Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
Recruiting · NCT07416799 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Medical Branch, Galveston
View the official record on ClinicalTrials.gov →Interventions studied
Progressive Exercise Program (12 Weeks)
What this trial is about
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.
Who can take part
Age range
55 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age: 55-80 years
- Diabetes: Diagnosed T2DM with ≥5 years duration
- Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
- Medication Stability: Stable medication regimen for at least 3 months
- Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)
- Support System: Having a caregiver or support person willing to assist with technology use if needed
Exclusion criteria
- Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease
- Diagnosis of Alzheimer's disease,
- 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.
- Significant cerebral vascular disease
- 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),
- Visual/hearing impairment that would significantly impact the ability to participate in psychometric testing.
- Significant medical illness or organ failure, including hepatic or renal failure, unstable cardiac disease,
- Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable).
- Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable).
- Stage 5 renal impairment (GFR less than 15 or dialysis).
- Participation in another clinical trial.
- Prisoners.
- 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.
- Lack of Support: No available caregiver or support person for technology assistance
Where it is running
1 location listed across 1 US state.
- University of Texas Medical Branch, Galveston - Galveston, Texas, United States