RecruitingNot ApplicableNCT07416799

Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment


Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

20 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria14

  • 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

Interventions

OTHERProgressive Exercise Program (12 Weeks)

12-week exercise program with gradual transition from supervised to independent sessions. Participants complete 50-minute sessions, 3 times/week, including: Warm-up (10 min) Resistance training (35 min): upper arm exercises, wall push-ups, biceps curls, side bends, squats, glute bridges, hip abduction Cool-down (5 min) Supervision: Weeks 1-2: Mostly supervised Weeks 5-8: Mixed Weeks 9-12: Mostly unsupervised with Zoom/Teams support Weekly staff check-ins. Week 13: Repeat baseline tests, questionnaires, blood draw, DEXA scan, and structured interview.


Locations(1)

University of Texas Medical Branch, Galveston

Galveston, Texas, United States

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NCT07416799


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