Study Summary
This trial will test the feasibility of an 8-week home-based cognitive-physical training program for COPD patients, as well as the efficacy of the program in improving physical and cognitive performance.
Eligible Conditions
- Airflow Obstruction, Chronic
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 23 Secondary · Reporting Duration: Over the intervention period (8 weeks) and one year prior to study enrollment
Week 8
Physical Activity
Baseline
Cognitive Function
Demographics Information
Physical Activity Levels
Week 8
Aerobic Endurance
Anthropometry
Cognitive Performance
Disease Specific Quality of Life
Dual Task Performance
Exertional Dyspnea and Leg Fatigue
Impact of Symptoms on COPD
Limitations in Daily Activities
Lower Body Strength
Mood
Physical Function
Qualitative Descriptors of Dyspnea
Self-Efficacy to Exercise
Severity of Dyspnea
Vitals
Week 1
Participant Satisfaction with the Cognitive and Physical Training Interventions
Week 8
Exercise Training
Week 8
Adherence to Cognitive Training
Adherence to Physical Training
Safety and Tolerability of Cognitive and Physical Training
Week 8
Clinical Characteristics
Health Care Utilization
Presence of Comorbidities
Week 8
Participant Retention in the Study
Study Recruitment
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Cognitive-Physical Training (C-PT)
1 of 2
Physical Training (PT)
1 of 2
Experimental Treatment
24 Total Participants · 2 Treatment Groups
Primary Treatment: Cognitive-Physical Training · No Placebo Group · N/A
Cognitive-Physical Training (C-PT)Experimental Group · 2 Interventions: Cognitive-Physical Training, Physical Training · Intervention Types: Behavioral, Behavioral
Physical Training (PT)
Behavioral
Experimental Group · 1 Intervention: Physical Training · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Training
2016
N/A
~710
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over the intervention period (8 weeks) and one year prior to study enrollment
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,370 Previous Clinical Trials
471,848 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,223 Previous Clinical Trials
24,403,709 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,377 Previous Clinical Trials
9,769,945 Total Patients Enrolled
Dmitry Rozenberg, MD PhDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
40 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a clinical and spirometric diagnosis of COPD (FEV1 30-80%).
About The Reviewer
Michael Gill - B. Sc.
First Published: October 25th, 2021
Last Reviewed: November 3rd, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| West Virginia | 50.0% |
| Florida | 25.0% |
| Connecticut | 25.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Holland, Anne E, Ajay Mahal, Catherine J Hill, Annemarie L Lee, Angela T Burge, Narelle S Cox, Rosemary Moore, et al.. 2016. “Home-based Rehabilitation for COPD Using Minimal Resources: A Randomised, Controlled Equivalence Trial”. Thorax. BMJ. doi:10.1136/thoraxjnl-2016-208514.
- Higbee, Daniel H., and James W. Dodd. 2020. “Cognitive Impairment in COPD: An Often Overlooked Co-morbidity”. Expert Review of Respiratory Medicine. Informa UK Limited. doi:10.1080/17476348.2020.1811090.
- Hung, William W., Juan P. Wisnivesky, Albert L. Siu, and Joseph S. Ross. 2009. “Cognitive Decline Among Patients with Chronic Obstructive Pulmonary Disease”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.200902-0276oc.
- Torres-Sánchez, Irene, Elisabeth Rodríguez-Alzueta, Irene Cabrera-Martos, Isabel López-Torres, Maria Paz Moreno-Ramírez, and Marie Carmen Valenza. 2015. “Cognitive Impairment in COPD: A Systematic Review”. Jornal Brasileiro De Pneumologia. FapUNIFESP (SciELO). doi:10.1590/s1806-37132015000004424.
- BEHNKE, M, C TAUBE, D KIRSTEN, B LEHNIGK, R.A JÖRRES, and H MAGNUSSEN. 2000. “Home-based Exercise Is Capable of Preserving Hospital-based Improvements in Severe Chronic Obstructive Pulmonary Disease”. Respiratory Medicine. Elsevier BV. doi:10.1053/rmed.2000.0949.
- 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.
- 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.
- 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.
- 2022. "Cognitive and Physical Training in Patients With Chronic Obstructive Pulmonary Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05140226.
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Conditions
Cancer Related
Treatments