Clinical trial NCT04252950: Community-based Exercise Following Revascularization for PAD
Official title: Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: PAD
peripheral artery disease
claudication
revascularization
community-based exercise
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.

Detailed description: Training (T): Patients assigned to the control group will receive verbal advice to exercise but will receive no other training following their revascularization and outcome assessments. Patients in the intervention group will receive supervised SET in the exercise physiology laboratory for one week (3 sessions) following their REVASC and outcome assessments. Patients will then receive 11 weeks of community-based structured exercise therapy (CB-SET) with training, monitoring, and coaching (TMC) and public health elements at home or in the place of their choosing. Patients will be visited by study staff where walking exercise will take place (1 visit per month, 3 total community visits). The purpose of the initial supervised SET is to educate patients about how to exercise and to address any questions they may have (part of the training component of TMC).

Monitoring (M): Participants will be monitored with a piezoelectric accelerometer over the duration of the 12 total weeks to determine total volume of activity. Participants in both groups will be asked to wear the monitors continuously for 7 days per week over a 10 hour period for each day. This amount of activity monitoring has been successfully used in previous studies (minimal user burden, low profile devices). Additionally, participants in both groups will be reminded to wear the monitor during any walking sessions they perform with intent of exercise. The investigators will determine exercise compliance separately for both groups, and participants in the intervention group will be asked to record details about the CB-SET sessions in a provided exercise log (as conducted in a pilot studies). Data from the piezoelectric accelerometers, which are capable of collecting and storing data for \~6 weeks, will be downloaded and reset at the community visits (1 per month). Control participants will be mailed a new device every 4 weeks (with pre-paid mailers given to control participants for return and subsequent download by staff) or will exchange the device during optional once per month visits to the exercise laboratory. At these visits, control pariticipants will have resting heart rate and blood pressure assessed but no CB-SET program will be applied to ensure these participants receive the standard of care regarding home exercise (upfront advice to walk). Participants in the intervention group will also be given commercially available piezoelectric hip pedometers (Omron), which have an interface to track steps, to monitor their own activity. Weekly phone calls (telehealth) will be conducted by study staff with specific prompting to gain a better evaluation of how much and how often intervention group participants are walking (a feasible process evaluation used in the preliminary studies). Questions included to assist in determining treatment fidelity (ensuring the intervention is delivered as intended) during phone calls and from the exercise log: 1) date and start/end times of walking exercise for each session, 2) number of rest stops needed while walking (and reasons for stopping), 3) questions regarding usage of the piezoelectric accelerometer (instructions for use given to participants), 4) number of steps measured from the hip pedometer, 5) what route the participant chose to use for walking as initially defined by the environmental audit (see section below for more details), and 6) what barriers or facilitators the participant encountered during the session ("Any problems while walking around your neighborhood?"). Additionally, participants will be strongly encouraged to walk with family, friends, and pets to increase walking activity. Participants in both groups will receive a smartphone with an application called Daynamica, which will allow users to indicate and store the location where they complete their community-based activities and to annotate specific exercise sessions or other physical activity episodes. Participants in the control group will receive monthly phone calls only to assess the occurrence of any adverse events and to schedule the optional in-hospital visit.

Coaching (C): The investigators will employ an operational coaching model that will provide training guidance and help addressing local barriers to exercise training in the community setting as well as promoting or reinforcing facilitators for each individual participant in the CB-SET intervention group. This will include: 1) educational print materials and 2) environmental auditing. Educational materials developed by Vascular Cures will include informational outreach activities that have been cited as strategies to promote walking by the Task Force Community Preventive Services. Additionally, in providing control participants with the accelerometers, the investigators are in essence providing them "attention", in addition to the monthly phone calls and optional in-hospital "check-ups" with controls. This attention-control design is meant to provide definitive findings that the substantive aspects of the CB-SET program are efficacious and not the result of simply increased contact time with intervention group participants.

Eligibility criteria: Inclusion Criteria:

* Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
* Patients with focal and/or diffuse peripheral artery disease
* Bilateral Revascularization patients will also be included
* Ability to participate in an exercise program

Exclusion Criteria:

* Lower extremity amputation(s) 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 have had a myocardial infarction within 3 months prior to screening
* Individuals who have had a transient ischemic attack or stroke 3 months prior to 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
* Poorly controlled diabetes defined as glycated hemoglobin \>12%
* Abnormal results of blood work not conducive to safely participate in an exercise trial (e.g., anemic, electrolyte abnormalities)
* Inability to speak English
* Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study

Primary outcomes:
measure: Change in Peak Walking Time (PWT)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Claudication Onset Time (COT)
timeFrame: Baseline, 12 weeks
measure: Change in VO2max
timeFrame: Baseline, 12 weeks
measure: Total Volume of Exercise
timeFrame: 12 weeks
measure: Adherence to Exercise
timeFrame: 12 weeks
measure: Change in Walking Impairment Questionnaire (WIQ) Distance Subcategory
timeFrame: Baseline, 12 weeks
measure: Change in Walking Impairment Questionnaire (WIQ) Speed Subcategory
timeFrame: Baseline, 12 weeks
measure: Change in Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory
timeFrame: Baseline, 12 weeks
measure: Change in SF-36 Physical Component Summary
timeFrame: Baseline, 12 weeks
measure: Change in SF-36 Mental Component Summary
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Factor 1: Social Relationships and Interactions
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Factor 2: Self-concept and Feelings
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Factor 3: Symptoms and Limitations in Physical Functioning
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Factor 4: Fear and Uncertainty
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Factor 5: Positive Adaptation
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Question 21: Job/Work
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Question 23: Sex
timeFrame: Baseline, 12 weeks
measure: Change in PADQOL Question 24: Intimate Relationships
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ryan Mays, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: