Low Load, High-repetitive Elastic Band Resistance Training in COPD
Intramuscular and Functional Effects and Mechanism of Partitioning the Exercising Muscle Mass in Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
50
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 3, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 7, 2018
March 1, 2018
2.3 years
November 3, 2014
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (week 0), 8 weeks
Secondary Outcomes (8)
Unsupported upper extremity endurance capacity (time [seconds])
Baseline (week 0), 8 weeks
Isokinetic limb muscle function (Endurance [total work], strength [peak torque])
Baseline (week 0), 8 weeks
Ventilatory response
Baseline (week 0), 8 weeks
Cardiac output
Week 0 and week 8
Muscle deoxygenation
Baseline (week 0), week 8
- +3 more secondary outcomes
Study Arms (2)
Single limb resistance training
EXPERIMENTALLow load, high-repetitive resistance training. * single limb at a time (e.g., one arm or one leg) * elastic bands
Two limb resistance training
ACTIVE COMPARATORLow load, high-repetitive resistance training. * two limbs at a time (e.g., both arms or both legs) * elastic bands
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age: \> 40
- Cumulative (current or ex) smoking history \>10 pack-years
- COPD with non-reversible airflow obstruction corresponding to GOLD 3 and 4
You may not qualify if:
- 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)
- Significant hypoxemia at rest (SaO2 \<85%)
- a daily dose \> 10mg of systemic prednisone.
- Age: \> 40
- Normal pulmonary function tests.
- Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program
- Physically active (\>9) according the Voorips questionnaire.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Saey, Didier, M.D.collaborator
- Maltais, Francois, M.D.collaborator
Study Sites (2)
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1S4V3, Canada
Centre de recherche de l'IUCPQ
Québec, G1V 4G5, Canada
Related Publications (2)
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.
PMID: 33316237DERIVEDNyberg 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.
PMID: 25927288DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois Maltais, MD
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
- PRINCIPAL INVESTIGATOR
Didier Saey, Pht, PhD
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 3, 2014
First Posted
November 5, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 7, 2018
Record last verified: 2018-03