Health TrialsbyHealthPanel

Passive Calf Stretching Therapy in Peripheral Artery Disease

ConditionsPeripheral Artery DiseaseClaudication, Intermittent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of PAD

Stable condition (PAD symptoms) for at least 3 months

Age 40-85

Men and women who are not pregnant or nursing

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Passive calf muscle stretching device

    Device

    Modified night splints will be used to passive stretch the calf muscle.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: 4-weeks of passive calf stretching for 30 minutes 5 days a weekExperimental treatment 1 intervention
Group B: 4-weeks of no-stretchingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

6-minute walk test distance

Submaximal exercise test used to assess aerobic capacity and endurance

Time frame
6-12 minutes
2

Muscle to tendon ratio

The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound

Time frame
45 minutes
3

Endothelial function

Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.

Time frame
30 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov
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