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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 55 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Exercise Program 		Participants will complete a 12-week progressive exercise program with 50-minute sessions three times per week, including warm-up, resistance training, and cool-down. Supervision transitions from primarily in-person (Weeks 1-2) to mixed (Weeks 5-8) and mostly unsupervised with virtual support (Weeks 9-12). Weekly check-ins are provided, and a final assessment occurs at Week 13.
  • Other: Progressive 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.

Recruiting Locations

University of Texas Medical Branch, Galveston
Galveston 4692883, Texas 4736286 77555-0133
Contact:
Mandeep Sandhu, PhD,PT
409-772-1011
masandhu@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Liza Durgens
(409)772-1011
lidurgen@utmb.edu

Detailed Description

The prevalence of T2DM and cognitive impairment increases with age, and these conditions often co-occur, creating compounded health challenges. Physical activity has been shown to benefit both glucose control and cognitive function in older adults. However, traditional supervised exercise programs face barriers, including transportation difficulties, scheduling conflicts, and concerns about exercising in group settings, which are particularly relevant for individuals with cognitive impairment. Telehealth home-based programs offer a promising solution by providing structured guidance while allowing participants to exercise in familiar environments. The combination of initial supervision transitioning to independent practice addresses both safety concerns and the goal of sustainable behavior change. Objective: - Evaluate the feasibility of implementing a 12-week technology-assisted home-based physical activity program - Assess adherence rates to the prescribed exercise regimen - Examine changes in physical function, cognitive function, and glycemic control - Identify barriers and facilitators to program engagement through qualitative interviews

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.