Technology-assisted home strength training for adults 55–80 with type 2 diabetes and mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.