Static Muscular Stretching for Treatment of PAD

Sponsor

Florida State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04222751

Collaborator

Mayo Clinic (Other)

Enrollment

Location

Arms

29.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	Device: Ankle Splint	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Static Muscular Stretching for Treatment of Peripheral Artery Disease

Actual Study Start Date :

Jul 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stretch Group Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.	Device: Ankle Splint Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.
Placebo Comparator: No Stretch Group Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.	Device: Ankle Splint Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.

Arm

Intervention/Treatment

Experimental: Stretch Group

Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.

Device: Ankle Splint

Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.

Placebo Comparator: No Stretch Group

Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.

Device: Ankle Splint

Outcome Measures

Primary Outcome Measures

Change in Muscle Oxygenation [4 weeks]
Noninvasive assessment via NIRS monitor
Change in Continuous Walking Distance [4 weeks]
Assessed by 6-minute walking test
Change in Total Walking Distance [4 weeks]
Assessed by 6-minute walking test

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 40+
A resting ankle-brachial index (ABI) of 0.90 or less in either leg
Stable disease (PAD) for a minimum of 3-months

Exclusion Criteria:

Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
Cardiovascular rehabilitation program during the past 3 months
Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
Leg pain at rest
Cardiorespiratory disease
Diabetes
Major surgery or lower extremity revascularization during the previous 3 months
Major medical illness treatment during the prior 12 months
Central neurological disease
Limited ankle or knee joint range of motion
Requirement of oxygen with activity or exercise
More than a class II New York Heart Association level of heart failure
Wheelchair confinement, or inability to walk
Cognitive disorder
Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Florida State University
Mayo Clinic

Investigators

Principal Investigator: Judy Delp, PhD, Florida State University, College of Medicine
Principal Investigator: Emily Pritchard, PhD, Florida State University, College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judy Delp, Professor, Florida State University

ClinicalTrials.gov Identifier:

NCT04222751

Other Study ID Numbers:

19-005234 Mayo
NCT04197609

First Posted:

Jan 10, 2020

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Study Results

No Results Posted as of Mar 18, 2022