Recruiting

Resistance Exercise

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07416799

Conditions

Type2diabetes

Mild Cognitive Impairment

Age-related Cognitive Decline

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Progressive Exercise Program (12 Weeks)

Study Details

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

Study ID

NCT07416799

Start date

Apr 14, 2026

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Exercise Program

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.

Interventions

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, questionnaires, blood draw, DEXA scan, and structured interview.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Medical Branch, Galveston

Recruiting

Galveston, Texas, United States, 77555-0133

Contacts

Mandeep Sandhu, PhD,PT

409-772-1011masandhu@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-05-11.