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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05344001
Other study ID # 3967
Secondary ID DP5OD031833
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2022
Est. completion date August 2027

Study information

Verified date August 2022
Source Marquette University
Contact Jacob J. Capin, DPT, PhD, MS
Phone 414-288-7865
Email jacob.capin@marquette.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. Quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. One modifiable factor that may be associated with long-term health in athletes is physical activity patterns. The purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.


Description:

The overarching hypothesis is that former athletes, especially those with a prior injury, will have poorer function and health in midlife and that current and former athletes will engage in greater overall and longer bouts of sedentary behavior compared to non-athletes. Aim 1 will compare function, strength, and cardiometabolic indicators among former athletes with and without prior knee injury and non-athlete controls in midlife (age 40-64). Hypothesis 1 is that former athletes with a prior injury will have the poorest function, muscle strength, and cardiometabolic indicators. Aim 2 will compare sedentary behavior and physical activity patterns in current (age 18-25) and midlife former athletes to non-athlete controls. Hypothesis 2.1 is that current athletes will have greater sedentary behavior, longer sedentary behavior bouts, and higher levels of moderate-to-vigorous physical activity compared to non-athlete controls. Hypothesis 2.2 is that former athletes in midlife will have greater sedentary behavior, longer sedentary behavior bouts, and lower physical activity levels compared to non-athlete controls. An exploratory aim will evaluate longitudinally the trajectory of physical activity patterns, cardiometabolic indicators, function, and strength annually in each cohort, comparing how these variables change over time in each subgroup.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date August 2027
Est. primary completion date August 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Please see cohorts for specific inclusion/exclusion criteria Inclusion Criteria: - Age 18-25 years OR age 40-64 years - Current or former collegiate varsity athlete OR non-athlete control Exclusion Criteria: - Neurologic (e.g., stroke, Parkinson's) and/or degenerative disease that impairs function - Pregnancy - Lower extremity joint replacement (e.g., hip or knee replacement)

Study Design


Locations

Country Name City State
United States Marquette University Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Marquette University National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-Second Chair Stand Test (primary outcome for Aim 1) Physical function (functional performance) will be evaluated using the 30-Second Chair Stand Test, 6-Minute Walk Test, and Stair Climb Test. The 30-Second Chair Stand Test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. Baseline
Primary Sedentary Behavior (primary outcome for Aim 2) Physical activity will be monitored continuously using an accelerometer worn for 2 weeks. Physical activity will be classified throughout the day as sedentary, light, moderate, or vigorous using established algorithms. The primary outcome for aim 2 is the mean percentage of waking hours in sedentary behavior. Baseline
Secondary Strength Isometric quadriceps and hamstring strength will be assessed using a standardized strength testing machine (i.e., electromechanical dynamometer). Baseline
Secondary Body Composition Body composition (i.e., percent body fat) will be assessed via dual-energy x-ray absorptiometry (DXA). Baseline
Secondary Step Counts Average daily step counts will also be recorded using an objective physical activity monitor. Baseline
Secondary Cardiovascular Disease Risk The American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Estimator will be used in the midlife participants to estimate 10-year cardiovascular disease risk. Baseline
Secondary 6-Minute Walk Test The 6-Minute Walk Test evaluates the distance participants can walk in 6 minutes and is a widely used indicator of function and aerobic capacity. The 6-minute walk test will be evaluated in the midlife participants only. Baseline
Secondary Stair Climb Test The Stair Climb Test assesses the time it takes the participant to ascend and descend a flight of stairs. Faster times on the Stair Climb Test are associated with better strength and function. The Stair Climb Test will be evaluated in the midlife participants only. Baseline
Secondary Sedentary Behavior (follow-up) Physical activity will be monitored continuously using an accelerometer worn for 2 weeks. Physical activity will be classified throughout the day as sedentary, light, moderate, or vigorous using established algorithms. Mean percentage of waking hours in sedentary behavior and each physical activity classification will be assessed. Follow-up (an average of 1 year post-baseline)
Secondary 30-Second Chair Stand Test (follow-up) The 30-Second Chair Stand Test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. Follow-up (an average of 1 year post-baseline)
Secondary Strength (follow-up) Isometric quadriceps and hamstring strength will be assessed using a standardized strength testing machine (i.e., electromechanical dynamometer). Follow-up (an average of 1 year post-baseline)
Secondary Body Composition (follow-up) Body composition (i.e., percent body fat) will be assessed via dual-energy x-ray absorptiometry (DXA). Follow-up (an average of 1 year post-baseline)
Secondary Step Counts (Follow-up) Average daily step counts will also be recorded using an objective physical activity monitor. Follow-up (an average of 1 year post-baseline)
Secondary 6-Minute Walk Test (follow-up) The 6-Minute Walk Test evaluates the distance participants can walk in 6 minutes and is a widely used indicator of function and aerobic capacity. The 6-minute walk test will be evaluated in the midlife participants only. Follow-up (an average of 1 year post-baseline)
Secondary Stair Climb Test (follow-up) The Stair Climb Test assesses the time it takes the participant to ascend and descend a flight of stairs. Faster times on the Stair Climb Test are associated with better strength and function. The Stair Climb Test will be evaluated in the midlife participants only. Follow-up (an average of 1 year post-baseline)
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