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

March 6, 2018 updated by: Andre Nyberg, Laval University

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:

  • 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 Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 4G5
        • Centre de recherche de l'IUCPQ
    • Quebec
      • Quebec city, Quebec, Canada, G1S4V3
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single limb resistance training

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.

  • 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.
Active Comparator: Two limb resistance training

Low load, high-repetitive resistance training.

  • two limbs at a time (e.g., both arms or both legs)
  • elastic bands

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unsupported upper extremity endurance capacity (time [seconds])
Time Frame: Baseline (week 0), 8 weeks
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.
Baseline (week 0), 8 weeks
Isokinetic limb muscle function (Endurance [total work], strength [peak torque])
Time Frame: Baseline (week 0), 8 weeks
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,
Baseline (week 0), 8 weeks
Ventilatory response
Time Frame: Baseline (week 0), 8 weeks
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
Baseline (week 0), 8 weeks
Cardiac output
Time Frame: Week 0 and week 8
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.
Week 0 and week 8
Muscle deoxygenation
Time Frame: Baseline (week 0), week 8
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
Baseline (week 0), week 8
Dyspnea (Rating [0-10])
Time Frame: Baseline (week 0), 8 weeks
Magnitude of dyspnea after each exercise and test will be measured by the Borg CR 10 scale
Baseline (week 0), 8 weeks
Limb muscle fatigue (Rating [0-10])
Time Frame: Baseline (week 0), 8 weeks
Magnitude of limb muscle fatigue after each exercise and test will be measured by the Borg CR 10 scale
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
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.
Baseline (week 0), 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francois Maltais, MD, Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Principal Investigator: Didier Saey, Pht, PhD, Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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