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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Program | Experimental | Participants will complete a 12-week progressive exercise program with 50-minute sessions three times per week, including warm-up, resistance training, and cool-down. Supervision transitions from primarily in-person (Weeks 1-2) to mixed (Weeks 5-8) and mostly unsupervised with virtual support (Weeks 9-12). Weekly check-ins are provided, and a final assessment occurs at Week 13. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Exercise Program (12 Weeks) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Technology-Assisted Home-Based Exercise Program | 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 ā„80% is considered indicative of acceptable feasibility. | Week 13 (end of intervention and final assessment) |
| Acceptability of Technology-Assisted Home-Based Exercise Program | 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 ā„70% adherence considered acceptable. | Week 13 (end of intervention and final assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance Performance From Baseline to 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. | Baseline and Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liza Durgens | Contact | (409)772-1011 | lidurgen@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mandeep Sandhu, PhD, PT | University of Texas Medial Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch, Galveston | Recruiting | Galveston | Texas | 77555-0133 | United States |
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| Change in Cognitive Function using Montreal Cognitive Assessment (MoCA) | Measured using Montreal Cognitive Assessment (MoCA) scores to detect improvements in executive function and memory. | Baseline and Week 13 |
| Change in Cognitive Function (PROMIS Cognitive Function) | Cognitive function will be assessed using the PROMISĀ® 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. | Baseline and Week 13 |
| Change in Timed Up and Go (TUG) Test Time From Baseline to 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. | Baseline and Week 13 |
| Change in Glycemic Control | Assessed by changes in HbA1C levels to evaluate the metabolic impact of the exercise intervention. | Baseline and Week 13 |
| Change in Hand Grip Strength From Baseline to 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. | Baseline and Week 13 |
| Change in Six-Minute Walk Test Distance From Baseline to 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. | Baseline and Week 13 |
| Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to 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. | Baseline and Week 13 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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