Home-based Leg Heat Therapy to Improve Walking Performance in Elderly Individuals: a Pilot Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Purdue University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Compliance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must be:
- •65 yrs or older
- •Sedentary - Exercise less than three days/week, 20 minutes per day.
- •Non smokers
Exclusion Criteria
- •consisted of:
- •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
Arms & Interventions
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.
Intervention: Sham device (Device)
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.
Intervention: Leg heat therapy device (Device)
Outcomes
Primary Outcomes
Compliance
Time Frame: Baseline to 12-week follow-up
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.
Completion rate
Time Frame: Baseline to 12-week follow-up
Completion rates will be defined as the number of patients attending the follow-up assessments.
Safety
Time Frame: Baseline through 12-week follow-up
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.
Secondary Outcomes
- Triceps surae peak torque(Baseline to 12-week follow-up)
- Repeated chair rises(Baseline to 12-week follow-up)
- Six-minute walk distance(Baseline to 12-week follow-up)
- Triceps sure volume and cross-sectional area(Baseline to 12-week follow-up)
- Short-Form (SF)-36 Questionnaire(Baseline to 12-week follow-up)
- Triceps sure fat content(Baseline to 12-week follow-up)
Investigators
Bruno Roseguini
Associate Professor
Purdue University