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

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.

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

Interventions

• 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, ques

Primary outcome measures

• Feasibility of Technology-Assisted Home-Based Exercise Program [Time frame: Week 13 (end of intervention and final assessment)]
• Acceptability of Technology-Assisted Home-Based Exercise Program [Time frame: Week 13 (end of intervention and final assessment)]

Secondary outcome measures (8)

• Change in Balance Performance From Baseline to Week 13 [Time frame: Baseline and Week 13]
• Change in Cognitive Function using Montreal Cognitive Assessment (MoCA) [Time frame: Baseline and Week 13]
• Change in Cognitive Function (PROMIS Cognitive Function) [Time frame: Baseline and Week 13]
• Change in Timed Up and Go (TUG) Test Time From Baseline to Week 13 [Time frame: Baseline and Week 13]
• Change in Glycemic Control [Time frame: Baseline and Week 13]
• Change in Hand Grip Strength From Baseline to Week 13 [Time frame: Baseline and Week 13]
• Change in Six-Minute Walk Test Distance From Baseline to Week 13 [Time frame: Baseline and Week 13]
• Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to Week 13 [Time frame: Baseline and Week 13]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Texas Medical Branch, Galveston — Galveston

Identifiers

NCT: NCT07416799 · 25-0195

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗