University of Texas Medical Branch, Galveston
Galveston, Texas, 77555-0133, United States
Location status: Recruiting
NCT Number: NCT07416799
This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period. The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks.
Interested in participating?
Request Info55 year–80 year
All sexes
Interventional
Not applicable
Galveston, Texas, 77555-0133, United States
Location status: Recruiting
The prevalence of T2DM and cognitive impairment increases with age, and these conditions often co-occur, creating compounded health challenges. Physical activity has been shown to benefit both glucose control and cognitive function in older adults. However, traditional supervised exercise programs face barriers, including transportation difficulties, scheduling conflicts, and concerns about exercising in group settings, which are particularly relevant for individuals with cognitive impairment.
Telehealth home-based programs offer a promising solution by providing structured guidance while allowing participants to exercise in familiar environments. The combination of initial supervision transitioning to independent practice addresses both safety concerns and the goal of sustainable behavior change.
Objective:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12-week exercise program with gradual transition from supervised to independent sessions. Participants complete 50-minute sessions, 3 times/week, including:
Warm-up (10 min) Resistance training (35 min): upper arm exercises, wall push-ups, biceps curls, side bends, squats, glute bridges, hip abduction Cool-down (5 min)
Supervision:
Weeks 1-2: Mostly supervised Weeks 5-8: Mixed Weeks 9-12: Mostly unsupervised with Zoom/Teams support
Weekly staff check-ins. Week 13: Repeat baseline tests, questionnaires, blood draw, DEXA scan, and structured interview.
Time frame: Week 13 (end of intervention and final assessment)
Feasibility will be assessed as the proportion of enrolled participants who complete the full 12-week home-based exercise intervention. The completion rate is calculated as the number of participants who complete the intervention divided by the total number of enrolled participants, expressed as a percentage (0% to 100%). A completion rate of ≥80% is considered indicative of acceptable feasibility.
Time frame: Week 13 (end of intervention and final assessment)
Acceptability will be evaluated using exercise adherence, defined as the percentage of prescribed exercise sessions completed during the 12-week intervention period. Adherence will be calculated using data collected from technology monitoring systems and participant self-report logs. Adherence values range from 0% to 100%, with ≥70% adherence considered acceptable.
Time frame: Baseline and Week 13
Balance will be assessed using a standardized clinical balance assessment. Balance performance will be recorded according to the scoring method of the assessment tool used. Change will be calculated as the difference between baseline and Week 13 scores. Higher scores indicate better balance performance.
Time frame: Baseline and Week 13
Measured using Montreal Cognitive Assessment (MoCA) scores to detect improvements in executive function and memory.
Time frame: Baseline and Week 13
Cognitive function will be assessed using the PROMIS® Cognitive Function measure. Scores are reported as T-scores with higher scores indicating better cognitive function. Change is calculated as the difference between baseline and Week 13 T-scores.
Time frame: Baseline and Week 13
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Time to complete the task is recorded in seconds, with lower times indicating better functional mobility. Change is calculated as the difference between baseline and Week 13 TUG times.
Time frame: Baseline and Week 13
Assessed by changes in HbA1C levels to evaluate the metabolic impact of the exercise intervention.
Time frame: Baseline and Week 13
Hand grip strength will be measured using a calibrated hand dynamometer. Grip strength is recorded in kilograms (kg). Change in grip strength will be calculated as the difference between baseline and Week 13 measurements. Higher values indicate greater muscle strength and better physical function.
Time frame: Baseline and Week 13
Functional exercise capacity will be assessed using the Six-Minute Walk Test. Total distance walked in six minutes is recorded in meters. Change will be calculated as the difference between baseline and Week 13 distance walked. Greater walking distance indicates better physical endurance and functional capacity.
Time frame: Baseline and Week 13
Functional independence will be assessed using an Instrumental Activities of Daily Living (IADL) assessment. Scores are reported according to the instrument scoring system, with higher scores indicating greater functional independence. Change is calculated as the difference between baseline and Week 13 scores.
Contact information is provided by the study sponsor or research team.
The University of Texas Medical Branch, Galveston
Other
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.
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