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Leg Heat Therapy in Elderly Individuals

Primary Purpose

Aging, Muscle Weakness

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sham device
Leg heat therapy device
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring heat therapy, aging, muscle strength

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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 are: 1) smoking, 2) use of walking aid other than a cane, 3) active cancer, 4) unable to fit into water-circulating trousers, 5) unable to complete the 6-min walk test and 6) age under 65 yrs.

Sites / Locations

  • Purdue UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham control

Heat therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Walking Impairment Questionnaire
The investigators will determine whether home-based leg heat therapy improves the score in the Walking Impairment Questionnaire at 12-week follow-up compared to the sham treatment.
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.
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.
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.
Phosphocreatine recovery time constant
The investigators will determine whether home-based leg heat therapy reduces the phosphocreatine recovery time constant at 12-week follow-up compared to the sham treatment.

Full Information

First Posted
September 13, 2022
Last Updated
September 13, 2022
Sponsor
Purdue University
Collaborators
Indiana Clinical and Translational Sciences Institute, American College of Sports Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05543980
Brief Title
Leg Heat Therapy in Elderly Individuals
Official Title
Home-based Leg Heat Therapy to Improve Walking Performance in Elderly Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Indiana Clinical and Translational Sciences Institute, American College of Sports Medicine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The number of persons aged ≥60 years in the United States is expected to nearly double, from 57 to 109 million between 2010 and 2050. These demographic changes will have profound implications for the healthcare system because advanced age is associated with a heightened risk of negative health outcomes, including disability and frailty. Few therapeutic strategies currently exist to combat the age-related decline in physical functioning that stems from the progressive loss of muscle mass and strength. The goal of the proposed experiments is to determine the benefits of home-based leg heat therapy (HT) in old, sedentary individuals. This novel approach consists of trousers and a portable water pump. Hot water is circulated through the trousers, evenly heating the buttocks, thighs and calf. We propose to conduct a pilot randomized, sham-controlled trial in 20 sedentary, old individuals to establish the effect of daily home-based leg HT for 12 weeks on skeletal muscle size and function, walking performance and perceived quality of life. Participants will be asked to apply the treatment daily for 90 min using water-circulating trousers perfused with water heated to 42ºC (HT group, n=10) or 33ºC (sham group, n=10). The primary study outcomes is the change from baseline in 6-minute walk distance at 12-week follow up. Secondary outcomes include changes in calf muscle strength, as assessed using isokinetic dynamometry , sit-to-stand time, and calf muscle cross-sectional area, fat content and bioenergetics.
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. Our objective is to conduct a pilot randomized, sham-controlled trial in 20 sedentary elderly individuals to establish the effect of home-based leg HT for 12 weeks on walking performance, calf muscle structure, function and metabolism, and on perceived quality of life. Individuals randomized to the leg HT group (n=10) will be asked to apply the treatment daily for 90 min using water-circulating trousers perfused with water heated to 42ºC. In the sham group (n=10), water at 33ºC will be circulated through the trousers. The primary study outcome is the change from baseline 6-minute walk distance at the 12-week follow up. Secondary outcomes include changes in calf muscle cross-sectional area, fat content and bioenergetics, as assessed using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), peak torque of the plantar flexor muscles, as assessed using isokinetic dynamometry, sit-to-stand time, and perceived quality of life. Our working hypotheses are that elderly individuals receiving HT will manifest: 1) improved walking tolerance, 2) greater calf muscle cross-sectional area and volume, 3) enhanced strength of the plantar flexor muscles , 4) lower intramuscular fat content, 5) improved sit-to-stand muscle power, and 6) improved perceived quality of life. Our rationale for this research is that the results obtained can be expected to provide a strong evidence-based framework for the pursuit of a larger randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Muscle Weakness
Keywords
heat therapy, aging, muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Heat therapy
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Sham device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Leg heat therapy device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-minute walk distance
Description
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.
Time Frame
Baseline to 12-week follow-up
Secondary Outcome Measure Information:
Title
Triceps surae peak torque
Description
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.
Time Frame
Baseline to 12-week follow-up
Title
Repeated chair rises
Description
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.
Time Frame
Baseline to 12-week follow-up
Title
Walking Impairment Questionnaire
Description
The investigators will determine whether home-based leg heat therapy improves the score in the Walking Impairment Questionnaire at 12-week follow-up compared to the sham treatment.
Time Frame
Baseline to 12-week follow-up
Title
Short-Form (SF)-36 Questionnaire
Description
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.
Time Frame
Baseline to 12-week follow-up
Title
Triceps sure volume and cross-sectional area
Description
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.
Time Frame
Baseline to 12-week follow-up
Title
Triceps sure fat content
Description
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.
Time Frame
Baseline to 12-week follow-up
Title
Phosphocreatine recovery time constant
Description
The investigators will determine whether home-based leg heat therapy reduces the phosphocreatine recovery time constant at 12-week follow-up compared to the sham treatment.
Time Frame
Baseline to 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants must be: 65 yrs or older Sedentary - Exercise less than three days/week, 20 minutes per day. Non smokers The exclusion criteria are: 1) smoking, 2) use of walking aid other than a cane, 3) active cancer, 4) unable to fit into water-circulating trousers, 5) unable to complete the 6-min walk test and 6) age under 65 yrs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Roseguini, Ph.D
Phone
7654962612
Email
brosegui@purdue.edu
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Roseguini
Phone
765-496-2612
Email
brosegui@purdue.edu

12. IPD Sharing Statement

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Leg Heat Therapy in Elderly Individuals

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