NCT02283580

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

November 3, 2014

Last Update Submit

March 6, 2018

Conditions

Keywords

COPDHealthy adultsResistance trainingElastic bandsLimb muscle functionVolunteers

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

EXPERIMENTAL

Low load, high-repetitive resistance training. * single limb at a time (e.g., one arm or one leg) * elastic bands

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

Other: Two limb

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.

Single limb resistance training

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.

Two limb resistance training

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, G1S4V3, Canada

Location

Centre de recherche de l'IUCPQ

Québec, G1V 4G5, Canada

Location

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.

  • Nyberg 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

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

Locations