Leg Heat Therapy in Elderly Individuals

NCT05543980 | Completed Phase 1 DMC

• 1 other identifier: IRB-2022-381
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Muscle Weakness

Keywords

heat therapy; aging; muscle strength

Outcome Measures

Primary Outcomes (3)

• Compliance

  A built-in timer inside the pump that is inaccessible to participants will provide one assessment of patient compliance with the therapy. Compliance will be determined by dividing the number of hours of HT recorded use by the required hours. In addition, patients in both groups will receive a logbook to record their treatment sessions.

  Baseline to 12-week follow-up

• Completion rate

  Completion rates will be defined as the number of patients attending the follow-up assessments.

  Baseline to 12-week follow-up

• Safety

  The study coordinator will call patients weekly to record: 1) the dates and times in which the treatment was applied, 2) BP values prior to and immediately after the end of each session, 3) the occurrence of symptoms, such as faintness or dizziness after exposure to the therapy, and 4) changes in medical status or medications. Adverse events (AEs) will be tracked throughout the study and used as a surrogate for safety-related outcomes.

  Baseline through 12-week follow-up

Secondary Outcomes (6)

• Triceps surae peak torque

  Baseline to 12-week follow-up

• Repeated chair rises

  Baseline to 12-week follow-up

• Short-Form (SF)-36 Questionnaire

  Baseline to 12-week follow-up

• Triceps sure volume and cross-sectional area

  Baseline to 12-week follow-up

• Triceps sure fat content

  Baseline to 12-week follow-up

Study Arms (2)

Sham control

SHAM COMPARATOR

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.

Device: Sham device

Heat therapy

EXPERIMENTAL

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.

Device: Leg heat therapy device

Interventions

Sham device 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.

Sham control

Leg heat therapy device 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.

Heat therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• smoking
• reliance on a walking aid other than a cane
• having active cancer
• inability to fit into water-circulating trousers
• inability to complete the 6-minute walk test
• being under 65 years of age
• scoring less than 23 on the Mini-Mental Status Examination (MSSE)
• having impaired thermal sensation in the leg

Sponsors & Collaborators

• Purdue University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator
• American College of Sports Medicine Foundation: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Muscle Weakness; Hyperthermia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 5, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (1)