Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580964
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Heat and Exercise in Aging as Therapy HEAT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes Impact of Local Heat Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAT
Brief Summary:
The main goal of this two-phase clinical trial is to learn whether local heat therapy using heat pads applied to the legs can enhance skeletal muscle health physical function and blood sugar control in a manner comparable to exercise specifically High-Intensity Interval Training HIIT in older individuals with prediabetes The study aims to answer the following questions
1 Does local heat therapy improve muscle architecture eg muscle cross-sectional area capillary density mitochondrial content glucose tolerance and frailty indicators similarly to HIIT in older individuals with prediabetes
2 Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes
1 Does local heat therapy improve muscle architecture eg muscle cross-sectional area capillary density mitochondrial content glucose tolerance and frailty indicators similarly to HIIT in older individuals with prediabetes
2 Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes
Detailed Description:
To achieve the study objectives researchers will first compare the outcomes of local heat therapy to 1 HIIT and 2 heat pads set to maintain normal skeletal muscle temperature control group Then researchers will compare the outcomes of the local heat therapy and control groups after a subsequent HIIT intervention This will enable the researchers to assess the effectiveness of local heat therapy compared to HIIT and preceding HIIT to improve skeletal muscle health physical function blood sugar control
Study Procedures
All participants will visit the laboratory over three days at the start of the study for baseline assessments and sample collection
Participants in the Control CON and Local Heat Therapy LHT groups will
Phase 1
Use heat pads on both thighs at a pre-determined temperature for 90 minutes daily 7 days a week 6 days at home and 1 day in the laboratory 12 laboratory visits for the first 12 weeks
Maintain a log of each heat pad session
Visit the laboratory over three days at the end of Phase 1 for follow-up assessments and sample collection
Phase 2
Visit the laboratory three days per week for 12 weeks a total of 36 visits for exercise training
Visit the laboratory over three days at the end of Phase 2 for final assessments and sample collection
Participants in the HIIT Group will
Phase 1
Visit the laboratory three days per week for 12 weeks a total of 36 visits for exercise training
Visit the laboratory over three days at the end of Phase 1 for final assessments and sample collection
Study Procedures
All participants will visit the laboratory over three days at the start of the study for baseline assessments and sample collection
Participants in the Control CON and Local Heat Therapy LHT groups will
Phase 1
Use heat pads on both thighs at a pre-determined temperature for 90 minutes daily 7 days a week 6 days at home and 1 day in the laboratory 12 laboratory visits for the first 12 weeks
Maintain a log of each heat pad session
Visit the laboratory over three days at the end of Phase 1 for follow-up assessments and sample collection
Phase 2
Visit the laboratory three days per week for 12 weeks a total of 36 visits for exercise training
Visit the laboratory over three days at the end of Phase 2 for final assessments and sample collection
Participants in the HIIT Group will
Phase 1
Visit the laboratory three days per week for 12 weeks a total of 36 visits for exercise training
Visit the laboratory over three days at the end of Phase 1 for final assessments and sample collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None