University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT07715344
The purpose of the study is to pilot test of PAfitME™ among (1) young adults (YA) cancer patients of color (POC) (Analytic Sample [N=36] after attrition of 30%) and (2) YA cancer patients of White (POW) (Analytic Sample [N=36] after attrition of 30%).
Aim 1: Evaluate Exergame Grading Scheme (EGS) validity when EGS is tested in relationship to standard lab tests (Bruce Treadmill Protocol and isometric/isokinetic dynamometry) and field fitness tests (6-minute walk test, handgrip, and Chair Stand Test).
Aim 2a: Evaluate the feasibility (enrollment rate [% of eligible patients], attrition rate [% in either intervention or control group], adherence rate [% of completed prescribed exergame minutes]), safety (numbers of adverse events), and acceptability (satisfaction score & exit qualitative interviews) of PAfitME™.
Aim 2b: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POC.
Aim 2c: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POW.
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Notify Me18 year–39 year
All sexes
Interventional
Early Phase 1
Birmingham, Alabama, 35233, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PAfitME™, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principle of adaptation (cardiorespiratory and skeletal muscle functional adaptation and remodeling in response to frequent physical activity stimuli). PAfitME™ is personalized to the patient's PA barriers: (1) fitness capacities, (2) PA health beliefs (self-efficacy and enjoyment), and (3) fatigue/pain levels. PAfitME™, delivered via FaceTime/Zoom calls, uses commercially available exergaming platforms (Nintendo). Innovative features of PAfitME™ include personalizing the exergame platform to deliver (1) a home-based telehealth intervention to overcome PA barriers in order to improve PA self-efficacy, PA enjoyment, and subsequent PA behavior; (2) a technological approach with dynamic visual feedback to assure PA accuracy and competence; and (3) a real-time assessment of individual exergame performanance.
Time frame: Baseline and Week 12
6-minute walk. The distance (in meters) walked in 6 minutes is measured.
University of Alabama at Birmingham
Other
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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.
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