Effects of Passive Muscle Stretching on Vascular Function and Symptoms of PAD

NCT03288181 | Completed

• 1 other identifier: 2015-25
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with peripheral arterial disease often have walking impairment due to insufficient oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus muscle arterioles and blood flow during exercise. The effect of muscle stretching on endothelial function and walking distance in patients with peripheral arterial disease is unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients with stable symptomatic peripheral artery disease. Patients were randomized to undergo either 4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day, 5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa. Endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6 minute walk test were repeated.

Conditions

Peripheral Arterial Disease; Claudication

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilatation of the Popliteal Artery

  Ultrasound assessment of flow mediated dilatation of the popliteal artery

  Performed 4 weeks after each intervention

Secondary Outcomes (1)

• Six Minute Walk Test

  Performed 4 weeks after each intervention

Study Arms (2)

Muscle Stretch Group

EXPERIMENTAL

This is the group who applies the splint to stretch the calf muscles as per the described protocol for 4 weeks.

Device: Muscle Stretch

Control Arm

NO INTERVENTION

This is the group who has undergone no splint for 4 weeks.

Interventions

Muscle Stretch DEVICE

The splint will be applied to the affected leg as per the protocol for 30 minutes per day, 5 days per week for 4 weeks.

Muscle Stretch Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable symptomatic peripheral arterial disease

You may not qualify if:

• critical limb ischemia
• severe comorbid conditions that limit walking ability

Sponsors & Collaborators

• Tallahassee Research Institute, Inc.: lead
• Florida State University: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wayne Batchelor, MD

  Tallahassee Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: October 5, 2015
• Primary Completion: May 30, 2016
• Study Completion: June 15, 2016
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share