Cognitive and Physical Training in Patients With Chronic Obstructive Pulmonary Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)

NCT01349608

Chronic Obstructive Pulmonary Disease Physical Activity Health Behavior

COMPLETED NA

Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

NCT02860728

Chronic Obstructive Pulmonary Disease

COMPLETED NA

The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease

NCT02050945

COPD Exercise Resistance Training

COMPLETED NA

Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients

NCT02999685

Chronic Obstructive Pulmonary Disease Emphysema Pulmonary Rehabilitation

COMPLETED NA

Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training

NCT01135966

COPD

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physical Training (PT)

Participants in the PT group will perform eight weeks of home-based physical exercise training.

Group Type EXPERIMENTAL

Physical Training

Intervention Type BEHAVIORAL

Eight weeks of home-based physical exercise training. Aerobic training will be performed 5 times per week using a foot peddler for a minimum of 30 minutes at a moderate intensity (Borg Exertion Scale: between 4 and 6; pedaling speed: 50 RPM). Strength training will be performed 2 times per week, with 1-3 sets of 10-12 repetitions per exercise. Strength exercises will include training with resistance bands and bodyweight exercises. Participants will be instructed to reduce the intensity of their training if they reach a score of 7 on the Borg Exertion Scale, if oxygen saturation is less than 85%, or if they experience any symptoms. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials.

Cognitive-Physical Training (C-PT)

Participants in the C-PT will perform eight weeks of home-based cognitive and physical training.

Group Type EXPERIMENTAL

Physical Training

Intervention Type BEHAVIORAL

Eight weeks of home-based physical exercise training. Aerobic training will be performed 5 times per week using a foot peddler for a minimum of 30 minutes at a moderate intensity (Borg Exertion Scale: between 4 and 6; pedaling speed: 50 RPM). Strength training will be performed 2 times per week, with 1-3 sets of 10-12 repetitions per exercise. Strength exercises will include training with resistance bands and bodyweight exercises. Participants will be instructed to reduce the intensity of their training if they reach a score of 7 on the Borg Exertion Scale, if oxygen saturation is less than 85%, or if they experience any symptoms. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials.

Cognitive-Physical Training

Intervention Type BEHAVIORAL

Eight weeks of home-based cognitive and physical training. Cognitive training sessions will be performed 5 times per week using the Brain HQ platform (Posit Science; San Francisco, CA, USA) and will have a duration of approximately 60 minutes. The cognitive training program will be tailored by using the Personal Trainer function which presents an automated sequence of exercise levels to participants based on selected exercises. Participants will have identical sessions initially, but schedules will diverge as participants progress and as the algorithm considers their individual performance history. The Personal Trainer program will be customized to the abilities of each user and will include a focus on the following domains: sustained attention, executive function, short and long-term memory, and anxiety and depression. Participants in this group will also engage in the same exercise training intervention as participants in the Physical Training group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Training

Eight weeks of home-based physical exercise training. Aerobic training will be performed 5 times per week using a foot peddler for a minimum of 30 minutes at a moderate intensity (Borg Exertion Scale: between 4 and 6; pedaling speed: 50 RPM). Strength training will be performed 2 times per week, with 1-3 sets of 10-12 repetitions per exercise. Strength exercises will include training with resistance bands and bodyweight exercises. Participants will be instructed to reduce the intensity of their training if they reach a score of 7 on the Borg Exertion Scale, if oxygen saturation is less than 85%, or if they experience any symptoms. Exercise prescriptions will be developed and monitored by an exercise professional with weekly follow-up meetings and supported with a web application (Physiotec) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials.

Intervention Type BEHAVIORAL

Cognitive-Physical Training

Eight weeks of home-based cognitive and physical training. Cognitive training sessions will be performed 5 times per week using the Brain HQ platform (Posit Science; San Francisco, CA, USA) and will have a duration of approximately 60 minutes. The cognitive training program will be tailored by using the Personal Trainer function which presents an automated sequence of exercise levels to participants based on selected exercises. Participants will have identical sessions initially, but schedules will diverge as participants progress and as the algorithm considers their individual performance history. The Personal Trainer program will be customized to the abilities of each user and will include a focus on the following domains: sustained attention, executive function, short and long-term memory, and anxiety and depression. Participants in this group will also engage in the same exercise training intervention as participants in the Physical Training group.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No