Pulmonary Disease, Chronic ObstructiveNCT02283580
Low Load, High-repetitive Elastic Band Resistance Training in COPD
A study testing Single limb and Two limb in people with Pulmonary Disease, Chronic Obstructive and Healthy, run by Laval University at 2 sites in Canada.
Trial summary
Recent work have shown that low load, high-repetitive single limb resistance training, if compared to a control, can increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of limiting exertional symptoms. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Healthy
- What is being tested?
- Single limb and Two limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2014to Feb 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: > 40
- Cumulative (current or ex) smoking history >10 pack-years
- COPD with non-reversible airflow obstruction corresponding to GOLD 3 and 4
- Age: > 40
- Normal pulmonary function tests.
Who cannot join
- Recent exacerbation (< 6 weeks)
- Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program
- Recent cancer
- Unstable cardiac disease and cardiac stimulator
- Asthma
- Low body weight or obesity (Body Mass Index < 20 Kg/m2 and or > 30kg/m2)
Show all 10Show fewer
- Significant hypoxemia at rest (SaO2 <85%)
- a daily dose > 10mg of systemic prednisone.
- Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program
- Physically active (>9) according the Voorips questionnaire.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1S4V3
Centre de recherche de l'IUCPQ
Québec, G1V 4G5
About this study
Official title: Intramuscular and Functional Effects and Mechanism of Partitioning the Exercising Muscle Mass in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Recent work have shown that low load, high-repetitive single limb resistance training, if compared to a control, can increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of limiting exertional symptoms. However, no comparison to another exercise regimen have been performed. In addition neither the intramuscular nor the mechanism of this exercise regimen have been investigated and represents the aim of the proposed project. We will in a prospective, assessor-blind; block randomized controlled, parallel-group trial compare single-limb to two-limb low load, high-repetitive resistance training in patients with severe and very severe COPD
The research hypothesizes are:
Read more
- that single-limb low-load high-repetitive resistance training will provide larger gain in the 6-min walking distance than two-limb low-load high- repetitive resistance training in patients with severe to very severe (stage III-IV) COPD.
- that eight weeks of single limb training should also be associated with larger physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and structural (muscle protein synthesis, fiber-type distribution and capillarization) muscle adaptations to training, lower cardio- respiratory demand, as well a greater increase in health-related quality of life in comparison to two-limbs simultaneous training.
We will also compare the groups at baseline to investigate the acute effects and mechanisms of single-limb to two-limb low load, high-repetitive resistance training, a comparison that also will include healthy matched controls.
The research hypothesizes are:
- that involving a large muscle mass during exercise (e.g., two-limb low load, high-repetition resistance training) compared to involving a small muscle mass during training (e.g., single limb low load, high-repetition resistance training) would lead to larger restraints on the cardiorespiratory system in patients with severe to very severe COPD. Conversely, single limb interventions should produce less dyspnea and more muscle deoxygenation and fatigue than two-limb simultaneous exercise while healthy controls will be able to perform both legs/arms exercise without a central constraint, and no negative consequences on muscle fatigue or exercise stimulus.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Healthy
- Being tested
- Single limb, Two limb
- Keywords
- COPD, Healthy adults, Resistance training, Elastic bands, Limb muscle function, Volunteers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single limbOther
Low load, high-repetitive resistance training.
- single limb at a time (e.g., one arm or one leg)
- elastic bands
- 8 weeks
- 3 times/week,
- each session 60 minutes
- seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension
- maximal number of repetitions (RM) * 3 sets in each exercise.
Two limbOther
Low load, high-repetitive resistance training.
- two limbs at a time (e.g., both arms or both legs)
- elastic bands
- 8 weeks
- 3 times/week,
- each session 60 minutes
- seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension
- maximal number of repetitions (RM) * 3 sets in each exercise.
| Study group | Role | What they receive |
|---|---|---|
| Single limb resistance training | Experimental | Low load, high-repetitive resistance training.
* single limb at a time (e.g., one arm or one leg)
* elastic bands Receives: Other: Single limb |
| Two limb resistance training | Active comparator | Low load, high-repetitive resistance training.
* two limbs at a time (e.g., both arms or both legs)
* elastic bands Receives: Other: Two limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking capacity (distance [meters])
Meters walked on the 6- minute walk test. The walking course will be 30 meters in length and the patients will be instructed in accordance to standardized guidelines to walk as far as possible in 6 minutes. One practice test will be performed to minimize risk of learning effect. The highest walking distance of the two 6-min walks will be chosen as baseline value.
Measured: Baseline (week 0), 8 weeks
Secondary outcomes (8)
Unsupported upper extremity endurance capacity (time [seconds])
Endurance time (seconds) on the Unsupported Upper Limb Exercise test (UULEX) will be used to measure unsupported endurance capacity in the upper extremity. Participants will hold a plastic bar (0.2 kg), at shoulder width and will be asked to raise it from hip to the UULEX eight level chart for one minute at each level with a cadence of 30 movements per minute. If a patient reaches the highest level, the plastic bar will be replaced by a heavier one every minute. There are five different weights of the bar (0.2, 0.5, 1, 1.5, 2 Kg) and the patient will continue on the highest level until symptom limitation.
Measured: Baseline (week 0), 8 weeks
Isokinetic limb muscle function (Endurance [total work], strength [peak torque])
Isokinetic limb muscle function during one-arm shoulder flexion, one-leg knee extension and two-leg knee extension will be assessed. The subjects are informed to flex their arm or extend their leg(s) 25 consecutive times using maximal effort at each repetition during the concentric phase and to rest during the eccentric phase of the movement. Two different aspects of isokinetic muscle function will be measured. Peak torque from the highest contraction will be used for maximal strength and the total work generated from all contractions will be used for limb muscle endurance. The tests will be performed at an angular velocity of 60°• s-1,
Measured: Baseline (week 0), 8 weeks
Ventilatory response
Respiratory response during all elastic band exercises (1: one-arm shoulder flexion, biceps flexion, chest press and latissimus row 2: two-arm shoulder flexion, biceps flexion, chest press and latissimus row 3: one-leg knee extension, plantar flexion and leg curl 4: two-leg knee extension, plantar flexion and leg curl) will be determined using a portable gas analysis system (Oxycon Mobile, Viasys Healthcare, Jaeger, Germany. Minute ventilation (VE) oxygen uptake (VO2), carbon dioxide excretion (VCO2,), heart rate (HR), respiratory exchange ratio (RER) and pulsed oxygen saturation (SpO2) will be collected
Measured: Baseline (week 0), 8 weeks
Cardiac output
Arterial blood pressures and cardiac output will be non-invasively measured by a finger photoplethysmography device (BMEYE, Nexfin HD, Academic Medical Center, Amsterdam, The Netherlands) during all elastic band exercises detailed above.
Measured: Week 0 and week 8
Muscle deoxygenation
Changes of deoxyhemoglobin/myoglobin concentrations will be non-invasively measured by near-infrared spectroscopy of vastus lateralis muscle. Obtained during all elastic band exercises detailed above
Measured: Baseline (week 0), week 8
Dyspnea (Rating [0-10])
Magnitude of dyspnea after each exercise and test will be measured by the Borg CR 10 scale
Measured: Baseline (week 0), 8 weeks
Limb muscle fatigue (Rating [0-10])
Magnitude of limb muscle fatigue after each exercise and test will be measured by the Borg CR 10 scale
Measured: Baseline (week 0), 8 weeks
Isometric muscle strength (maximum voluntary isometric contraction [MVIC], and supramaximal twitch tension (TW) and muscle fatigue
Directly before and after all elastic band exercises (1: one-arm shoulder flexion, 2: two-arm shoulder flexion, 3: one-leg knee extension, 4: two-leg knee extension) generated force of both MVIC and TW will be measured by an isometric force gauge while participants will be in a standardized positioning. The occurrence of quadriceps (knee extension) or deltoid (shoulder flexion) fatigue induced by the exercise regimens will be quantified by measuring the fall in both MVIC and TW 15 after the elastic band resistance exercises.
Measured: Baseline (week 0), 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Saey, Didier, M.D., Maltais, Francois, M.D.
- Responsible party
- Principal investigator, Andre Nyberg, Laval University
- Investigators
- Francois Maltais, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)Didier Saey, Pht, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283580
- Sponsor's protocol ID
- LLHR-COPD-2014
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nyberg A, Martin M, Saey D, Milad N, Patoine D, Morissette MC, Auger D, Stal P, Maltais F. Effects of Low-Load/High-Repetition Resistance Training on Exercise Capacity, Health Status, and Limb Muscle Adaptation in Patients With Severe COPD: A Randomized Controlled Trial. Chest. 2021 May;159(5):1821-1832. doi: 10.1016/j.chest.2020.12.005. Epub 2020 Dec 13.
PubMed 33316237Nyberg A, Saey D, Martin M, Maltais F. Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:194. doi: 10.1186/s13063-015-0698-x.
PubMed 25927288
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular and Functional Effects and Mechanism of Partitioning the Exercising Muscle Mass in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02283580
- Acronym / sponsor ID
- LLHR-COPD-2014
- Conditions
- Pulmonary Disease, Chronic Obstructive, Healthy
- Keywords
- COPD, Healthy adults, Resistance training, Elastic bands, Limb muscle function, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Saey, Didier, M.D., Maltais, Francois, M.D.
- Study start
- Nov 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Nov 2014 (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.
Recent work have shown that low load, high-repetitive single limb resistance training, if compared to a control, can increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while avoiding the occurrence of limiting exertional symptoms. However, no comparison to another exercise regimen have been performed. In addition neither the intramuscular nor the mechanism of this exercise regimen have been investigated and represents the aim of the proposed project. We will in a prospective, assessor-blind; block randomized controlled, parallel-group trial compare single-limb to two-limb low load, high-repetitive resistance training in patients with severe and very severe COPD
The research hypothesizes are:
- that single-limb low-load high-repetitive resistance training will provide larger gain in the 6-min walking distance than two-limb low-load high- repetitive resistance training in patients with severe to very severe (stage III-IV) COPD.
- that eight weeks of single limb training should also be associated with larger physiological (increased muscle endurance, less muscle fatigue and deoxygenation) and structural (muscle protein synthesis, fiber-type distribution and capillarization) muscle adaptations to training, lower cardio- respiratory demand, as well a greater increase in health-related quality of life in comparison to two-limbs simultaneous training.
We will also compare the groups at baseline to investigate the acute effects and mechanisms of single-limb to two-limb low load, high-repetitive resistance training, a comparison that also will include healthy matched controls.
The research hypothesizes are:
- that involving a large muscle mass during exercise (e.g., two-limb low load, high-repetition resistance training) compared to involving a small muscle mass during training (e.g., single limb low load, high-repetition resistance training) would lead to larger restraints on the cardiorespiratory system in patients with severe to very severe COPD. Conversely, single limb interventions should produce less dyspnea and more muscle deoxygenation and fatigue than two-limb simultaneous exercise while healthy controls will be able to perform both legs/arms exercise without a central constraint, and no negative consequences on muscle fatigue or exercise stimulus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single limb resistance training | Experimental | Other: Single limbLow load, high-repetitive resistance training. * single limb at a time (e.g., one arm or one leg) * elastic bands |
| Two limb resistance training | Active comparator | Other: Two limbLow load, high-repetitive resistance training. * two limbs at a time (e.g., both arms or both legs) * elastic bands |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: > 40
- Cumulative (current or ex) smoking history >10 pack-years
- COPD with non-reversible airflow obstruction corresponding to GOLD 3 and 4
- Age: > 40
- Normal pulmonary function tests.
Key exclusion criteria (10 listed)
- Recent exacerbation (< 6 weeks)
- Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program
- Recent cancer
- Unstable cardiac disease and cardiac stimulator
- Asthma
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 |
|---|---|---|
| Single limbLow load, high-repetitive resistance training. * single limb at a time (e.g., one arm or one leg) * elastic bands * 8 weeks * 3 times/week, * each session 60 minutes * seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension * maximal number of repetitions (RM) * 3 sets in each exercise. | Other | Single limb resistance training |
| Two limbLow load, high-repetitive resistance training. * two limbs at a time (e.g., both arms or both legs) * elastic bands * 8 weeks * 3 times/week, * each session 60 minutes * seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension * maximal number of repetitions (RM) * 3 sets in each exercise. | Other | Two limb resistance training |
Primary outcome
Walking capacity (distance [meters])
Time frame: Baseline (week 0), 8 weeks
Meters walked on the 6- minute walk test. The walking course will be 30 meters in length and the patients will be instructed in accordance to standardized guidelines to walk as far as possible in 6 minutes. One practice test will be performed to minimize risk of learning effect. The highest walking distance of the two 6-min walks will be chosen as baseline value.
8 secondary outcomes
Unsupported upper extremity endurance capacity (time [seconds])
Time frame: Baseline (week 0), 8 weeks
Isokinetic limb muscle function (Endurance [total work], strength [peak torque])
Time frame: Baseline (week 0), 8 weeks
Ventilatory response
Time frame: Baseline (week 0), 8 weeks
Cardiac output
Time frame: Week 0 and week 8
Muscle deoxygenation
Time frame: Baseline (week 0), week 8
Dyspnea (Rating [0-10])
Time frame: Baseline (week 0), 8 weeks
Limb muscle fatigue (Rating [0-10])
Time frame: Baseline (week 0), 8 weeks
Isometric muscle strength (maximum voluntary isometric contraction [MVIC], and supramaximal twitch tension (TW) and muscle fatigue
Time frame: Baseline (week 0), 8 weeks
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 7 Mar 2018.
- Derived from this study: PubMed 33316237Nyberg A, Martin M, Saey D, Milad N, Patoine D, Morissette MC, Auger D, Stal P, Maltais F. Effects of Low-Load/High-Repetition Resistance Training on Exercise Capacity, Health Status, and Limb Muscle Adaptation in Patients With Severe COPD: A Randomized Controlled Trial. Chest. 2021 May;159(5):1821-1832. doi: 10.1016/j.chest.2020.12.005. Epub 2020 Dec 13.
- Derived from this study: PubMed 25927288Nyberg A, Saey D, Martin M, Maltais F. Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:194. doi: 10.1186/s13063-015-0698-x.
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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.
Francois Maltais, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Didier Saey, Pht, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single limb and Two limb in people with Pulmonary Disease, Chronic Obstructive and Healthy, run by Laval University at 2 sites 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 5 inclusion and 10 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Walking capacity (distance [meters]) (time frame: Baseline (week 0), 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02283580, which also lists 2 linked publications.
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 7 Mar 2018.