Clinical trial NCT05140226: Cognitive and Physical Training in Patients with Chronic Obstructive Pulmonary Disease Patients
Official title: Feasibility of a Home-Based Cognitive-Physical Exercise Program in Chronic Obstructive Pulmonary Disease (COPD) Patients: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Cognitive Training
Physical Training
Randomized Controlled Trial
Home-based Program
Chronic Obstructive Pulmonary Disease
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Boehringer Ingelheim
First posted: 2021-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Recruitment
timeFrame: Over the study period (8 weeks)
measure: Participant Retention in the Study
timeFrame: Over the study period (8 weeks)
measure: Adherence to Physical Training
timeFrame: Over the intervention period (8 weeks)
measure: Adherence to Cognitive Training
timeFrame: Over the intervention period (8 weeks)
measure: Safety and Tolerability of Cognitive and Physical Training
timeFrame: Over the intervention period (8 weeks)
measure: Participant Satisfaction with the Cognitive and Physical Training Interventions
timeFrame: Change from baseline at weeks 1, 4 and 8
Secondary outcomes:
measure: Cognitive Function
timeFrame: Baseline
measure: Physical Activity Levels
timeFrame: Baseline
measure: Demographics Information
timeFrame: Baseline
measure: Dual Task Performance
timeFrame: Change from baseline at 4 and 8 weeks
measure: Cognitive Performance
timeFrame: Change from baseline at 4 and 8 weeks
measure: Physical Function
timeFrame: Change from baseline at 4 and 8 weeks
measure: Aerobic Endurance
timeFrame: Change from baseline at 4 and 8 weeks
measure: Severity of Dyspnea
timeFrame: Change from baseline at 4 and 8 weeks
measure: Exertional Dyspnea and Leg Fatigue
timeFrame: Change from baseline at 4 and 8 weeks
measure: Qualitative Descriptors of Dyspnea
timeFrame: Change from baseline at 4 and 8 weeks
measure: Lower Body Strength
timeFrame: Change from baseline at 4 and 8 weeks
measure: Physical Activity
timeFrame: 7-day intervals at week 1, week 4, and week 8
measure: Exercise Training
timeFrame: Daily over the intervention period (8 weeks)
measure: Disease Specific Quality of Life
timeFrame: Change from baseline at 4 and 8 weeks
measure: Impact of Symptoms on COPD
timeFrame: Change from baseline at 4 and 8 weeks
measure: Limitations in Daily Activities
timeFrame: Change from baseline at 4 and 8 weeks
measure: Self-Efficacy to Exercise
timeFrame: Change from baseline at 4 and 8 weeks
measure: Mood
timeFrame: Change from baseline at 4 and 8 weeks
measure: Clinical Characteristics
timeFrame: Over the intervention period (8 weeks) and one year prior to study enrollment
measure: Anthropometry
timeFrame: Change from baseline at 4 and 8 weeks
measure: Vitals
timeFrame: Change from baseline at 4 and 8 weeks
measure: Health Care Utilization
timeFrame: Over the intervention period (8 weeks) and one year prior to study enrollment
measure: Presence of Comorbidities
timeFrame: Over the intervention period (8 weeks) and one year prior to study enrollment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dmitry Rozenberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.