Age-related Cognitive Decline, Mild Cognitive Impairment, Type2diabetes
Conditions
Keywords
Home-Based exercise, Type 2 Diabetes Mellitus (T2DM), Mild cognitive impairment (MCI), Ages 55-80
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.
Detailed description
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
Interventions
OTHERProgressive 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Technology-Assisted Home-Based Exercise Program | 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. |
| Acceptability of Technology-Assisted Home-Based Exercise Program | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Balance Performance From Baseline to Week 13 | 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. |
| Change in Cognitive Function using Montreal Cognitive Assessment (MoCA) | Baseline and Week 13 | Measured using Montreal Cognitive Assessment (MoCA) scores to detect improvements in executive function and memory. |
| Change in Cognitive Function (PROMIS Cognitive Function) | 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. |
| Change in Timed Up and Go (TUG) Test Time From Baseline to Week 13 | 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. |
| Change in Glycemic Control | Baseline and Week 13 | Assessed by changes in HbA1C levels to evaluate the metabolic impact of the exercise intervention. |
| Change in Hand Grip Strength From Baseline to Week 13 | 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. |
| Change in Six-Minute Walk Test Distance From Baseline to Week 13 | 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. |
| Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to Week 13 | 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. |
Countries
United States
Contacts
CONTACTLiza Durgens
PRINCIPAL_INVESTIGATORMandeep Sandhu, PhD, PT
University of Texas Medial Branch
Outcome results
None listed