Feasibility of a Home-Based Cognitive-Physical Exercise Program in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adherence to Cognitive Training
研究概览
简要总结
Cognitive and physical function impairments are common in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Research has shown that cognitive and physical exercise training may be a beneficial strategy to improve physical and cognitive performance in COPD patients; however, interventions combining physical and cognitive training have not been evaluated in this population. The objectives of this research are i) to evaluate the feasibility of an 8-week home-based cognitive-physical training program in COPD patients; and ii) to derive preliminary estimates on intervention efficacy with cognitive-physical training on dual-task performance, physical function, activities of daily living, and health-related quality of life. Related to our research objectives, we hypothesize that i) it will be feasible to safely recruit COPD patients into a home-based cognitive physical training program with 75% adherence and high satisfaction ratings with the prescribed training; and that ii) the combination of cognitive and physical training will be superior to physical training alone for improving dual-task and cognitive performance, physical function, activities of daily living, and health-related quality of life.
详细描述
Prospective study of 24 patients diagnosed with moderate to severe COPD recruited from clinics at the University Health Network (Toronto, Canada) and other local community clinics. All study assessments and interventions will be performed remotely from the participants' homes. Participants will be randomly allocated to one of the following groups and stratified by sex: i) Cognitive-Physical Training (C-PT) group: home-based cognitive training (60 minutes, 5 times per week, using the BrainHQ platform) and physical training (5 days of aerobic training and 2 days of strength training per week); ii) Physical Training (PT) group: physical exercise training alone. Study participants will have weekly follow-up video calls with the study team to review training plans. Intervention feasibility will be evaluated through recruitment rate, program adherence, satisfaction, and assessment of adverse events. Efficacy of the intervention will be assessed via cognitive performance tests (BrainHQ), dual-task performance test (i.e., spelling backwards while peddling), physical fitness assessments (i.e., lower body strength, aerobic endurance, and physical function), physical activity levels (i.e., Fitbit, physical activity questionnaire), self-reported measures of dyspnea, health-related quality of life, activities of daily living, exercise self-efficacy, and mood. Participants will have repeat assessments after 4 and 8 weeks.
Training to improve cognitive performance has shown to be successful in adults with different neurologic conditions, but has not been evaluated in COPD. The assessment of feasibility and effect estimates of home-based cognitive-physical training will serve as an important catalyst in the development of future clinical trials aimed at reducing the morbidity associated with cognitive and physical impairments in COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (≥ 50 years of age)
- •Clinical and spirometric diagnosis of COPD (FEV1 30-80%)
- •Access to reliable internet connection
- •Ability to mobilize independently and safely, with or without a walking aid
排除标准
- •Current participation in a pulmonary rehabilitation program
- •Disease exacerbation in the past 3 months
- •Diagnosis of a neurological or musculoskeletal condition that would interfere with safe performance of study tests (e.g., stroke, myopathy, inflammatory arthritis)
- •Severe cognitive impairment ascertained by chart review or self-reported
- •Coronary artery disease, pacemaker or implantable defibrillator, clinical diagnosis of congestive heart failure (CHF), or poorly controlled arrhythmias
- •Medical instability (hepatic dysfunction, metabolic abnormalities, or active infection)
- •Overt psychiatric disorder or substance abuse
- •Patient on home oxygen therapy
- •Insufficient English fluency and cognition to carry out testing and training
- •Patient actively listed for lung transplantation
研究组 & 干预措施
Physical Training (PT)
Participants in the PT group will perform eight weeks of home-based physical exercise training.
干预措施: Physical Training (Behavioral)
Cognitive-Physical Training (C-PT)
Participants in the C-PT will perform eight weeks of home-based cognitive and physical training.
干预措施: Physical Training (Behavioral)
Cognitive-Physical Training (C-PT)
Participants in the C-PT will perform eight weeks of home-based cognitive and physical training.
干预措施: Cognitive-Physical Training (Behavioral)
结局指标
主要结局
Adherence to Cognitive Training
时间窗: Over the intervention period (8 weeks)
Adherence to the cognitive training intervention will be expressed as i) the number of cognitive training days completed out of the total number of cognitive training days prescribed, and ii) the number of cognitive training levels and minutes completed out of the number of levels and minutes prescribed using the Brain HQ platform. Adherence to the cognitive training of 75% or greater has been established as our criteria to determine study feasibility.
Participant Retention in the Study
时间窗: Over the study period (8 weeks)
Participant retention will be assessed by measuring participant follow-up with testing throughout the study period. A retention rate of 80% or greater (in each group) has been established as our criteria to determine study feasibility.
Adherence to Physical Training
时间窗: Over the intervention period (8 weeks)
Adherence to the exercise training intervention will be expressed as the percentage of physical exercise activities/training days completed out of the total number of activities/training days prescribed. Adherence to the exercise intervention of 75% or greater has been established as our criteria to determine feasibility for future projects.
Participant Satisfaction with the Cognitive and Physical Training Interventions
时间窗: Change from baseline at weeks 1, 4 and 8
A multiple-choice and free-form questionnaire assessing the participants' satisfaction with the cognitive and physical training programs will be completed by study participants.
Study Recruitment
时间窗: Over the study period (8 weeks)
Recruitment-success percentage and reasons for participation/non-participation in the study will be collected. A consent rate of 30% or greater has been established as our criteria to determine study feasibility for future projects.
Safety and Tolerability of Cognitive and Physical Training
时间窗: Over the intervention period (8 weeks)
Any adverse events with physical training will be assessed throughout the study period.
次要结局
- Physical Activity(7-day intervals at week 1, week 4, and week 8)
- Cognitive Function(Baseline)
- Aerobic Endurance(Change from baseline at 4 and 8 weeks)
- Severity of Dyspnea(Change from baseline at 4 and 8 weeks)
- Physical Activity Levels(Baseline)
- Dual Task Performance(Change from baseline at 4 and 8 weeks)
- Physical Function(Change from baseline at 4 and 8 weeks)
- Lower Body Strength(Change from baseline at 4 and 8 weeks)
- Demographics Information(Baseline)
- Cognitive Performance(Change from baseline at 4 and 8 weeks)
- Exertional Dyspnea and Leg Fatigue(Change from baseline at 4 and 8 weeks)
- Qualitative Descriptors of Dyspnea(Change from baseline at 4 and 8 weeks)
- Impact of Symptoms on COPD(Change from baseline at 4 and 8 weeks)
- Anthropometry(Change from baseline at 4 and 8 weeks)
- Exercise Training(Daily over the intervention period (8 weeks))
- Disease Specific Quality of Life(Change from baseline at 4 and 8 weeks)
- Limitations in Daily Activities(Change from baseline at 4 and 8 weeks)
- Mood(Change from baseline at 4 and 8 weeks)
- Vitals(Change from baseline at 4 and 8 weeks)
- Health Care Utilization(Over the intervention period (8 weeks) and one year prior to study enrollment)
- Presence of Comorbidities(Over the intervention period (8 weeks) and one year prior to study enrollment)
- Self-Efficacy to Exercise(Change from baseline at 4 and 8 weeks)
- Clinical Characteristics(Over the intervention period (8 weeks) and one year prior to study enrollment)