Community Walking Exercise for Patients With Peripheral Artery Disease (GAIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by International Heart Institute of Montana Foundation
Sponsor:
Collaborators:
Information provided by (Responsible Party):
International Heart Institute of Montana Foundation
ClinicalTrials.gov Identifier:
NCT02075502
First received: February 13, 2014
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

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).


Condition Intervention
Peripheral Artery Disease
Behavioral: Exercise therapy
Procedure: lower extremity ET
Procedure: peripheral open intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease

Resource links provided by NLM:


Further study details as provided by International Heart Institute of Montana Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Evaluation of total volume of activity [ Time Frame: post-12 weeks (exercise and control groups) ] [ Designated as safety issue: No ]
  • Evaluation of exercise adherence [ Time Frame: post-12 weeks (exercise and control groups) ] [ Designated as safety issue: No ]
    For patients randomized to the exercise therapy group


Estimated Enrollment: 134
Study Start Date: February 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise therapy
Claudication, no ET or open intervention
Behavioral: Exercise therapy
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 (+).
Placebo Comparator: Exercise advice
Claudication, no ET, only exercise advice
Experimental: lower extremity ET, exercise therapy
receive ET, exercise therapy
Behavioral: Exercise therapy
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 (+).
Procedure: lower extremity ET
catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
Placebo Comparator: lower extremity ET, exercise advice
Receive ET, only exercise advice
Procedure: lower extremity ET
catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
Experimental: Peripheral open intervention, exercise therapy
Receive open intervention, exercise therapy
Behavioral: Exercise therapy
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 (+).
Procedure: peripheral open intervention
revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)
Placebo Comparator: Peripheral open intervention, exercise advice
Receive open intervention, only exercise advice
Procedure: peripheral open intervention
revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075502

Contacts
Contact: Ryan J. Mays, PhD, MPH 406-327-1731 ryan.mays@providence.org

Locations
United States, Montana
International Heart Institute of Montana Foundation Recruiting
Missoula, Montana, United States, 59802
Contact: Ryan J. Mays, PhD, MPH    406-327-1731    ryan.mays@providence.org   
Principal Investigator: Ryan J. Mays, PhD, MPH         
Sponsors and Collaborators
International Heart Institute of Montana Foundation
Investigators
Principal Investigator: Ryan J. Mays, PhD, MPH International Heart Institute of Montana Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: International Heart Institute of Montana Foundation
ClinicalTrials.gov Identifier: NCT02075502     History of Changes
Other Study ID Numbers: Mays-1, 1K01HL115534
Study First Received: February 13, 2014
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by International Heart Institute of Montana Foundation:
claudication
community walking exercise
community-based participatory research
exercise adherence
endovascular therapy

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015