Claudication, Intermittent, Peripheral Artery Disease
Conditions
Keywords
Endothelial dysfunction
Brief summary
The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are: 1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health. 2. To determine if daily calf muscle stretching at home improves walking performance. Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.
Detailed description
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.
Interventions
DEVICEPassive calf muscle stretching device
Modified night splints will be used to passive stretch the calf muscle.
Sponsors
American Heart Association
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.
Intervention model description
Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Presence of PAD * Stable condition (PAD symptoms) for at least 3 months * Age 40-85 * Men and women who are not pregnant or nursing
Exclusion criteria
* Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene) * Any condition other than PAD that limits the ability to walk * Major surgery or lower extremity revascularization surgery in the past 6 months * Myocardial infarction within past 6 months or unstable angina * Severe lung disease (on supplemental oxygen or frequently use rescue inhalers) * Participants with non-compressible vessels (ABI \> 1.40) * Habitual exercise (30 minutes of continuous activity on 3 or more days per week) * Current tobacco smoker or use of nicotine-containing products * Pregnant or nursing women * History or ankle reconstruction or surgery Recent history (\<1 year) of injuries to the ankle, Achilles tendon, or feet * History of rheumatoid arthritis or other degenerative joint disease * Major medical illness treatment during the prior 12 months * Uncontrolled hypertension * Uncontrolled diabetes * Inability to walk on a treadmill at a slow pace (1.0 mile/hour)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test distance | 6-12 minutes | Submaximal exercise test used to assess aerobic capacity and endurance |
| Muscle to tendon ratio | 45 minutes | The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound |
| Endothelial function | 30 minutes | Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg. |
Countries
United States
Contacts
Primary ContactDavid N Proctor, Ph.D.
Backup ContactJocelyn M Delgado, B.S.
Outcome results
None listed