Cognitive and Physical Training in Patients With Chronic Obstructive Pulmonary Disease Patients
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Dmitry Rozenberg, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal