AgingPhase 1NCT05543980
Leg Heat Therapy in Elderly Individuals
A Phase 1 study testing Leg heat therapy device in people with Aging and Muscle Weakness, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscle Weakness
- What is being tested?
- Leg heat therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2022to 28 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Participants must be:
- 65 yrs or older
- Sedentary - Exercise less than three days/week, 20 minutes per day.
- Non smokers
The exclusion criteria consisted of:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Leg Heat Therapy to Improve Walking Performance in Elderly Individuals: a Pilot Trial
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.
Read the 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
- Being tested
- Sham device, Leg heat therapy device
- Keywords
- heat therapy, aging, muscle strength
- Medical subject headings
- Muscle Weakness, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham deviceDevice
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.
Leg heat therapy deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Leg heat therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12-week follow-up
Completion rate
Completion rates will be defined as the number of patients attending the follow-up assessments.
Measured: 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.
Measured: Baseline through 12-week follow-up
Secondary outcomes (6)
Triceps surae peak torque
The investigators will determine whether home-based leg heat therapy improves the peak torque of the triceps surae at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Repeated chair rises
The investigators will determine whether home-based leg heat therapy improves the time to complete 5 chair rises at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Short-Form (SF)-36 Questionnaire
The investigators will determine whether home-based leg heat therapy improves the score in the Short-Form (SF)-36 Questionnaire at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Triceps sure volume and cross-sectional area
The investigators will determine whether home-based leg heat therapy enhances the volume and cross-sectional area of the triceps sure at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Triceps sure fat content
The investigators will determine whether home-based leg heat therapy reduces the fat content of the triceps sure at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Six-minute walk distance
The investigators will determine whether home-based leg heat therapy improves the 6-minute walk distance at 12-week follow-up compared to the sham treatment.
Measured: Baseline to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Sep 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, American College of Sports Medicine Foundation
- Responsible party
- Principal investigator, Bruno Roseguini, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543980
- Sponsor's protocol ID
- IRB-2022-381
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Leg Heat Therapy to Improve Walking Performance in Elderly Individuals: a Pilot Trial
- ClinicalTrials.gov ID
- NCT05543980
- Acronym / sponsor ID
- IRB-2022-381
- Conditions
- Aging, Muscle Weakness
- Keywords
- heat therapy, aging, muscle strength
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, American College of Sports Medicine Foundation
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham control | Sham comparator | Device: Sham deviceParticipants 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. |
| Heat therapy | Experimental | Device: Leg heat therapy deviceParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham deviceThe 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 | Sham control |
| Leg heat therapy deviceThe 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. | Device | Heat therapy |
Primary outcome
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.
6 secondary outcomes
Triceps surae peak torque
Time frame: Baseline to 12-week follow-up
Repeated chair rises
Time frame: Baseline to 12-week follow-up
Short-Form (SF)-36 Questionnaire
Time frame: Baseline to 12-week follow-up
Triceps sure volume and cross-sectional area
Time frame: Baseline to 12-week follow-up
Triceps sure fat content
Time frame: Baseline to 12-week follow-up
Six-minute walk distance
Time frame: Baseline to 12-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leg heat therapy device in people with Aging and Muscle Weakness, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: Baseline to 12-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.