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

Trial Summary

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 data supports the effectiveness of the treatment Passive Calf Stretching Therapy for Peripheral Artery Disease?

Research shows that calf stretching can improve ankle movement and function in older adults and those recovering from injuries, which suggests it might help improve blood flow and mobility in people with Peripheral Artery Disease. ^{1 2 3 4 5}

Is calf stretching therapy safe for humans?

Calf stretching therapy, including passive stretching, is commonly used in physical therapy for various conditions and is generally considered safe for humans. It is important to perform the stretches correctly to avoid strain, especially in conditions like plantar fasciopathy. ^{1 2 4 5 6}

How is Passive Calf Stretching Therapy different from other treatments for Peripheral Artery Disease?

Passive Calf Stretching Therapy is unique because it involves daily stretching exercises that improve blood flow and artery function, which can enhance walking ability in patients with Peripheral Artery Disease. Unlike medications or surgical interventions, this therapy focuses on improving the body's natural blood circulation through non-invasive physical activity. ^{1 2 3 4 7}

What is the purpose of 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Change in Contralateral Muscle Blood Volume During Passive Unilateral Muscle Stretching Before and After Surgery. [2021]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Changes in active ankle dorsiflexion range of motion after acute inversion ankle sprain. [2019]

4. United States 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. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2020]