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

NCT07416799 | Recruiting

• 1 other identifier: 25-0195
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Type2diabetes; Mild Cognitive Impairment; Age-related Cognitive Decline

Keywords

Home-Based exercise; Type 2 Diabetes Mellitus (T2DM); Mild cognitive impairment (MCI); Ages 55-80

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 13 (end of intervention and final assessment)

Secondary Outcomes (8)

• Change in Balance Performance From Baseline to Week 13

  Baseline and Week 13

• Change in Cognitive Function using Montreal Cognitive Assessment (MoCA)

  Baseline and Week 13

• Change in Cognitive Function (PROMIS Cognitive Function)

  Baseline and Week 13

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

  Baseline and Week 13

• Change in Glycemic Control

  Baseline and Week 13

Study Arms (1)

Exercise Program

EXPERIMENTAL

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)

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.

Exercise Program

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555-0133, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mandeep Sandhu, PhD, PT

  University of Texas Medial Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liza Durgens

CONTACT

(409)772-1011; lidurgen@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)