NCT07416799 Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
| NCT ID | NCT07416799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-04-14 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Mandeep Sandhu, PhD, PT
PRINCIPAL INVESTIGATOR
University of Texas Medial Branch
Frequently Asked Questions
Who can join the NCT07416799 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Type2diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07416799 currently recruiting?
Yes, NCT07416799 is actively recruiting participants. Contact the research team at lidurgen@utmb.edu for enrollment information.
Where is the NCT07416799 trial being conducted?
This trial is being conducted at Galveston, United States.
Who is sponsoring the NCT07416799 clinical trial?
NCT07416799 is sponsored by The University of Texas Medical Branch, Galveston. The principal investigator is Mandeep Sandhu, PhD, PT at University of Texas Medial Branch. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.