Prehabilitation and Rehabilitation in PAD

Part of paid clinical trials in Palo Alto, California.

Sponsor
Palo Alto Veterans Institute for Research
Study ID
NCT06566976
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention — OTHER
    Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance.
  • VAPAHCS Rehabilitation Core Components — OTHER
    The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal.

Study Details

To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.

Key Dates

Start date
Mar 7, 2024
Status verified
Aug 2024
Primary completion
Jan 31, 2027
Completion
Jul 25, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prehabilitation
    Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed.
  • Active Comparator: Rehabilitation
    Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD.
  • Experimental: Prehabiliation and Rehabilitation
    Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions.

Primary Outcome Measure

Time to claudication pain [ Time Frame: Baseline, 6 weeks, 14 weeks, 22 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304
Jonathan N Myers, PhD
[email protected]
650-493-5000
Charles G Gronau, DCEP
[email protected]
618-746-6956
Jonathan N Myers, PhD (PRINCIPAL_INVESTIGATOR)
Charles G Gronau, DCEP (SUB_INVESTIGATOR)
Khin N Chan, MD (SUB_INVESTIGATOR)
Pallavi Gautam, MPT (SUB_INVESTIGATOR)

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