Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
Primary Purpose
Exercise Training and Sarcopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Training and Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- relatively healthy
Exclusion Criteria:
- relatively unhealthy
Sites / Locations
- University of Texas at Austin Human Performance Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Six months of power training
Outcomes
Primary Outcome Measures
Muscle mass
MRI determined changes in thigh muscle volume
Post-prandial lipemia
The elevation of plasma triglycerides after a meal
Secondary Outcome Measures
Full Information
NCT ID
NCT04641117
First Posted
November 17, 2020
Last Updated
November 17, 2020
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04641117
Brief Title
Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
Official Title
Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
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
Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.
Detailed Description
In a society that is growing in the number of older adults who are also becoming more sedentary, it is critical to identify the types of exercise that harness significant health benefits. First, we hypothesize that older adults (60-80 y) need a certain background level of physical activity, judged by number of steps per day. This is important, especially to fat metabolism. Secondly, because older adults claim they don't have time to exercise, we have developed a time efficient program (10 min/day) that has shown promise for offsetting sarcopenia and significantly improving cardiovascular function.
Our Aim 1 is to determine the range of daily step counts in older adults (60-80 y; n=24) that is needed to prevent acute impairment of post-prandial fat metabolism, measured the morning after exercise. We have recently shown in young adults that when their level of background physical activity drops below the range of 5,000 - 8,500±500 steps/d, that they don't adapt positively to an acute 1 h bout of exercise (i.e.; 'exercise resistance') that normally improves fat metabolism.
Our Aim 2 is to determine the ability of a time-efficient 24-week program of exercise training for both maximal neuromuscular power and aerobic power to counteract sarcopenia and declines in aerobic power and functional tests in men and women 60-80 y. We have recently found in a preliminary study of older men and women (50-70 y) that performing multiple maximal 4 s sprints of rapid acceleration cycling bouts for only 8 weeks, eliciting maximal power, displayed significant (p<0.05) increases in muscle thigh volume (MRI), whole body muscle mass, maximal neuromuscular power and peak oxygen consumption. We now propose to train older men and women (i.e.; 60-80 y; n=60) for longer durations (i.e.; 24 weeks) and describe the time course of adaptations. We will additionally monitor their background levels of daily physical activity and determine if it correlates with improvements in neuromuscular and cardiovascular function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Training and Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will power train
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Six months of power training
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Walking and Power Training
Primary Outcome Measure Information:
Title
Muscle mass
Description
MRI determined changes in thigh muscle volume
Time Frame
six months
Title
Post-prandial lipemia
Description
The elevation of plasma triglycerides after a meal
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
relatively healthy
Exclusion Criteria:
relatively unhealthy
Facility Information:
Facility Name
University of Texas at Austin Human Performance Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
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