Calf Stretching Therapy for Peripheral Artery Disease

Overseen By Jocelyn M Delgado, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Ischemic leg pain, Major surgery, Myocardial infarction, Severe lung disease, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily calf muscle stretching can help individuals with peripheral artery disease (PAD) feel better and walk more easily. Researchers aim to determine if using inflatable ankle splints for 30 minutes a day, five days a week, improves muscle and blood vessel health and walking performance. The trial seeks participants with PAD who have had stable symptoms for at least three months and are not currently smokers or using nicotine products. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for PAD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this calf stretching therapy is safe for patients with peripheral artery disease?

Research shows that gently stretching calf muscles can be safe for people with peripheral artery disease (PAD). Studies have found that daily stretching can improve blood flow and ease walking for those with PAD. Importantly, no major negative effects have been reported from this therapy. Most people find using a special ankle brace for stretching comfortable, making it a promising method to enhance leg and blood vessel health. Overall, this therapy appears to be a safe option for managing PAD symptoms through daily stretching. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because passive calf stretching could offer a non-invasive, simple alternative to improve blood flow in people with Peripheral Artery Disease (PAD). Unlike standard treatments such as medication or surgery that target blood vessels directly, this method uses a modified ankle splint to gently stretch the calf muscles, potentially enhancing circulation naturally. This approach could provide a cost-effective and accessible option for managing PAD symptoms without the need for complex procedures or drugs.

What evidence suggests that passive calf stretching therapy is effective for peripheral artery disease?

This trial will compare the effects of passive calf stretching therapy with no stretching in individuals with peripheral artery disease (PAD). Research has shown that gently stretching the calf muscles can improve blood flow and ease walking for people with PAD. Studies have found that this type of stretching boosts blood vessel health and helps patients walk more comfortably. For those with PAD, these benefits can enhance daily activities and reduce symptoms. Stretching the calf muscles has proven especially helpful for older adults with PAD by improving blood vessel function. Overall, this therapy appears promising for enhancing both circulation and movement in people with this condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-85 with stable peripheral artery disease (PAD) symptoms for at least three months. They must not be pregnant, nursing, or have had major surgeries recently. Excluded are those with uncontrolled diabetes, recent heart issues, habitual exercisers, ankle injuries within a year, severe lung disease, current smokers or nicotine users.

Inclusion Criteria

I am not pregnant or nursing.

My symptoms for peripheral artery disease have been stable for 3 months.

I have peripheral artery disease (PAD).

Exclusion Criteria

You are currently smoking or using products that contain nicotine.

I frequently use oxygen or rescue inhalers due to severe lung disease.

You have a certain test result showing that your blood vessels cannot be compressed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo passive calf stretching using inflatable ankle splints for 30 minutes a day, 5 days a week for 4 weeks

4 weeks

Home-based, daily

No-stretching period

Participants do not use the stretching device and continue with normal daily activities for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Passive Calf Stretching Therapy

Trial Overview The study tests if using an inflatable calf muscle stretching device at home can improve muscle and vascular health as well as walking performance in PAD patients. Participants will stretch daily for 30 minutes over four weeks followed by four weeks without stretching.

How Is the Trial Designed?

Group I: 4-weeks of passive calf stretching for 30 minutes 5 days a week Experimental Treatment 1 Intervention

A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.

Group II: 4-weeks of no-stretching Active Control 1 Intervention

No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

An eight-week calf muscle stretching program significantly improved dorsiflexion range of motion and passive properties of the calf muscles in older women, indicating enhanced muscle flexibility and elasticity.

Participants in the stretching group also demonstrated improved performance in agility and walking speed, suggesting that the stretching program positively impacted their functional mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an eight-week stretching program on the passive-elastic properties and function of the calf muscles of older women. Gajdosik, RL., Vander Linden, DW., McNair, PJ., et al.[2022]

In a study involving 22 participants with acute ankle inversion sprains, active ankle dorsiflexion range of motion (AADFROM) significantly improved over 6 weeks, indicating effective recovery from the injury.

By 4 weeks post-injury, AADFROM returned to normal levels, demonstrating that a standardized home exercise program can effectively restore ankle mobility after an acute sprain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in active ankle dorsiflexion range of motion after acute inversion ankle sprain. Youdas, JW., McLean, TJ., Krause, DA., et al.[2019]

Passive stretching may not be the most effective method for treating muscle contractures due to its tendency to activate the stretch reflex and lack of long-term benefits.

The paper outlines four alternative approaches to treating muscle contractures, including strengthening opposing muscles and inhibiting the contracted muscle, which may provide more effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of physical therapy alternatives for reducing muscle contracture. Cherry, DB.[2019]

In a study involving eight patients with esophageal cancer, unilateral passive stretching of the gastrocnemius muscle before and after surgery was shown to affect blood volume in the non-stretched (contralateral) muscle, indicating a potential systemic effect of localized stretching.

The results suggest that while the stretched muscle experienced changes in blood volume during stretching, the contralateral muscle exhibited an inversely synchronized response, highlighting the need for further investigation into the underlying mechanisms of this phenomenon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Contralateral Muscle Blood Volume During Passive Unilateral Muscle Stretching Before and After Surgery. Kutsuzawa, T., Matsumoto, H., Kurita, D., et al.[2021]

Stretching the calf muscles is crucial for effectively treating plantar fasciopathy, a common foot condition.

Maintaining proper alignment of the lower limb during stretching can help prevent strain on the plantar fascia, and a clinical method is provided to assist patients in achieving this alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calf stretching in correct alignment. An important consideration in plantar fasciopathies. Silvester, M.[2017]

Both prolonged static and cyclic calf stretching significantly reduced ankle joint stiffness in individuals with ischemic stroke, with a 35% decrease after static stretching and a 30% decrease after cyclic stretching.

Static stretching resulted in greater torque relaxation (53% more) compared to cyclic stretching, but neither stretching method improved walking speed in the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of prolonged static and cyclic stretching on ankle joint stiffness, torque relaxation, and gait in people with stroke. Bressel, E., McNair, PJ.[2016]

In a study involving 13 patients with peripheral arterial disease (PAD), daily passive calf muscle stretching for 4 weeks significantly improved endothelial function and walking ability, as measured by flow-mediated dilation (FMD) and the 6-minute walk test (6MWT).

The results showed that after stretching, FMD increased from 3.7% to 5.1% and walking distance improved from 182 meters to 304 meters, indicating that stretching can enhance blood flow and mobility in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Passive Muscle Stretching Improves Flow-Mediated Dilation of Popliteal Artery and 6-minute Walk Test in Elderly Patients with Stable Symptomatic Peripheral Artery Disease. Hotta, K., Batchelor, WB., Graven, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6698217/

Daily Passive Muscle Stretching Improves Flow-Mediated ... Conclusions: Passive calf muscle stretching enhanced vascular endothelial function and improved walking function in elderly patients with stable symptomatic PAD ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06041880/passive-calf-stretching-therapy-in-peripheral-artery-disease

Passive Calf Stretching Therapy in Peripheral Artery Disease The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery ...

3. withpower.com withpower.com/trial/phase-2-peripheral-arterial-disease-4-2024-da75d

Passive Stretching for Peripheral Arterial Disease Research shows that daily passive stretching of calf muscles can improve blood flow and walking ability in patients with peripheral arterial disease.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155383891930301X

Daily Passive Muscle Stretching Improves Flow-Mediated ... Passive calf muscle stretching enhanced vascular endothelial function and improved walking function in elderly patients with stable symptomatic PAD. These ...

5. hhd.psu.edu hhd.psu.edu/kines/research/featured-research-projects/studying-how-stretching-can-improving-circulation

Can stretching improve circulation and ability to walk? This study will examine whether at-home calf stretching can reduce peripheral artery disease (PAD) symptoms by improving blood flow, increasing mobility, and ...

6. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT06041880?keyword=%22Claudication%2C%20Intermittent%22

Passive Calf Stretching Therapy in Peripheral Artery Disease 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.