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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Progressive Exercise Program (12 Weeks)

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Exercise ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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

1

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.

Time frame
Baseline and Week 13
2

Change in Cognitive Function using Montreal Cognitive Assessment (MoCA)

Measured using Montreal Cognitive Assessment (MoCA) scores to detect improvements in executive function and memory.

Time frame
Baseline and Week 13
3

Change in Cognitive Function (PROMIS Cognitive Function)

Cognitive function will be assessed using the PROMIS® Cognitive Function measure. Scores are reported as T-scores with higher scores indicating better cognitive function. Change is calculated as the difference between baseline and Week 13 T-scores.

Time frame
Baseline and Week 13
4

Change in Timed Up and Go (TUG) Test Time From Baseline to Week 13

Functional mobility will be assessed using the Timed Up and Go (TUG) test. Time to complete the task is recorded in seconds, with lower times indicating better functional mobility. Change is calculated as the difference between baseline and Week 13 TUG times.

Time frame
Baseline and Week 13

Other outcomes

Sponsors and contacts

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