Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
Location contact
Mattie E Pontiff, PT DPT PhD
CONTACT
Mattie E Pontiff, PT DPT PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07210645
The overall purpose of this study is to develop a power training intervention in partnership with Veterans participating in Gerofit and to evaluate the program's acceptability, feasibility, and preliminary participant outcomes (leg power, physical function and self-report participation).
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045-7211, United States
Mattie E Pontiff, PT DPT PhD
CONTACT
Mattie E Pontiff, PT DPT PhD
PRINCIPAL_INVESTIGATOR
The overall purpose of this project is to co-design a power training intervention for Veterans engaged in Gerofit and to assess its feasibility, acceptability, and preliminary participant outcomes. Gerofit Veterans and exercise providers will participate in co-designing the power training intervention through interviews and feedback sessions. The power training program developed will be tested in the subsequent randomized feasibility pilot. This pilot aims to evaluate the feasibility, acceptability, and preliminary outcomes of a power training program in older Veterans participating in Gerofit using an explanatory sequential mixed methods design. Veterans newly enrolled in the Gerofit program will be randomized into power training and standard of care groups and will participate in exercise sessions over 6 months. Feasibility and acceptability will be assessed by Veteran adherence to program components and by validated surveys. Quantitative data collection will inform qualitative interviews with Veterans on the acceptability and feasibility of the power training program at its completion. Clinical outcomes will be collected (leg power, physical function, and self-report participation) at baseline, 3 months and 6 months and will be compared between the Gerofit power training and Gerofit standard of care groups. Study findings will lead to the development of a power training program that optimally meets Veteran and Gerofit program needs. In addition, study outcomes will guide implementation of a power training program into Gerofit programs aimed at enhancing mobility outcomes in older Veterans.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pilot Study Criteria:
Exclusion criteria
Gerofit Power Training will include a power training exercise prescription which will focus on having participants perform concentric portions of each resistance exercise as fast and as safely as possible with the eccentric component performed in a slow and controlled manner. The target dose of the power training intervention is 40-60% of the participant's 1-repetition maximum for 4-6 repetitions across 3-6 sets for each exercise. Exercises will focus on the major groups of the upper and lower body. All other Gerofit program components (balance, aerobic, and flexibility) will be consistent with the standard of care group. Sessions will be the same duration as the standard of care Gerofit group (60-75 minutes). The power training and standard of care groups will only differ in the form of resistance training performed.
Gerofit standard of care is a 60-75 minute multimodal exercise program which includes 20-30 minutes of aerobic training, traditional strength training of the major upper and lower body muscle groups (1-3 sets of 8-12 repetitions at moderate load), flexibility training and balance training.
Time frame: assessed at 3-months (primary endpoint) and 6 months in both intervention and standard of care groups
Adherence will be measured as a proportion of the number of sessions attended out of the number prescribed per protocol.
Time frame: assessed at 3-months (primary) and 6 months
Retention will be tracked as part of feasibility and to inform a future trial. Retention will be measured as the proportion of Veterans who complete all outcome measure timepoints out of the total who complete baseline measures.
Time frame: assessed at 3-months (primary) and 6 months
Feasibility will be measured through a validated survey: Feasibility of Intervention Measure which consists of 4 items rated on a 5-point Likert scale ranging from (1) completely disagree to (5) complete agree. Higher scores indicate greater feasibility of the program. Measure will only be collected in the intervention group.
Time frame: assessed at 3-months (primary) and 6 months
Acceptability will be measured through a validated survey: Theoretical Framework of Acceptability Measure which consists of 8 items rated on a 5-point Likert scale ranging from (1) did not like, high burden to (5) strongly liked, low burden. Higher scores indicate greater acceptability of the program. Measure will only be collected in the intervention group.
Time frame: baseline, 3-months and 6 months
Leg power will be evaluated using previously validated methods in older adults at 40% and 70% of the Veterans 1-repetition maximum over 5 repetitions. Scores are continuous, higher scores indicate greater leg power (better outcome).
Time frame: baseline, 3-months and 6 months
Power in Watts will be measured using a valid and reliable test which calculates power from time, body weight and stair height when participants climb 4 steps as fast as possible. Scores are continuous, higher scores indicate greater leg power (better outcome).
Time frame: baseline, 3-months and 6 months
This is a functional test of mobility. Participants will be timed while walking at self-selected and fast speeds for 10 meters. Gait speed in meters per second will calculated for self-selected and fast gait speeds. Scores are continuous, higher scores indicate greater greater gait speed and mobility (better outcome).
Time frame: baseline, 3-months and 6 months
Participants will complete this valid and reliable self-report measure of physical function (32 items) and disability (16 items). Raw summary scores are transferred to scaled summary scores on a 0-100 scale with higher scores indicated greater function and greater participation in life tasks.
Time frame: baseline, 3-months and 6 months
This is a functional test of leg strength and power. Participants are asked to stand up and sit down as many times as they can in 30 seconds from a standard height chair. Scores are continuous, higher scores indicate greater leg strength and power (better outcome).
Time frame: baseline, 3-months and 6 months
This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (bicep curls) as possible in 30 seconds. Males use an 8lb weight and females use a 5 lb weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome).
Time frame: baseline, 3-months and 6 months
This is a functional test of aerobic capacity. Participants walk as far as they can along a preset track in 6 minutes. Score is the maximal distance walked in 6 minutes, measured in meters. Scores are continuous, and higher scores indicate greater aerobic capacity (better outcome).
Time frame: baseline, 3-months and 6 months
This is a test of lower body muscle strength. Participants will perform a 1-repetition maximum leg press test where they press the heaviest load they can 1 time through their full range of motion with good form. The test is scored in pounds. Scores are continuous, and higher scores indicate greater leg strength (better outcome).
Contact information is provided by the study sponsor or research team.
Jennifer E Stevens-Lapsley, PhD
CONTACT
Mattie E Pontiff, PT DPT PhD
CONTACT
VA Office of Research and Development
Fed
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07494721
Physical Deconditioning
View Trial DetailsNCT06288438
Behavior, Motor Activity
Aurora, Colorado, United States
View Trial DetailsNCT04942613
Behavior, Motor Activity
Aurora, Colorado, United States
View Trial DetailsNCT06788054
Behavior, Body Composition
León, Guanajuato, Mexico
View Trial Details