Back to resultsPassive Calf Stretching Therapy in Peripheral Artery Disease
Primary Purpose
Peripheral Artery Disease, Claudication, Intermittent
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive calf muscle stretching device
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Endothelial dysfunction
Eligibility Criteria
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)
Sites / Locations
- Penn State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
4-weeks of passive calf stretching for 30 minutes 5 days a week
4-weeks of no-stretching
Arm Description
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.
Outcomes
Primary Outcome Measures
6-minute walk test distance
Submaximal exercise test used to assess aerobic capacity and endurance
Muscle to tendon ratio
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
Endothelial function
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
Secondary Outcome Measures
Full Information
NCT ID
NCT06041880
First Posted
September 11, 2023
Last Updated
September 15, 2023
Sponsor
Penn State University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT06041880
Brief Title
Passive Calf Stretching Therapy in Peripheral Artery Disease
Official Title
To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Claudication, Intermittent
Keywords
Endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4-weeks of passive calf stretching for 30 minutes 5 days a week
Arm Type
Experimental
Arm Description
A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
Arm Title
4-weeks of no-stretching
Arm Type
No Intervention
Arm Description
No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.
Intervention Type
Device
Intervention Name(s)
Passive calf muscle stretching device
Other Intervention Name(s)
Plantar fasciitis night splints
Intervention Description
Modified night splints will be used to passive stretch the calf muscle.
Primary Outcome Measure Information:
Title
6-minute walk test distance
Description
Submaximal exercise test used to assess aerobic capacity and endurance
Time Frame
6-12 minutes
Title
Muscle to tendon ratio
Description
The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
Time Frame
45 minutes
Title
Endothelial function
Description
Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David N Proctor, Ph.D.
Phone
814-571-5234
Email
dnp3@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn M Delgado, B.S.
Phone
408-679-8390
Email
jmd956@psu.edu
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Passive Calf Stretching Therapy in Peripheral Artery Disease
We'll reach out to this number within 24 hrs