The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05712395
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Exercise — BEHAVIORAL
    Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.

Study Details

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).

Key Dates

Start date
Sep 9, 2024
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

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

Arms

  • Experimental: Non-Ischemic Exercise (NICE) exercise program
    Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.
  • Active Comparator: Standard exercise program
    Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.

Primary Outcome Measure

Peak Walking Time [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
O'Donoghue Research Building, University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73117
Andrew W. Gardner, Ph.D.
[email protected]
405-271-4742

Find similar trials in Oklahoma City, OK

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
O'Donoghue Research Building, University of Oklahoma Health Sciences Center· Oklahoma City, OK

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