Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks."
- "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"
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adults ages 55–80 with type 2 diabetes and mild memory or thinking problems can take part in and stick with a 12-week home strength training program. The program uses remote health support and moves from supervised exercise sessions to sessions done without supervision.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 55–80 years old.
- You have had type 2 diabetes for at least 5 years.
- You have mild memory or thinking problems that meet the study’s rules, with a Montreal Cognitive Assessment (MoCA) test score of 18–25.
- Your medicines have stayed the same for at least 3 months.
- You can do moderate exercise, and a doctor has cleared you to take part.
- You have a caregiver or support person willing to help with technology if needed.
Who can't join
- You have a movement disorder, such as multiple sclerosis or Parkinson’s disease; Alzheimer’s disease; or serious disease of the blood vessels in the brain.
- You have severe depression, a major mental health condition, or alcoholism that could make it hard to understand or follow the study.
- You take medicines that may strongly affect memory, thinking, or certain nerve signals. These include some medicines for mental health, seizures, sleep, or anxiety, and steroids used often or long-term.
- You have vision or hearing problems that would make it very hard to take the study’s mental skills tests.
- You have a serious illness or organ failure, including liver or kidney failure or unstable heart disease. This includes stage 5 kidney disease, a kidney filtering rate below 15, or dialysis.
- You have untreated low vitamin B12 or an underactive thyroid, or uncontrolled blood pressure above 160 for the top number or 100 for the bottom number. Stable treatment is allowed; B12 or thyroid treatment must be stable for at least 3 months.
- You have a condition that makes moderate exercise unsafe, such as severe narrowing of the heart’s aortic valve, poorly controlled blood pressure, heart-related chest pain, or fainting.
- You are in another clinical trial, are a prisoner, or have no caregiver or support person available to help with technology.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
TX
- University of Texas Medical Branch, Galveston · Galveston, TX 77555-0133Mandeep Sandhu, PhD,PT · Study contact · 409-772-1011 · masandhu@utmb.eduMore trials in Galveston