Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

June 9, 2022 updated by: Neil Eves, University of British Columbia

A Novel Individualized Resistance Training Program to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

Structural changes in skeletal muscles of patients with chronic obstructive pulmonary disease (COPD) have been linked to impaired muscle function, reduced exercise capacity, and increased mortality associated with this disease. Muscle dysfunction also contributes to dyspnea intensity and the ability to sustain exercise, making aerobic exercise training intolerable at the intensity and/or volume required to achieve clinically important changes. Resistance training (RT) is an attractive exercise modality because it is efficacious and more tolerable initially. No work has examined whether a short-term RT program can reduce exertional symptoms and improve exercise tolerance (dyspnea and leg fatigue) in patients with COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Skeletal muscle dysfunction is common in patients with COPD and has been recognized as a contributing factor to reduced exercise capacity, health related quality of life and increased mortality associated with this disease. Several structural changes in the limb muscles of patients have previously been reported and have been linked to the known reductions in muscle strength and endurance commonly reported in COPD. Muscle dysfunction, lower extremity muscle strength, and muscle fatigue also contribute to the intensity of dyspnea and the ability to sustain exercise mostly through stimulation of type III and IV muscle afferents. As such, many patients who primarily perform aerobic exercise training as part of pulmonary rehabilitation are unable to tolerate the intensity and/or volume of exercise required to achieve clinically important changes in exercise capacity or symptom relief. Resistance training (RT) is an attractive exercise modality for patients with COPD because it is efficacious and often more tolerable initially. To our knowledge no one has examined whether similar benefits to those elicited by longer RT programs can be attained in just 4 weeks using multi-joint, multi-muscle exercises and individualized progression. If a short term RT program can improve muscle quality, enhance endurance, and reduce type III and IV afferent activity then it would reduce the drive to breathe and thus dyspnea. These adaptations would likely translate into improved exercise tolerance making it feasible to "pre-habilitate" COPD patients with tolerable RT, allowing them to achieve a higher volume/intensity of endurance training, thus making pulmonary rehabilitation more effective.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • University of British Columbia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smokers >6 months
  • FEV1/FVC <0.7 and lower limit of normal
  • 30%< FEV1 pred <70%
  • Stable (no exacerbation for >3 months)

Exclusion Criteria:

  • Cardiovascular and cerebrovascular disease
  • Diabetes
  • Cardiovascular contraindications to exercise
  • Uncontrolled hypertension
  • Currently performing regular structured exercise >3x/week for 30 minutes

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance training
Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training.
Behavioral: Individualized Resistance Training
Lower body resistance exercises will be prescribed in various combinations over multiple days and individually modified and progressed to achieve advances in both movement pattern, intensity, and exercise volume.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT
Baseline and post 4 weeks (12 sessions) of resistance training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise Tolerance
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
The change in the time to exhaustion during constant load exercise on a stationary cycle ergometer.
Baseline and post 4 weeks (12 sessions) of resistance training
Secondary Dyspnea Outcomes
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
The change in the unpleasantness and sensory qualities of dyspnea measured at an iso-time during the constant load exercise trials post RT
Baseline and post 4 weeks (12 sessions) of resistance training
Quadriceps Fatigue
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
Change in the amount of decline in force production after 3 minutes of electrical stimulation of femoral nerve at 25% of maximal voluntary contraction
Baseline and post 4 weeks (12 sessions) of resistance training
Muscle Strength and Endurance
Time Frame: Baseline and post 4 weeks (12 sessions) of resistance training
The change in 6RM quadriceps muscle strength and quadricep muscle endurance at 50% of predicted 1 RM
Baseline and post 4 weeks (12 sessions) of resistance training

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neil Eves, PhD, University of British Columbia

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H16-01019

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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