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

The University of Texas Medical Branch, Galveston20 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type2diabetes

Interventions

Progressive Exercise Program (12 Weeks)OTHER

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of Technology-Assisted Home-Based Exercise Program

Feasibility will be assessed as the proportion of enrolled participants who complete the full 12-week home-based exercise intervention. The completion rate is calculated as the number of participants who complete the intervention divided by the total number of enrolled participants, expressed as a percentage (0% to 100%). A completion rate of ≥80% is considered indicative of acceptable feasibility.

Time frame: Week 13 (end of intervention and final assessment)

Acceptability of Technology-Assisted Home-Based Exercise Program

Acceptability will be evaluated using exercise adherence, defined as the percentage of prescribed exercise sessions completed during the 12-week intervention period. Adherence will be calculated using data collected from technology monitoring systems and participant self-report logs. Adherence values range from 0% to 100%, with ≥70% adherence considered acceptable.

Time frame: Week 13 (end of intervention and final assessment)

Secondary Outcomes

Change in Balance Performance From Baseline to Week 13

Balance will be assessed using a standardized clinical balance assessment. Balance performance will be recorded according to the scoring method of the assessment tool used. Change will be calculated as the difference between baseline and Week 13 scores. Higher scores indicate better balance performance.