Leg Heat Therapy in Elderly Individuals

NCT ID: NCT05543980

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-02-28

Brief Summary

This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily for 90 min over 12 consecutive weeks. The primary outcomes were compliance with the HT regimen, measured by a hidden timer, completion rates, and device safety. The secondary goals were to examine the effects of leg HT on 6-min walk distance, sit-to-stand performance, blood pressure, quality of life, and the morphology and strength of the calf muscles, as assessed using combined T1-weighted and mDixon magnetic resonance imaging (MRI). Building upon previous findings in young individuals, preclinical models of PAD, and older individuals with PAD, we hypothesized that older adults treated with leg HT for 12 weeks would display improved walking performance, increased calf strength, and reduced intramuscular fat when compared to sham-treated individuals.

Detailed Description

Aging and a sedentary lifestyle are associated with a progressive deterioration of skeletal muscle contractile function and cardiorespiratory fitness, resulting in an impaired capacity to perform daily activities and maintain independent functioning. Few therapeutic options exist to combat the skeletal muscle abnormalities and restore muscle strength in older individuals. Heat therapy (HT) is a practical, non-invasive therapeutic tool that has been shown to elicit beneficial adaptations in both vasculature and skeletal muscle. This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily for 90 min over 12 consecutive weeks. The primary outcomes were compliance with the HT regimen, measured by a hidden timer, completion rates, and device safety. The secondary goals were to examine the effects of leg HT on 6-min walk distance, sit-to-stand performance, blood pressure, quality of life, and the morphology and strength of the calf muscles, as assessed using combined T1-weighted and mDixon magnetic resonance imaging (MRI). Building upon previous findings in young individuals, preclinical models of PAD, and older individuals with PAD, we hypothesized that older adults treated with leg HT for 12 weeks would display improved walking performance, increased calf strength, and reduced intramuscular fat when compared to sham-treated individuals.

Conditions

Aging; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham control

Participants will be provided a leg heat therapy system and will be instructed to apply the therapy daily (90 min/day) for 12 consecutive weeks. The water heater will circulate water at 33ºC.

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

The leg heat therapy device consists of a water tank coupled with a circulator, a sous-vide water heater and water-circulating trousers. The water heater in the sham device is adjusted to heat up the water to 33ºC.

Heat therapy

Participants will be provided a leg heat therapy system and will be instructed to apply the therapy daily (90 min/day) for 12 consecutive weeks. The water heater will circulate water at 42ºC.

Group Type: EXPERIMENTAL

Leg heat therapy device

Intervention Type: DEVICE

The leg heat therapy device consists of a water tank coupled with a circulator, a sous-vide water heater and water-circulating trousers. The water heater in the sham device is adjusted to heat up the water to 42ºC.

Interventions

Sham device

The leg heat therapy device consists of a water tank coupled with a circulator, a sous-vide water heater and water-circulating trousers. The water heater in the sham device is adjusted to heat up the water to 33ºC.

Intervention Type: DEVICE

Leg heat therapy device

The leg heat therapy device consists of a water tank coupled with a circulator, a sous-vide water heater and water-circulating trousers. The water heater in the sham device is adjusted to heat up the water to 42ºC.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

1. smoking

2. reliance on a walking aid other than a cane

3. having active cancer

4. inability to fit into water-circulating trousers

5. inability to complete the 6-minute walk test

6. being under 65 years of age

7. scoring less than 23 on the Mini-Mental Status Examination (MSSE)

8. having impaired thermal sensation in the leg

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana Clinical and Translational Sciences Institute

OTHER

Sponsor Role: collaborator

American College of Sports Medicine Foundation

UNKNOWN

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Bruno Roseguini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

IRB-2022-381

Identifier Type: -

Identifier Source: org_study_id