Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Technology-Assisted Home-Based Exercise Program
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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
研究组 & 干预措施
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.
干预措施: Progressive Exercise Program (12 Weeks) (Other)
结局指标
主要结局
Feasibility of Technology-Assisted Home-Based Exercise Program
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change in Hand Grip Strength From Baseline to Week 13(Baseline and Week 13)
- Change in Six-Minute Walk Test Distance From Baseline to Week 13(Baseline and Week 13)
- Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to Week 13(Baseline and Week 13)