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

Not Applicable

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Behavioral: Physical Training; Behavioral: Cognitive-Physical Training

• Registration Number: NCT05140226
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-12-01
• Study Start: 2022-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Physical Training (C-PT)	Cognitive-Physical Training	Participants in the C-PT will perform eight weeks of home-based cognitive and physical training.
Physical Training (PT)	Physical Training	Participants in the PT group will perform eight weeks of home-based physical exercise training.
Cognitive-Physical Training (C-PT)	Physical Training	Participants in the C-PT will perform eight weeks of home-based cognitive and physical training.

Primary Outcome Measures

Name	Time	Method
Study Recruitment	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.
Adherence to Cognitive Training	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	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	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	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.
Safety and Tolerability of Cognitive and Physical Training	Over the intervention period (8 weeks)	Any adverse events with physical training will be assessed throughout the study period.

Secondary Outcome Measures

Name	Time	Method
Cognitive Function	Baseline	The Montreal Cognitive Assessment (MoCA) will be used to screen for cognitive impairment, specifically short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The MoCA will be administered at the baseline assessment only to help characterize our study population and it takes around 10 minutes to be completed.
Aerobic Endurance	Change from baseline at 4 and 8 weeks	Aerobic endurance will be measured via a foot peddler test developed by our research group. Participants will be instructed to sit on a standard chair and to pedal at a self-selected speed for 2 minutes. After warming up, participants will continue pedaling at 50 revolutions per minute at a Borg Exertion intensity of 4. Participants will be instructed to continue pedaling for as long as they are able to maintain the current exertional intensity.
Severity of Dyspnea	Change from baseline at 4 and 8 weeks	The Medical Research Council (MRC) Dyspnea Scale (scores 1 to 5) will be used to assess the effect of breathlessness on daily activities.
Physical Activity Levels	Baseline	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to measure physical activity levels in study participants. The questionnaire consists of seven questions to capture average daily time spent sitting, walking, and engaging in moderate and vigorous physical activity over the last seven days. The IPAQ-SF provides an overall physical activity level of participants based on their Metabolic Equivalent Task minutes (MET-min) per week.
Dual Task Performance	Change from baseline at 4 and 8 weeks	Study participants will be asked to complete two single tasks and a dual-task: i) spelling backwards: spelling five letter words backwards from a list of 100 words for one minute; ii) motor task: pedaling on a foot peddler for 1 minute at a set speed of 50 RPM and at a self-selected resistance that will allow participants to hold a conversation; iii) dual-task: pedaling for 1 minute at a speed targeting 50 RPM while spelling five letter words backwards from a list of 100 words.
Physical Function	Change from baseline at 4 and 8 weeks	The short physical performance battery (SPPB) will be used to assess balance, gait, lower extremity strength, and endurance. This assessment evaluates the participants' ability to stand with their feet together in several positions (side-by-side, semi-tandem, and tandem), walking speed over 4 meters, and chair stands (time to rise from a chair and return to the seated position five times).
Lower Body Strength	Change from baseline at 4 and 8 weeks	The one-minute sit-to-stand test (1-STS) will be performed to evaluate lower body strength using a standard chair (46 cm). Participants will stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. Participants will be instructed to indicate their Borg Dyspnea and Borg Leg Exertion scores before and after the test.
Demographics Information	Baseline	A demographic questionnaire will be administered to collect information on age, sex, ethnicity, employment status, education level, and smoking history.
Cognitive Performance	Change from baseline at 4 and 8 weeks	Participants will have their progress evaluated with cognitive training using the BrainHQ platform. BrainHQ assessments measure how the participants' performance changes and evaluate the success of the cognitive training program. Testing assignments will be personalized by using the Personal Trainer option and will have a focus on evaluating sustained attention, executive function, short and long-term memory, and anxiety and depression.
Exertional Dyspnea and Leg Fatigue	Change from baseline at 4 and 8 weeks	The highest score on a 10-point Borg Dyspnea scale at the start and end of the Aerobic Endurance (foot peddler) test will be the primary dyspnea and leg fatigue measure.
Qualitative Descriptors of Dyspnea	Change from baseline at 4 and 8 weeks	The 18-point Qualitative Dyspnea Scale will be ascertained at baseline and at the end of the Aerobic Endurance (foot peddler) test from a list of 18 descriptors.
Physical Activity	7-day intervals at week 1, week 4, and week 8	Physical activity will be measured via an activity tracker (Fitbit, San Francisco, USA) which will record daily activity levels (minutes and steps) of the study participants.
Impact of Symptoms on COPD	Change from baseline at 4 and 8 weeks	The COPD Assessment Test (CAT) will be implemented to assess cough, production of phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep, and energy. The CAT consists of eight items, each formatted as a six-point differential scale and with an overall score ranging from 0 to 40.
Anthropometry	Change from baseline at 4 and 8 weeks	Participants will be asked to provide data on their body weight if they have access to a weight scale at home. Otherwise, the values from their most recent pulmonary function testing will be abstracted.
Exercise Training	Daily over the intervention period (8 weeks)	Exercise behaviours of the study participants will be collected via a self-reported exercise log. These logs will comprise of sections in which participants must describe the type of exercise, duration/repetitions, and intensity.
Disease Specific Quality of Life	Change from baseline at 4 and 8 weeks	The St. George's Respiratory Questionnaire will be administered to measure the impact of COPD on overall health, daily life, and perceived well-being in our cohort. The questionnaire is composed of 50 items with scores ranging from 0 to 100 (higher scores indicate more limitations).
Limitations in Daily Activities	Change from baseline at 4 and 8 weeks	The London Chest Activities of Daily Living Questionnaire will be administered to assess the limitations in performing activities of daily living as a consequence of dyspnea. It is composed of 4 domains: self-care, domestic activities, physical activities, and leisure.
Mood	Change from baseline at 4 and 8 weeks	The Depression, Anxiety and Stress Scale (DASS-21) questionnaire has 21 items to assess mood (anxiety, depression, and stress). There are three self-report scales designed to measure the emotional states of depression, anxiety and stress with each question ranging from a score of 0 (did not apply) to 3 (applied most of the time). Scores for each domain (depression, anxiety, and stress) will be categorized as follows: Normal, Mild, Moderate, Severe, and Extremely Severe.
Vitals	Change from baseline at 4 and 8 weeks	Participants will be asked to provide data on their blood pressure if they have access to a blood pressure monitor. Oxygen saturation and heart rate will be measured via a pulse oximeter.
Health Care Utilization	Over the intervention period (8 weeks) and one year prior to study enrollment	Information on health care utilization (i.e., exacerbations, use of steroid/antibiotics, mortality, admissions to hospital, history of falls, and emergency department visits) will be collected with a self-reported questionnaire administered to participants and through chart review.
Presence of Comorbidities	Over the intervention period (8 weeks) and one year prior to study enrollment	The presence of comorbidities in our study participants will be ascertained using the Charlson Comorbidity Index and through chart review using a comprehensive comorbidity questionnaire developed by our team.
Self-Efficacy to Exercise	Change from baseline at 4 and 8 weeks	The Exercise Self-Regulatory Efficacy Scale (Ex-SRES) will be administered to measure exercise self-regulatory efficacy. The Ex-SRES is composed of 16 items asking participants to indicate the degree to which they are confident they could continue to exercise regularly when faced with different barriers. Participants will have to indicate their confidence level from 0% (not at all confident) to 100% (highly confident).
Clinical Characteristics	Over the intervention period (8 weeks) and one year prior to study enrollment	Clinical characteristics including forced expiratory volume in the first second (FEV1), medications (e.g., opioids, prednisone), baseline 6-minute walk distance, body mass index, airway obstruction, dyspnea, and exercise capacity (BODE) index, and exacerbation history will be ascertained from chart review.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada