Clinical trial NCT05543980: Leg Heat Therapy in Elderly Individuals
Official title: Home-based Leg Heat Therapy to Improve Walking Performance in Elderly Individuals: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Muscle Weakness
Keywords: heat therapy
aging
muscle strength
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Indiana Clinical and Translational Sciences Institute
name: American College of Sports Medicine Foundation
First posted: 2022-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Participants must be:

1. 65 yrs or older
2. Sedentary - Exercise less than three days/week, 20 minutes per day.
3. Non smokers

The exclusion criteria consisted of:

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

Primary outcomes:
measure: Compliance
timeFrame: Baseline to 12-week follow-up
measure: Completion rate
timeFrame: Baseline to 12-week follow-up
measure: Safety
timeFrame: Baseline through 12-week follow-up
Secondary outcomes:
measure: Triceps surae peak torque
timeFrame: Baseline to 12-week follow-up
measure: Repeated chair rises
timeFrame: Baseline to 12-week follow-up
measure: Short-Form (SF)-36 Questionnaire
timeFrame: Baseline to 12-week follow-up
measure: Triceps sure volume and cross-sectional area
timeFrame: Baseline to 12-week follow-up
measure: Triceps sure fat content
timeFrame: Baseline to 12-week follow-up
measure: Six-minute walk distance
timeFrame: Baseline to 12-week follow-up
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References: