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NCT Number: NCT07416799

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

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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555-0133, United States

Location status: Recruiting

Location contact

Mandeep Sandhu, PhD,PT

CONTACT

[email protected]

409-772-1011

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Technology-Assisted Home-Based Exercise Program

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

    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.

  2. Acceptability of Technology-Assisted Home-Based Exercise Program

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

    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.

Secondary outcomes

  1. Change in Balance Performance From Baseline to Week 13

    Time frame: Baseline and 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.

  2. Change in Cognitive Function using Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline and Week 13

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

  3. Change in Cognitive Function (PROMIS Cognitive Function)

    Time frame: Baseline and Week 13

    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.

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

    Time frame: Baseline and 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.

  5. Change in Glycemic Control

    Time frame: Baseline and Week 13

    Assessed by changes in HbA1C levels to evaluate the metabolic impact of the exercise intervention.

  6. Change in Hand Grip Strength From Baseline to Week 13

    Time frame: Baseline and Week 13

    Hand grip strength will be measured using a calibrated hand dynamometer. Grip strength is recorded in kilograms (kg). Change in grip strength will be calculated as the difference between baseline and Week 13 measurements. Higher values indicate greater muscle strength and better physical function.

  7. Change in Six-Minute Walk Test Distance From Baseline to Week 13

    Time frame: Baseline and Week 13

    Functional exercise capacity will be assessed using the Six-Minute Walk Test. Total distance walked in six minutes is recorded in meters. Change will be calculated as the difference between baseline and Week 13 distance walked. Greater walking distance indicates better physical endurance and functional capacity.

  8. Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to Week 13

    Time frame: Baseline and Week 13

    Functional independence will be assessed using an Instrumental Activities of Daily Living (IADL) assessment. Scores are reported according to the instrument scoring system, with higher scores indicating greater functional independence. Change is calculated as the difference between baseline and Week 13 scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Liza Durgens

CONTACT

[email protected]

(409)772-1011

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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