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

NCT05140226 | Completed

• 1 other identifier: 21-5336
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Cognitive Training; Physical Training; Randomized Controlled Trial; Home-based Program; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (23)

• Cognitive Function

  Baseline

• Physical Activity Levels

  Baseline

• Demographics Information

  Baseline

• Dual Task Performance

  Change from baseline at 4 and 8 weeks

• Cognitive Performance

  Change from baseline at 4 and 8 weeks

Study Arms (2)

Physical Training (PT)

EXPERIMENTAL

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

Behavioral: Physical Training

Cognitive-Physical Training (C-PT)

EXPERIMENTAL

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

Behavioral: Physical Training; Behavioral: Cognitive-Physical Training

Interventions

Physical Training 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); Physical Training (PT)

Cognitive-Physical Training 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.

Cognitive-Physical Training (C-PT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (6)

• 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.

  PMID: 19423714 BACKGROUND

• 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.

  PMID: 27672116 BACKGROUND

• 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.

  PMID: 11192954 BACKGROUND

• 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.

  PMID: 32811226 BACKGROUND

• 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.

  PMID: 25909154 BACKGROUND

• Rozenberg D, Shore J, Camacho Perez E, Nourouzpour S, Ibrahim Masthan M, Santa Mina D, Campos JL, Huszti E, Green R, Khan MH, Lau A, Gold D, Stanbrook MB, Reid WD. Feasibility of a Home-Based Cognitive-Physical Exercise Program in Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Feasibility and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 12;12:e48666. doi: 10.2196/48666.

  PMID: 37436794 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dmitry Rozenberg, MD PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: March 1, 2022
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)