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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Feasibility of a Home-Based Cognitive-Physical Exercise Program in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140226
• Other study ID #: 21-5336
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Dmitry Rozenberg, MD, PhD
• Phone: 416-340-4800
• Email: Dmitry.Rozenberg[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Boehringer Ingelheim, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Behnke M, Taube C, Kirsten D, Lehnigk B, Jorres RA, Magnussen H. Home-based exercise is capable of preserving hospital-based improvements in severe chronic obstructive pulmonary disease. Respir Med. 2000 Dec;94(12):1184-91. doi: 10.1053/rmed.2000.0949. — View Citation

Higbee DH, Dodd JW. Cognitive impairment in COPD: an often overlooked co-morbidity. Expert Rev Respir Med. 2021 Jan;15(1):9-11. doi: 10.1080/17476348.2020.1811090. Epub 2020 Aug 26. No abstract available. — View Citation

Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26. — View Citation

Hung WW, Wisnivesky JP, Siu AL, Ross JS. Cognitive decline among patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Jul 15;180(2):134-7. doi: 10.1164/rccm.200902-0276OC. Epub 2009 May 7. — View Citation

Torres-Sanchez I, Rodriguez-Alzueta E, Cabrera-Martos I, Lopez-Torres I, Moreno-Ramirez MP, Valenza MC. Cognitive impairment in COPD: a systematic review. J Bras Pneumol. 2015 Mar-Apr;41(2):182-90. doi: 10.1590/S1806-37132015000004424. Epub 2015 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Recruitment	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.	Over the study period (8 weeks)
Primary	Participant Retention in the Study	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.	Over the study period (8 weeks)
Primary	Adherence to Physical Training	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.	Over the intervention period (8 weeks)
Primary	Adherence to Cognitive Training	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.	Over the intervention period (8 weeks)
Primary	Safety and Tolerability of Cognitive and Physical Training	Any adverse events with physical training will be assessed throughout the study period.	Over the intervention period (8 weeks)
Primary	Participant Satisfaction with the Cognitive and Physical Training Interventions	A multiple-choice and free-form questionnaire assessing the participants' satisfaction with the cognitive and physical training programs will be completed by study participants.	Change from baseline at weeks 1, 4 and 8
Secondary	Cognitive Function	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.	Baseline
Secondary	Physical Activity Levels	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.	Baseline
Secondary	Demographics Information	A demographic questionnaire will be administered to collect information on age, sex, ethnicity, employment status, education level, and smoking history.	Baseline
Secondary	Dual Task Performance	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.	Change from baseline at 4 and 8 weeks
Secondary	Cognitive Performance	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.	Change from baseline at 4 and 8 weeks
Secondary	Physical Function	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).	Change from baseline at 4 and 8 weeks
Secondary	Aerobic Endurance	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.	Change from baseline at 4 and 8 weeks
Secondary	Severity of Dyspnea	The Medical Research Council (MRC) Dyspnea Scale (scores 1 to 5) will be used to assess the effect of breathlessness on daily activities.	Change from baseline at 4 and 8 weeks
Secondary	Exertional Dyspnea and Leg Fatigue	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.	Change from baseline at 4 and 8 weeks
Secondary	Qualitative Descriptors of Dyspnea	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.	Change from baseline at 4 and 8 weeks
Secondary	Lower Body Strength	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.	Change from baseline at 4 and 8 weeks
Secondary	Physical Activity	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.	7-day intervals at week 1, week 4, and week 8
Secondary	Exercise Training	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.	Daily over the intervention period (8 weeks)
Secondary	Disease Specific Quality of Life	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).	Change from baseline at 4 and 8 weeks
Secondary	Impact of Symptoms on COPD	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.	Change from baseline at 4 and 8 weeks
Secondary	Limitations in Daily Activities	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.	Change from baseline at 4 and 8 weeks
Secondary	Self-Efficacy to Exercise	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).	Change from baseline at 4 and 8 weeks
Secondary	Mood	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.	Change from baseline at 4 and 8 weeks
Secondary	Clinical Characteristics	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.	Over the intervention period (8 weeks) and one year prior to study enrollment
Secondary	Anthropometry	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.	Change from baseline at 4 and 8 weeks
Secondary	Vitals	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.	Change from baseline at 4 and 8 weeks
Secondary	Health Care Utilization	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.	Over the intervention period (8 weeks) and one year prior to study enrollment
Secondary	Presence of Comorbidities	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.	Over the intervention period (8 weeks) and one year prior to study enrollment