Technology-assisted home strength training for adults 55–80 with type 2 diabetes and mild cognitive impairment
Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
This 12-week program will test whether a telehealth-supported home strength-training routine helps adults 55–80 with type 2 diabetes and mild cognitive impairment stick with exercise and improve strength, thinking, and blood sugar.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT07416799 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, pre–post feasibility study delivering a 12-week progressive resistance exercise program at home with telehealth support. The program begins with supervised sessions and gradually shifts to independent sessions to promote safety and sustainable habits. Outcomes include adherence rates, physical function, cognitive tests, and measures of glycemic control, with qualitative interviews to identify barriers and facilitators. The design focuses on whether technology-assisted home delivery is practical and acceptable for this population.
Who should consider this trial
Good fit: Adults aged 55–80 with at least five years of diagnosed type 2 diabetes, MoCA scores of 18–25 consistent with mild cognitive impairment, stable medications, physician clearance for moderate exercise, and a caregiver or support person available to help with technology.
Not a fit: People with Alzheimer’s disease, significant movement disorders, major cerebrovascular disease, severe psychiatric illness, inability to safely perform moderate exercise, or no caregiver/technology access are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could offer an accessible way for older adults with diabetes and mild cognitive impairment to improve strength, blood sugar control, and cognitive function without frequent travel to a clinic or gym.
How similar studies have performed: Prior home-based and telehealth exercise programs for older adults have shown improvements in physical function and some metabolic or cognitive measures, but direct evidence in people with both long-standing type 2 diabetes and mild cognitive impairment is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch, Galveston — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mandeep Sandhu, PhD, PT — University of Texas Medial Branch
- Study coordinator: Liza Durgens
- Email: lidurgen@utmb.edu
- Phone: (409)772-1011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.