- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860728
Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
June 9, 2022 updated by: Neil Eves, University of British Columbia
A Novel Individualized Resistance Training Program to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased mortality associated with this disease.
Muscle dysfunction also contributes to dyspnea intensity and the ability to sustain exercise, making aerobic exercise training intolerable at the intensity and/or volume required to achieve clinically important changes.
Resistance training (RT) is an attractive exercise modality because it is efficacious and more tolerable initially.
No work has examined whether a short-term RT program can reduce exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Skeletal muscle dysfunction is common in patients with COPD and has been recognized as a contributing factor to reduced exercise capacity, health related quality of life and increased mortality associated with this disease.
Several structural changes in the limb muscles of patients have previously been reported and have been linked to the known reductions in muscle strength and endurance commonly reported in COPD.
Muscle dysfunction, lower extremity muscle strength, and muscle fatigue also contribute to the intensity of dyspnea and the ability to sustain exercise mostly through stimulation of type III and IV muscle afferents.
As such, many patients who primarily perform aerobic exercise training as part of pulmonary rehabilitation are unable to tolerate the intensity and/or volume of exercise required to achieve clinically important changes in exercise capacity or symptom relief.
Resistance training (RT) is an attractive exercise modality for patients with COPD because it is efficacious and often more tolerable initially.
To our knowledge no one has examined whether similar benefits to those elicited by longer RT programs can be attained in just 4 weeks using multi-joint, multi-muscle exercises and individualized progression.
If a short term RT program can improve muscle quality, enhance endurance, and reduce type III and IV afferent activity then it would reduce the drive to breathe and thus dyspnea.
These adaptations would likely translate into improved exercise tolerance making it feasible to "pre-habilitate" COPD patients with tolerable RT, allowing them to achieve a higher volume/intensity of endurance training, thus making pulmonary rehabilitation more effective.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-smokers >6 months
- FEV1/FVC <0.7 and lower limit of normal
- 30%< FEV1 pred <70%
- Stable (no exacerbation for >3 months)
Exclusion Criteria:
- Cardiovascular and cerebrovascular disease
- Diabetes
- Cardiovascular contraindications to exercise
- Uncontrolled hypertension
- Currently performing regular structured exercise >3x/week for 30 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance training
Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training.
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Lower body resistance exercises will be prescribed in various combinations over multiple days and individually modified and progressed to achieve advances in both movement pattern, intensity, and exercise volume.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
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The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT
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Baseline and post 4 weeks (12 sessions) of resistance training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Tolerance
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
|
The change in the time to exhaustion during constant load exercise on a stationary cycle ergometer.
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Baseline and post 4 weeks (12 sessions) of resistance training
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Secondary Dyspnea Outcomes
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
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The change in the unpleasantness and sensory qualities of dyspnea measured at an iso-time during the constant load exercise trials post RT
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Baseline and post 4 weeks (12 sessions) of resistance training
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Quadriceps Fatigue
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
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Change in the amount of decline in force production after 3 minutes of electrical stimulation of femoral nerve at 25% of maximal voluntary contraction
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Baseline and post 4 weeks (12 sessions) of resistance training
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Muscle Strength and Endurance
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
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The change in 6RM quadriceps muscle strength and quadricep muscle endurance at 50% of predicted 1 RM
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Baseline and post 4 weeks (12 sessions) of resistance training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Eves, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
August 5, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 9, 2016
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-01019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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