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Leg Heat Therapy in Elderly Individuals

NCT05543980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-07-10

No results posted yet for this study

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.

Conditions

  • Aging
  • Muscle Weakness

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER

  • American College of Sports Medicine Foundation

    collaborator UNKNOWN

  • Purdue University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543980 on ClinicalTrials.gov