Peripheral Artery DiseaseGAITNCT02075502
Community Walking Exercise for Patients With Peripheral Artery Disease
A study testing Exercise therapy, lower extremity ET and peripheral open intervention in people with Peripheral Artery Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Exercise therapy, lower extremity ET and peripheral open intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women diagnosed with atherosclerotic PAD
- ≥40 years of age
- An abnormal ankle-brachial index (ABI) of ≤.90
- For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
- Patients receiving lower extremity ET or peripheral open intervention
- Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI
Who cannot join
- Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill
- Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
- PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
- Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
- Individuals who are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute
Show all 24Show fewer
- Individuals who have had a myocardial infarction within 3 months prior to screening
- Individuals who demonstrate symptoms consistent with acute coronary syndrome
- Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ≥0.5 mm at rest and >1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ≥1 mm)
- Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
- Individuals with left bundle branch block or sustained ventricular tachycardia (>30 sec) during screening
- Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
- Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening; Patients can be reconsidered for study inclusion following a 1 month washout period from these medications
- Electrolyte abnormalities (e.g., potassium <3.3 mmol∙Lˉ1 )
- Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening)
- Incarcerated individuals
- Individuals acutely impaired by alcohol or other illicit drugs
- Poorly controlled diabetes defined as glycated hemoglobin >12%
- Severely anemic patients (Hgb <11 g∙dLˉ1 for women and <10 g∙dLˉ1 for men)
- For patients who have not received peripheral revascularization, an ABI of >0.90
- For patients with equivocal resting ABIs (0.91-0.99), a drop of <15% in the post-exercise ABI
- For individuals with non-compressible vessels (ABI >1.39) who have a toe- brachial index (TBI) >0.70
- Inability to speak English
- Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
International Heart Institute of Montana Foundation
Missoula, Montana, 59802
About this study
Official title: A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease
The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
Read the detailed description
The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.
- Conditions
- Peripheral Artery Disease
- Being tested
- Exercise therapy, lower extremity ET, peripheral open intervention
- Keywords
- claudication, community walking exercise, community-based participatory research, exercise adherence, endovascular therapy
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyBehavioural
The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).
lower extremity ETProcedure or surgery
catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
peripheral open interventionProcedure or surgery
revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Experimental | Claudication, no peripheral revasc Receives: Behavioral: Exercise therapy |
| Exercise advice | Placebo comparator | Claudication, no peripheral revasc Receives: Behavioral: Exercise therapy |
| lower extremity ET, exercise therapy | Experimental | Not described Receives: Behavioral: Exercise therapy; Procedure: lower extremity ET |
| lower extremity ET, exercise advice | Placebo comparator | Not described Receives: Procedure: lower extremity ET |
| Peripheral open intervention, exercise therapy | Experimental | Not described Receives: Behavioral: Exercise therapy; Procedure: peripheral open intervention |
| Peripheral open intervention, exercise advice | Placebo comparator | Not described Receives: Procedure: peripheral open intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak walking time (PWT)
Measured: Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period
Secondary outcomes (6)
Change in claudication onset time (COT)
Measured: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in patient-reported outcomes
Measured: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in peak oxygen uptake
Measured: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in functional ability
Functional ability will be assessed with the 6-min walk test and Short Physical Performance Battery which consists of 1) walking short distances, 2) completing balance tests and 3) sit and standing from a chair 5 times.
Measured: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Evaluation of total volume of activity
Measured: post-12 weeks (exercise and control groups)
Evaluation of exercise adherence
For patients randomized to the exercise therapy group
Measured: post-12 weeks (exercise and control groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start1 Feb 2014
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ryan J. Mays, PhD, MPH, MS, Principal investigator, International Heart Institute of Montana Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075502
- Sponsor's protocol ID
- Mays-1
- Other IDs
- 1K01HL115534
- Acronym
- GAIT
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2014
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02075502
- Acronym / sponsor ID
- GAIT / Mays-1
- Conditions
- Peripheral Artery Disease
- Keywords
- claudication, community walking exercise, community-based participatory research, exercise adherence, endovascular therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
Detailed description
The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Behavioral: Exercise therapyClaudication, no peripheral revasc |
| Exercise advice | Placebo comparator | Behavioral: Exercise therapyClaudication, no peripheral revasc |
| lower extremity ET, exercise therapy | Experimental | Behavioral: Exercise therapy, Procedure: lower extremity ET |
| lower extremity ET, exercise advice | Placebo comparator | Procedure: lower extremity ET |
| Peripheral open intervention, exercise therapy | Experimental | Behavioral: Exercise therapy, Procedure: peripheral open intervention |
| Peripheral open intervention, exercise advice | Placebo comparator | Procedure: peripheral open intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women diagnosed with atherosclerotic PAD
- ≥40 years of age
- An abnormal ankle-brachial index (ABI) of ≤.90
- For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
- Patients receiving lower extremity ET or peripheral open intervention
Key exclusion criteria (24 listed)
- Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill
- Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
- PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
- Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
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 |
|---|---|---|
| Exercise therapyThe exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+). | Behavioural | Exercise advice, Exercise therapy, Peripheral open intervention, exercise therapy, lower extremity ET, exercise therapy |
| lower extremity ETcatheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital) | Procedure or surgery | lower extremity ET, exercise advice, lower extremity ET, exercise therapy |
| peripheral open interventionrevascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital) | Procedure or surgery | Peripheral open intervention, exercise advice, Peripheral open intervention, exercise therapy |
Primary outcome
Change in peak walking time (PWT)
Time frame: Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period
6 secondary outcomes
Change in claudication onset time (COT)
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in patient-reported outcomes
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in peak oxygen uptake
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Change in functional ability
Time frame: Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period
Evaluation of total volume of activity
Time frame: post-12 weeks (exercise and control groups)
Evaluation of exercise adherence
Time frame: post-12 weeks (exercise and control groups)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Click here for more information about the sponsor.Link provided by the sponsor.
- Click here for more information about the sponsor.Link provided by the sponsor.
Related trials for Peripheral Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
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.
Ryan J. Mays, PhD, MPH, MS principal investigator
International Heart Institute of Montana Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy, lower extremity ET and peripheral open intervention in people with Peripheral Artery Disease, run by University of Minnesota at 1 site 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 6 inclusion and 24 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in peak walking time (PWT) (time frame: Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2020.