Chronic Obstructive Pulmonary DiseaseNCT02860728
Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
A study testing Individualized Resistance Training in people with Chronic Obstructive Pulmonary Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Individualized Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smokers >6 months
- FEV1/FVC <0.7 and lower limit of normal
- 30%< FEV1 pred <70%
- Stable (no exacerbation for >3 months)
Who cannot join
- Cardiovascular and cerebrovascular disease
- Diabetes
- Cardiovascular contraindications to exercise
- Uncontrolled hypertension
- Currently performing regular structured exercise >3x/week for 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Individualized Resistance Training
- Keywords
- COPD, Resistance Training, Exercise Training, Dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Resistance TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training. Receives: Behavioral: Individualized Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT
Measured: Baseline and post 4 weeks (12 sessions) of resistance training
Secondary outcomes (4)
Exercise Tolerance
The change in the time to exhaustion during constant load exercise on a stationary cycle ergometer.
Measured: Baseline and post 4 weeks (12 sessions) of resistance training
Secondary Dyspnea Outcomes
The change in the unpleasantness and sensory qualities of dyspnea measured at an iso-time during the constant load exercise trials post RT
Measured: Baseline and post 4 weeks (12 sessions) of resistance training
Quadriceps Fatigue
Change in the amount of decline in force production after 3 minutes of electrical stimulation of femoral nerve at 25% of maximal voluntary contraction
Measured: Baseline and post 4 weeks (12 sessions) of resistance training
Muscle Strength and Endurance
The change in 6RM quadriceps muscle strength and quadricep muscle endurance at 50% of predicted 1 RM
Measured: Baseline and post 4 weeks (12 sessions) of resistance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Eves, University of British Columbia
- Investigators
- Neil Eves, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860728
- Sponsor's protocol ID
- H16-01019
- Status last verified
- Jun 2022
- First submitted
- 5 Aug 2016
- Last updated
- 13 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Individualized Resistance Training Program to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02860728
- Acronym / sponsor ID
- H16-01019
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Resistance Training, Exercise Training, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Individualized Resistance TrainingPatients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smokers >6 months
- FEV1/FVC <0.7 and lower limit of normal
- 30%< FEV1 pred <70%
- Stable (no exacerbation for >3 months)
Key exclusion criteria (5 listed)
- Cardiovascular and cerebrovascular disease
- Diabetes
- Cardiovascular contraindications to exercise
- Uncontrolled hypertension
- Currently performing regular structured exercise >3x/week for 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Resistance TrainingLower 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. | Behavioural | Resistance training |
Primary outcome
Dyspnea
Time frame: Baseline and post 4 weeks (12 sessions) of resistance training
The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT
4 secondary outcomes
Exercise Tolerance
Time frame: Baseline and post 4 weeks (12 sessions) of resistance training
Secondary Dyspnea Outcomes
Time frame: Baseline and post 4 weeks (12 sessions) of resistance training
Quadriceps Fatigue
Time frame: Baseline and post 4 weeks (12 sessions) of resistance training
Muscle Strength and Endurance
Time frame: Baseline and post 4 weeks (12 sessions) of resistance training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Eves, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Resistance Training in people with Chronic Obstructive Pulmonary Disease, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: Baseline and post 4 weeks (12 sessions) of resistance training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.