Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
Sponsored by The University of Texas Medical Branch, Galveston
About this study
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 behavio…
Where this study is enrolling
- I'm interested
University of Texas Medical Branch, Galveston
Galveston, Texas
Who can participate
Inclusion criteria
- ✓1. Age: 55-80 years
- ✓2. Diabetes: Diagnosed T2DM with ≥5 years duration
- ✓3. Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
- ✓4. Medication Stability: Stable medication regimen for at least 3 months
- ✓5. Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)
- ✓6. Support System: Having a caregiver or support person willing to assist with technology use if needed
Exclusion criteria
- ✕1. Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease
- ✕2. Diagnosis of Alzheimer's disease,
- ✕3. Current diagnosis of severe depression, major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or cooperate fully with the protocol.
- ✕4. Significant cerebral vascular disease
- ✕5. Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including antipsychotics, tricyclic antidepressants, anticonvulsants, sedative/hypnotics, anxiolytics, glucocorticoids (chronic or frequent intermittent),
- ✕6. Visual/hearing impairment that would significantly impact the ability to participate in psychometric testing.
- ✕7. Significant medical illness or organ failure, including hepatic or renal failure, unstable cardiac disease,
- ✕8. Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable).
- ✕9. Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable).
- ✕10. Stage 5 renal impairment (GFR less than 15 or dialysis).
- ✕11. Participation in another clinical trial.
- ✕12. Prisoners.
- ✕13. Exercise Contraindications: Any condition that would make moderate-intensity exercise unsafe such as a history of severe aortic stenosis, poorly controlled hypertension, angina, or syncope.
- ✕14. Lack of Support: No available caregiver or support person for technology assistance
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Trial data sourced from ClinicalTrials.gov.