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Low Load, High-repetitive Elastic Band Resistance Training in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Healthy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Single limb
Two limb
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Healthy adults, Resistance training, Elastic bands, Limb muscle function, Volunteers

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria (COPD):

  • Age: > 40
  • Cumulative (current or ex) smoking history >10 pack-years
  • COPD with non-reversible airflow obstruction corresponding to GOLD 3 and 4

Exclusion Criteria:

  • 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.

Inclusion criteria (Healthy controls)

  • Age: > 40
  • Normal pulmonary function tests.

Exclusion criteria

  • Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program
  • Physically active (>9) according the Voorips questionnaire.

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
  • Centre de recherche de l'IUCPQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single limb resistance training

Two limb resistance training

Arm Description

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

Low load, high-repetitive resistance training. two limbs at a time (e.g., both arms or both legs) elastic bands

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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,
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
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.
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
Dyspnea (Rating [0-10])
Magnitude of dyspnea after each exercise and test will be measured by the Borg CR 10 scale
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
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.

Full Information

First Posted
November 3, 2014
Last Updated
March 6, 2018
Sponsor
Laval University
Collaborators
Saey, Didier, M.D., Maltais, Francois, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02283580
Brief Title
Low Load, High-repetitive Elastic Band Resistance Training in COPD
Official Title
Intramuscular and Functional Effects and Mechanism of Partitioning the Exercising Muscle Mass in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Saey, Didier, M.D., Maltais, Francois, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Healthy
Keywords
COPD, Healthy adults, Resistance training, Elastic bands, Limb muscle function, Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single limb resistance training
Arm Type
Experimental
Arm Description
Low load, high-repetitive resistance training. single limb at a time (e.g., one arm or one leg) elastic bands
Arm Title
Two limb resistance training
Arm Type
Active Comparator
Arm Description
Low load, high-repetitive resistance training. two limbs at a time (e.g., both arms or both legs) elastic bands
Intervention Type
Other
Intervention Name(s)
Single limb
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Two limb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking capacity (distance [meters])
Description
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.
Time Frame
Baseline (week 0), 8 weeks
Secondary Outcome Measure Information:
Title
Unsupported upper extremity endurance capacity (time [seconds])
Description
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.
Time Frame
Baseline (week 0), 8 weeks
Title
Isokinetic limb muscle function (Endurance [total work], strength [peak torque])
Description
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,
Time Frame
Baseline (week 0), 8 weeks
Title
Ventilatory response
Description
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
Time Frame
Baseline (week 0), 8 weeks
Title
Cardiac output
Description
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.
Time Frame
Week 0 and week 8
Title
Muscle deoxygenation
Description
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
Time Frame
Baseline (week 0), week 8
Title
Dyspnea (Rating [0-10])
Description
Magnitude of dyspnea after each exercise and test will be measured by the Borg CR 10 scale
Time Frame
Baseline (week 0), 8 weeks
Title
Limb muscle fatigue (Rating [0-10])
Description
Magnitude of limb muscle fatigue after each exercise and test will be measured by the Borg CR 10 scale
Time Frame
Baseline (week 0), 8 weeks
Title
Isometric muscle strength (maximum voluntary isometric contraction [MVIC], and supramaximal twitch tension (TW) and muscle fatigue
Description
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.
Time Frame
Baseline (week 0), 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria (COPD): Age: > 40 Cumulative (current or ex) smoking history >10 pack-years COPD with non-reversible airflow obstruction corresponding to GOLD 3 and 4 Exclusion Criteria: 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. Inclusion criteria (Healthy controls) Age: > 40 Normal pulmonary function tests. Exclusion criteria Neuromuscular and/or orthopedic disorders that compromises participation to an exercise program Physically active (>9) according the Voorips questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Maltais, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Saey, Pht, PhD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1S4V3
Country
Canada
Facility Name
Centre de recherche de l'IUCPQ
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33316237
Citation
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.
Results Reference
derived
PubMed Identifier
25927288
Citation
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.
Results Reference
derived

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Low Load, High-repetitive Elastic Band Resistance Training in COPD

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