Peripheral Artery DiseaseLITENCT02538900

Low InTensity Exercise Intervention in PAD

A study testing Exercise in people with Peripheral Artery Disease, run by Northwestern University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease
What is being tested?: Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 305 participants
Where: 4 sitesUnited States
Study dates: Jun 2015to 19 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All participants will have PAD. PAD will be defined as follows. First, an ABI < or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of >0.90 and < or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.

Who cannot join

Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
Individuals whose walking is limited by a condition other than PAD.
> Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.
Mini-mental status examination score <23, dementia, or psychiatric illness including severe depression or anxiety. Investigator discretion may be used to allow some people with an MMSE below 23 to participate if the investigator determines there is another reason for their lower score, including lack of sufficient familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher.

Show all 10Show fewer

Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention.
Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention. For a clinical trial involving open-label therapy in which the treatment is not related to functional performance and will not change during the LITE Trial, participants may still qualify for the LITE Trial based on investigator discretion.
Individuals with PAD who have a history of lower extremity revascularization and have a normal ABI.
Individuals who are not able to walk for exercise at a sufficiently slow pace to avoid ischemic leg symptoms.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Northwestern University
Chicago, Illinois, 60611
University of Minnesota
Minneapolis, Minnesota, 55455
Ochsner Baptist, Tulane University
New Orleans, Louisiana, 70121
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.

Read the detailed description

We will randomize 305 PAD participants to one of three parallel arms: Group 1: Low-intensity, self-paced walking exercise; Group 2: Standard high intensity, ischemic pain-inducing walking exercise; Group 3: Non-exercising attention control group. The low and high intensity exercise groups will attend center-based exercise sessions once per week for four weeks followed by transition to an entirely home-based exercise program for an additional 48 weeks (52 weeks total). Coaches will contact participants weekly by telephone after the first four weeks of the intervention. The low and high intensity exercise interventions will use identical self-regulatory and support strategies. However, the low intensity exercise group will be instructed to exercise with minimal to no ischemic leg discomfort and the high intensity group will be instructed to exercise to maximal ischemic leg pain. These two distinct exercise prescriptions will be reinforced during 48 weeks of home-based exercise, using a well-validated behavioral coaching model that can be delivered by telephone once weekly. Our primary outcome is change in six-minute walk distance at 52-week follow-up. If our hypotheses are correct, millions of people with PAD will benefit from this alternative exercise regimen which will be accessible to most of the 8 million people in the U.S. who suffer from PAD.

Conditions: Peripheral Artery Disease
Being tested: Exercise, Attention control
Keywords: peripheral arterial disease, peripheral artery disease, PAD, exercise
Medical subject headings: Peripheral Arterial Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseBehavioural
Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
Attention controlOther
Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.

Study groups in NCT02538900
Study group	Role	What they receive
Group 1	Experimental	Low-intensity, self-paced walking exercise. Home based exercise. Receives: Behavioral: Exercise
Group 2	Experimental	Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise. Receives: Behavioral: Exercise
Group 3	Active comparator	Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. Receives: Other: Attention control

What is being measured

The primary outcome is the main question the study is designed to answer.

Six-minute Walk Distance
In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.
Measured: change from baseline to week 52

Secondary outcomes (7)

Six-minute Walk Distance
In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.
Measured: change from baseline to week 26
Maximal Treadmill Walking Time
In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Time walked is recorded
Measured: change from baseline to week 52
Physical Activity Levels
ActiGraph measured physical activity
Measured: Change from baseline to week 52
Walking Impairment Questionnaire (WIQ) Distance and Speed Score.
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.
Measured: change from baseline to week 52
Health-related Quality of Life Measure
The SF-36 physical functioning score will be used to measure quality of life.
Measured: change from baseline to week 52
Adherence to Intervention
Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.
Measured: from baseline to week 52
Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress.
Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress.
Measured: change from baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201519 Oct 2020

First posted2 Sep 2015 (estimated)
Study startJun 2015
Primary completion19 Oct 2020
Study completion19 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02538900
Sponsor's protocol ID: STU00105855
Other IDs: 1R01HL122846-01
Acronym: LITE
Status last verified: Oct 2021
First submitted: 31 Aug 2015
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974
Whipple MO, Xu S, Zhang D, Guralnik JM, Spring B, Tian L, Treat-Jacobson D, Zhao L, Criqui MH, McDermott MM. Home-Based Exercise and Patient-Reported Outcome Measures in Peripheral Artery Disease: The LITE Randomized Clinical Trial. Am J Cardiol. 2025 Jun 1;244:41-47. doi: 10.1016/j.amjcard.2025.02.027. Epub 2025 Feb 26.
PubMed 40020770
Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27.
PubMed 35894088
Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8.
PubMed 33829920
McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.
PubMed 33821898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low InTensity Exercise Intervention in PAD
ClinicalTrials.gov ID: NCT02538900
Acronym / sponsor ID: LITE / STU00105855
Conditions: Peripheral Artery Disease
Keywords: peripheral arterial disease, peripheral artery disease, PAD, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jun 2015
Primary completion: 19 Oct 2020 (actual)
Study completion: 19 Oct 2020 (actual)
First posted: 2 Sep 2015 (estimated)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Behavioral: ExerciseLow-intensity, self-paced walking exercise. Home based exercise.
Group 2	Experimental	Behavioral: ExerciseStandard high intensity, ischemic pain-inducing walking exercise. Home based exercise.
Group 3	Active comparator	Other: Attention controlNon-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All participants will have PAD. PAD will be defined as follows. First, an ABI < or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of >0.90 and < or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.

Key exclusion criteria (10 listed)

Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
Individuals whose walking is limited by a condition other than PAD.
> Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExerciseParticipants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.	Behavioural	Group 1, Group 2
Attention controlOur attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.	Other	Group 3

Primary outcome

Six-minute Walk Distance
Time frame: change from baseline to week 52
In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.

7 secondary outcomes

Six-minute Walk Distance
Time frame: change from baseline to week 26
Maximal Treadmill Walking Time
Time frame: change from baseline to week 52
Physical Activity Levels
Time frame: Change from baseline to week 52
Walking Impairment Questionnaire (WIQ) Distance and Speed Score.
Time frame: change from baseline to week 52
Health-related Quality of Life Measure
Time frame: change from baseline to week 52
Adherence to Intervention
Time frame: from baseline to week 52
Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress.
Time frame: change from baseline to week 52

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	116	96
Group 2	124	106
Group 3	65	48

Primary outcome: Six-minute Walk Distance

Time frame: change from baseline to week 52. Least squares mean (95% Confidence Interval). Unit: meters

Measure	Group 1 n = 116	Group 2 n = 124	Group 3 n = 65
Value	-6.4 (-21.5 to 8.8)	34.5 (20.1 to 48.9)	-15.1 (-35.8 to 5.7)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected monthly through out the 12-month intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	43 of 116 (37.1%)	34 of 116 (29.3%)	2 of 116
Group 2	40 of 124 (32.3%)	42 of 124 (33.9%)	2 of 124
Group 3	19 of 65 (29.2%)	29 of 65 (44.6%)	2 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42035974McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
Derived from this study: PubMed 40020770Whipple MO, Xu S, Zhang D, Guralnik JM, Spring B, Tian L, Treat-Jacobson D, Zhao L, Criqui MH, McDermott MM. Home-Based Exercise and Patient-Reported Outcome Measures in Peripheral Artery Disease: The LITE Randomized Clinical Trial. Am J Cardiol. 2025 Jun 1;244:41-47. doi: 10.1016/j.amjcard.2025.02.027. Epub 2025 Feb 26.
Derived from this study: PubMed 35894088Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27.
Derived from this study: PubMed 33829920Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8.
Derived from this study: PubMed 33821898McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.
Individual participant dataSharing planned: Undecided

Related trials for Peripheral Artery Disease

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary McDermott, MD principal investigator

Northwestern University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Peripheral Artery Disease, run by Northwestern University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute Walk Distance (time frame: change from baseline to week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02538900, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.