of patients: North Star Ambulatory Assessment (NSAA) - Results: Pearson correlation coefficient. There was a significant correlation between the 6MWT and the NSAA (r= 0.68; p< 0.001) - Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (mean age 8.3(SD 2.3), age range 4.1-17 years); n= 106 Cunha (2006) - Measure/Groups of patients: Maximal expiratory pressure (PEmax); Maximal Heart Rage (HRmax); Double product (Heart Rate (HR)x Arterial Blood Pressure (ABP)); Dyspnea as measured by the modified Borg Dyspnea Scale - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Pearson correlation coefficient. There were significantly correlations between distance walked and PEmax (r= 0.60; p= 0.01), HRmax (r= 0.59; p= 0.02), Dyspnea (r= 0.55; p= 0.03) and Double product (r= 0.59; p= 0.02) - Population/Disease: Patients with Cystic Fibrosis (mean age 11.0+1.9 years; age range 8-16 years); n= 16 Zaidman CM (2015) - Measure/Groups of patients: Correlation with the Electrical Impedance Myography - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Correlation between Electrical Impedance Myography and 6MWT was significant (p<0.006). Results were: r= 0.55 to 0.58. - Population/Disease: Patients with Duchenne Muscular Dystrophy ; n= 61, aged 3-12 years Pektas (2016) KNown-groups validity - Measure/Groups of patients: Difference in 6MWD in groups of patients classified by their Functional Class: Class 1, n= 2 ; Class 2, n= 18; Class 3, n= 17 and Class 4, n= 3 and correlation with biomarkers: BNP, CA-125 and vWF levels - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: tests used: Not stated Significant difference in 6MWD (p<0.001) was found between Class 4 (120.0m +/- 14.1 m) and Class 1 (460 +/-0.0) Significant correlation (coefficient used: Not stated) were found between 6MWD and BNP (p= 0.008), CA-125 (p= 0.016) and vWF levels (p= 0.019) - Population/Disease: Children with pulmonary hypertension, n= 40 age: Not stated Dunaway S (2016) - Measure/Groups of patients: Difference in disease severity between patient with SMA types 3a and 3b - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Significant difference in 6MWT was found according patients disease severity with SMA types 3a and 3b: F= 5.707, p=0.024 - Population/Disease: Patients with SMA type 3a or 3b, n= 30, mean age: 23.7 years, (3.9 to 49 years) Fidler LM (2019) . Measure/Groups of patients: Difference in 6MWT between patients with systemic lupus erythematosus (SLE)and with pulmonary disease (n= 89) or without (n= 21) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: tests used: Not stated The presence of ay pulmonary disease was associated with a reduction in 6MWT distances (p>0.001)
- Population/Disease: Patients with systemic lupus erythematosus (SLE)and with pulmonary disease (n= 89) or without (n= 21), age: Not stated

Okama LO (2017)
. Measure/Groups of patients: North Star Ambulatory Assessment (NSAA)
- A priori hypotheses: Correlation would be find
- Were hypotheses confirmed: Yes
- Results: Spearman's coefficient correlation
Significant correlation was found between 6MWT and NSAA; r= 0.433; p= 0.0027
- Population/Disease: Infants and Children with (n= 35)or without DMD n= 73 age: 4-15 years for DMD sample and 5-13 control sample

McAlister (2016)
. Measure/Groups of patients: Radiographic Global Impression of Change (RGI-C)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: Pearson's coefficient correlation
Significant correlation was found between RGI-C and 6MWT r= 0.284; p= 0.0043
- Population/Disease: Patients with hypophosphatasia, n: Not stated, age : patients were < or > 5 years in this study

Bozgeyik S (2015)
- Measure/Groups of patients: Difference in distance assessed by the 6MWT between groups of DMD children (n= 40) and control groups (n= 40)
- A priori hypotheses: Not stated
- Were hypotheses confirmed: Not applicable
- Results: test used, Not stated; data Not shown
Distance was significantly higher in the control group (p<0.001) than the DMD group - Population/Disease: Patients with or without DMD; n= 80 age: Not stated Phillips D (2018) - Measure/Groups of patients: Correlation with the modified Performance-Oriented Mobility Assessment Gait Subtest (mPOMA-G) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Pearson's correlation coefficient, all results p<0.0002 Significant correlation was found between 6MWT and mPOMA-G in infantile hypophosphatasia, r= 0.83 Significant correlation was found between 6MWT and mPOMA-G in childhood hypophosphatasia, r= 0.70 - Population/Disease: Patients with hypophosphatasia, n= 64 age range: 5-15 years Lollert A (2018) 1. Measure/Groups of patients: Correlation with psoas muscle Fat Fraction L3 (FF L3) and Fat Fraction L5 (FF L5) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Sperman's correlation coefficient (rho) Significant correlation was found between 6MWT and FF L3, rho= -0.42 Significant correlation was found between 6MWT and FF L5, rho= -0.48 - Population/Disease: Patients with late onset Pompe Disease, n= 41 ge range: 6-74 years 2. Measure/Groups of patients: Correlation with paraspinal muscles muscle Fat Fraction L3 (FF L3) and Fat Fraction L5 (FF L5) - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Sperman's correlation coefficient (rho) Significant correlation was found between 6MWT and FF L3, rho= -0.52 Significant correlation was found between 6MWT and FF L5, rho= -0.52 - Population/Disease: Patients with late onset Pompe Disease, n= 41 ge range: 6-74 years 3. Measure/Groups of patients: Correlation with Mercuri score for psoas muscle and paraspinal muscles - A priori hypotheses: Not stated - Were hypotheses confirmed: Not applicable - Results: Sperman's correlation coefficient (rho) Significant correlation was found between 6MWT and Mercuri score for psoas muscle, rho= -0.4 Significant correlation was found between 6MWT and Mercuri score for paraspinal muscles rho= -0.4 - Population/Disease: Patients with late onset Pompe Disease, n= 41 ge range: 6-74 years

Evidence of Translatability Assessment: None identified

Evidence related to missing data: None identified

Evidence for Selection of Recall Period: Not applicable

Evidence of Administration Instructions and Training Provided: Yes

Evidence of concurrent validity: Yes

Evidence of known-groups validity: Yes

Evidence of ability to detect change over time: Yes

Ability to detect change (Responsiveness):

Lerario (2012)
Methods:
- Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (median age 8.5 years (range 5–12); n= 28
- Time horizon: 12 months (expressed as a 3-monthly slope)
- Measure: Change in quantitative muscle strength assessed with the Kin Com® Robotic Dynamometer
- Statistics used: Spearman rank correlation
- Results:
- The 3 monthly change of the isometric Knee Flexion correlated with the change of the 6MWT (rho= 0.50, p= 0.01)
- The 3 monthly change of the isokinetic Knee Flexion correlated with the change of the 6MTW (rho= 0.51, p= 0.01)

Mazzone (2011)
Methods:
- Population/Disease: Boys with Duchenne muscular dystrophy (DMD) (mean age 8.3(SD 2.3), age range 4.1-17 years); n= 106
- Time horizon: 12 months
- Measure: Change as measured by the North Star Ambulatory Assessment (NSAA) and it's timed items (10 m timed walk/run test and time to rise from the floor (Gower test)); Age
- Statistics used: Pearson correlation coefficient
- Results:
- Change over 12 months in the 6MWT correlated significantly with change in the NSAA (r= 0.52), the 10m timed walk/run test (r= -0.51), 10m speed (r= 0.36) and the Gowers test (r= -0.48); p< 0.001 for all results - Change over 12 months in the 6MWT was significantly correlated with age (p= 0.001) - Magnitude of change: - Total (n= 106): -25.8 (SD 74.3) - Patients < 7 years of age (n= 35): -7.8 (SD 63.9) - Patients > 7 years of age (n= 71): -42.3 (SD 73.9)

Phillips (2019)
Methods:
- Population/Disease: Children (aged 6–12 y, mean age 8.9 (SD2.2) with pediatric hypophosphatasia (HPP); n= 11
- Time horizon: ≥3 weeks
- Measure: Change as measured by the Radiographic Global Impression of Change (RGI-C) scale and Rickets Severity Scale (RSS)
- Statistics used: Pearson correlation coefficient
- Results:
- There was a positive linear relationship between the change from Baseline in 6MWT distance walked and improvement in RGI-C score (r= 0.50; p< 0.0001) and a negative linear relationship between distance walked and RSS score (r= −0.78; p< 0.0001, such that distance walked increased as the severity of skeletal disease decreased. Henricson (2013) Methods: - Population/Disease: Ambulatory subjects with Duchenne muscular dystrophy (DMD) (4-12 years old); n= 24 - Time horizon: 1 year - Measure: Change in PODCI global and PODCI transfer/mobility scores - Statistics used: Not stated - Results: p Not stated - 6MWT change highly correlated with change in PODCI global and PODCI transfer/mobility scores (r = 0.76 and r = 0.93) - Magnitude of change: - A “meaningful” 4.5 point change in a low PODCI transfer/mobility score of 30–34.5 was associated with a 5.6 m 6MWT change from 150.3 to 155.9 m - At PODCI levels closer to Normative levels changes in 6MWT distance needed to affect a “meaningful” change in PODCI scores were associated with a 6MWT change of almost 46 m

Responder Thresholds:

Phillips (2019)
- The estimated MCID for the 6MWT in adolescents with HPP was 43.0 m using the Standard Error of Measurement (SEM) method and 32.9 m using the one third Standard Deviation (SD) method
- The MCID for the 6MWT in children with HPP was estimated at 20.6 m using the SEM method and 30.8 m using the SD method
Population/Disease: Children (aged 6–12 y, mean age 8.9 (SD2.2) with pediatric hypophosphatasia (HPP); n= 11 and Adolescents (13–17 y, mean age 15.8 (SD 0.9)with pediatric hypophosphatasia (HPP); n= 4

Kempen JCE (2013)
Methods: From the SEM
Patients: Patients with Duchenne muscular dystrophy, n=19 age 6 to 12.4 years
Results:
From the SEM (= 18.4 (4.4)) the smallest detectable change was calculated. Result was = 51 (12.2)

Lopez de Uralde Villanueva I (2019)
Methods: From the SEM
Patients: Patients with cystic fibrosis, children n=20; aged 7-10 years and adolescent n= 20 aged 11-18 years
Results:
Children and adolescents:SEM= 22.92; MDC90 = 53.49 (8%) ; MDC95 = 63.54 (10%)
Children: SEM= 25.45; MDC90 = 53.39 (9%) ; MDC95 = 70.55 (11%)
Adolescents: SEM= 20.49; MDC90 = 47.81 (7%) ; MDC95 = 56.8 (9%)

McDonald CM (2013)
Methods:
1.Distribution based From the SEM define as: baseline SD* rac(1-r) where r is test-retest reliability
2.Distribution based From the SEM define as: 1/3baseline SD* rac(1-r) where r is test-retest reliability
Patients: Patients with DMD (n= 174 ; aged range: 5-20 years)
Results:
1. MCID = 28.5
2. MCID = 31.7

Evidence of responder thresholds: Yes

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[Conference Abstract] Montes J, Dunaway S, Glanzman A. The 6-minute walk test in ambulatory subjects with SMA. Journal of Clinical Neuromuscular Disease. Conference: 31st Annual Carrell- Krusen Symposium. Dallas, TX United States. Conference Publication: (var.pagings). 10 (3) (pp 156), 2009. Date of Publication: March 2009

Lerario A, Bonfiglio S, Sormani M, Tettamanti A, Marktel S, NapolitaNo S, Previtali S, Scarlato M, Natali-Sora M, Mercuri E, Bresolin N, Mongini T, Comi G, Gatti R, Ciceri F, Cossu G, Torrente Y. Quantitative muscle strength assessment in Duchenne muscular dystrophy: longitudinal study and correlation with functional measures. BMC Neurol. 2012 Sep 13;12:91
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Stollar F, Rodrigues JC, Cunha MT, Leone C, Adde FV. Six minute walk test Z score: correlations with cystic fibrosis severity markers. J Cyst Fibros. 2012 May;11(3):253-6. doi: 10.1016/j.jcf.2011.11.009
Full Text Article: https://www.sciencedirect.com/science/article/pii/S1569199311002153?via%3Dihub

[Conference Abstract] Holden HJ, Mockett S, Smyth AR.The development and validation of the incremental step test (IST) in children with cystic fibrosis (CF).Journal of Cystic Fibrosis. Conference: 33rd European Cystic Fibrosis Conference. Valencia Spain. Conference Publication: (var.pagings). 9 (SUPPL. 1) (pp S69), 2010. Date of Publication: June 2010

[Conference Abstract] Caboot JB, Jawad AF, Bowdre CY. The six-minute walk test in children with sickle cell disease. American Journal of Respiratory and Critical Care Medicine. Conference: American Thoracic Society International Conference, ATS 2010. New Orleans, LA United States. Conference Publication: (var.pagings). 181 (1 Meeting Abstracts) (No pagination), 2010. Date of Publication: 01 May 2010

Mazzone E, Vasco G, Sormani MP, Torrente Y, Berardinelli A, Messina S, D'Amico A, Doglio L, PolitaNo L, Cavallaro F, Frosini S, Bello L, Bonfiglio S, Zucchini E, De Sanctis R, Scutifero M, Bianco F, Rossi F, Motta MC, Sacco A, Donati MA, Mongini T, Pini A, Battini R, Pegoraro E, Pane M, Gasperini S, Previtali S, NapolitaNo S, Martinelli D, BruNo C, Vita G, Comi G, Bertini E, Mercuri E. Functional changes in Duchenne muscular dystrophy: a 12-month longitudinal cohort study. Neurology. 2011 Jul 19;77(3):250-6
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Cunha MT, Rozov T, de Oliveira RC, Jardim JR. Six-minute walk test in children and adolescents with cystic fibrosis. Pediatr PulmoNol. 2006 Jul;41(7):618-22
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Phillips D, Tomazos IC, Moseley S, L'Italien G, Gomes da Silva H, Lerma Lara S. Reliability and Validity of the 6-Minute Walk Test in Hypophosphatasia. JBMR Plus. 2019 Mar 1;3(6):e10131
Full Text Article: https://asbmr.onlinelibrary.wiley.com/doi/full/10.1002/jbm4.10131

[Conference Abstract] AlfaNo LN, Lowes LP, Flanigan KM.A shorter timed walking or running test may be sufficient for testing function in Duchenne muscular dystrophy. Neuromuscular Disorders. Conference: 18th International Congress of The World Muscle Society. Pacific Grove, CA United States. Conference Publication: (var.pagings). 23 (9-10) (pp 751-752), 2013. Date of Publication: October 2013. [Conference Abstract: https://www.sciencedirect.com/science/article/abs/pii/S0960896613005890]

[Conference Abstract] Henricson EK, Abresch RT, Han JJ. Comparison of 6MWD and person-reported functional measures in boys with Duchenne muscular dystrophy aged 4-12 years. Neuromuscular Disorders. Conference: 18th International Congress of The World Muscle Society. Pacific Grove, CA United States. Conference Publication: (var.pagings). 23 (9-10) (pp 750), 2013. Date of Publication: October 2013 [Conference Abstract: https://www.sciencedirect.com/science/article/abs/pii/S0960896613005853]

Wiklund I, Raluy M, Chen WH.Item reduction and assessment of measurement properties of the hunter syndrome - Functional outcomes for clinical understanding scale (HS-FOCUS). Value in Health. Conference: ISPOR 15th Annual European Congress. Berlin Germany. Conference Publication: (var.pagings). 15 (7) (pp A514), 2012. Date of Publication: November 2012 [Conference Abstract: https://www.valueinhealthjournal.com/article/S1098-3015(12)03469-9/fulltext]

[Conference Abstract] Lowes L, AlfaNo L, Viollet L.Moderate walking distances and velocity correlate with function comparable to 6 minute walk test.Neurology. Conference: 64th American Academy of Neurology Annual Meeting. New Orleans, LA United States. Conference Publication: (var.pagings). 78 (1 Meeting Abstract) (No pagination), 2012. Date of Publication: 22 Apr 2012 [Conference Abstract: https://n.neurology.org/content/78/1_Supplement/S49.005]

McDonald CM, Henricson EK, Abresch RT, Florence J, Eagle M, Gappmaier E, Glanzman AM; PTC124-GD-007-DMD Study Group, Spiegel R, Barth J, Elfring G, Reha A, Peltz SW. The 6-minute walk test and other clinical endpoints in Duchenne muscular dystrophy: reliability, concurrent validity, and minimal clinically important differences from a multicenter study. Muscle Nerve. 2013 Sep;48(3):357-68
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Zaidman CM, Wang LL, ConNolly AM, Florence J, Wong BL, Parsons JA, Apkon S, Goyal N, Williams E, Escolar D, Rutkove SB, Bohorquez JL; DART-EIM Clinical Evaluators Consortium. Electrical impedance myography in Duchenne muscular dystrophy and healthy controls: A multicenter study of reliability and validity. Muscle Nerve. 2015 Oct;52(4):592-7.
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[Conference Abstract] Pektas A, Kula S, Oguz D. The efficacy and reliability of biological markers in pediatric pulmonary hypertension. 48th Annual Meeting of the Association for European Paediatric and Congenital Cardiology, with joint sessions with the Japanese Society of Pediatric Cardiology and Cardiac Surgery and Asia-Pacific Cardiac Society, Helsinki, Finland.

[Conference Abstract] Fidler LM, Keen K, Touma Z. Effects of Pulmonary Disease on Quality of Life Measures in Systemic Lupus Erymathosus.
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Okama LO, Zampieri LM, Ramos CL, Toledo FO, Alves CRJ, Mattiello-Sverzut AC, Mayhew A, Sobreira CFR. Reliability and validity analyses of the North Star Ambulatory Assessment in Brazilian Portuguese. Neuromuscul Disord. 2017 Aug;27(8):723-729.
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Vill K, Ille L, Blaschek A, Rawer R, Landgraf MN, Gerstl L, Schroeder SA, Müller-Felber W. Jumping MechaNography as a Complementary Testing Tool for Motor Function in Children with Hereditary Motor and Sensory Neuropathy. Neuropediatrics. 2017 Dec;48(6):420-425.
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Lollert A, Stihl C, Hötker AM, Mengel E, König J, Laudemann K, Gökce S, Düber C, Staatz G. Quantification of intramuscular fat in patients with late-onset Pompe disease by conventional magnetic resonance imaging for the long-term follow-up of enzyme replacement therapy. PLoS One. 2018 Jan 9;13(1):e0190784.
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Pane M, Mazzone ES, Sivo S, Fanelli L, De Sanctis R, D'Amico A, Messina S, Battini R, Bianco F, Scutifero M, Petillo R, Frosini S, Scalise R, Vita GL, BruNo C, Pedemonte M, Mongini T, Pegoraro E, Brustia F, Gardani A, Berardinelli A, Lanzillotta V, ViggiaNo E, Cavallaro F, Sframeli M, Bello L, Barp A, Busato F, Bonfiglio S, Rolle E, Colia G, Bonetti A, Palermo C, GraziaNo A, D'Angelo G, Pini A, Corlatti A, Gorni K, Baranello G, Antonaci L, Bertini E, PolitaNo L, Mercuri E. The 6 minute walk test and performance of upper limb in ambulant Duchenne muscular dystrophy boys. PLoS Curr. 2014 Oct 7;6:ecurrents.md.a93d9904d57dcb08936f2ea89bca6fe6.
Full Text Article: https://pubmed.ncbi.nlm.nih.gov/25642376/

[Conference Abstract] McAlister W. Validation of a Novel scoring system, the radiographic global impression of change (RGI-C) scale, for assessing skeletal manifestations of hypophosphatasia in infants and children. Pediatric Radiology. Conference: 7th International Pediatric Radiology Conjoint Meeting and Exhibition. Chicago, IL United States. Conference Publication: (var.pagings). 46 (SUPPL. 1) (pp S304), 2016. Date of Publication: May 2016.

[Conference Abstract] Dunaway S. Six-minute walk test is reliable and valid in spinal muscular atrophy. Neurology. Conference: 67th American Academy of Neurology Annual Meeting, AAN 2015. Washington, DC United States. Conference Publication: (var.pagings). 84 (SUPPL. 14) (No pagination), 2015. Date of Publication: 06 Apr 2015.

[Conference Abstract] Bozgeyik S, Karaduman A.A. Effects of head and neck muscle strength on functional independence level in boys with Duchenne muscular dystrophy. Fizyoterapi Rehabilitasyon. Conference: 3. Pediatrik Rehabilitasyon Kongresi. Ankara Turkey. 26 (3) (pp P41-P42), 2015. Date of Publication: 2015.

Yes

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Original: English

Translations:
Japanese for Japan
French for France

None identified

Authors:
American Thoracic Society

Contact:
American Thoracic Society
Diane Gern
Chief, Journals
American Thoracic Society
25 Broadway, 18th Floor
New York, NY 10004
Phone: 212-315-6441
E-mail: dgern@thoracic.org

European Respiratory Society
Valerie Vaccaro
E-mail: valerie.vaccaro@ersnet.org

Copyright:
None identified

CoU:
please contact directly Diane Gern. The updated standards (Holland et al. 2014) was jointly developed by the ATS and ERS, and the ERS published it in the ERJ, so permission from the ERS needs to be obtained from the ERS to use the ERS Guidelines. In which case, please contact Valerie Vaccaro.

American College of Rheumatology Website: https://www.rheumatology.org/I-Am-A/Rheumatologist/Research/Clinician-Researchers/Six-Minute-Walk-Test-SMWT

European Respiratory Journal Website: https://erj.ersjournals.com/

None identified