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Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Individualized Resistance Training
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Resistance Training, Exercise Training, Dyspnea

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistance training

Arm Description

Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training.

Outcomes

Primary Outcome Measures

Dyspnea
The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT

Secondary Outcome Measures

Exercise Tolerance
The change in the time to exhaustion during constant load exercise on a stationary cycle ergometer.
Secondary Dyspnea Outcomes
The change in the unpleasantness and sensory qualities of dyspnea measured at an iso-time during the constant load exercise trials post RT
Quadriceps Fatigue
Change in the amount of decline in force production after 3 minutes of electrical stimulation of femoral nerve at 25% of maximal voluntary contraction
Muscle Strength and Endurance
The change in 6RM quadriceps muscle strength and quadricep muscle endurance at 50% of predicted 1 RM

Full Information

First Posted
August 5, 2016
Last Updated
June 9, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02860728
Brief Title
Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
Official Title
A Novel Individualized Resistance Training Program to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Resistance Training, Exercise Training, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Patients with COPD will participate in 4 weeks (12 sessions) of individualized, non-linear, lower body resistance training.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Resistance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspnea
Description
The change in the sensory intensity of dyspnea measured at an iso-time during the constant load exercise trials post RT
Time Frame
Baseline and post 4 weeks (12 sessions) of resistance training
Secondary Outcome Measure Information:
Title
Exercise Tolerance
Description
The change in the time to exhaustion during constant load exercise on a stationary cycle ergometer.
Time Frame
Baseline and post 4 weeks (12 sessions) of resistance training
Title
Secondary Dyspnea Outcomes
Description
The change in the unpleasantness and sensory qualities of dyspnea measured at an iso-time during the constant load exercise trials post RT
Time Frame
Baseline and post 4 weeks (12 sessions) of resistance training
Title
Quadriceps Fatigue
Description
Change in the amount of decline in force production after 3 minutes of electrical stimulation of femoral nerve at 25% of maximal voluntary contraction
Time Frame
Baseline and post 4 weeks (12 sessions) of resistance training
Title
Muscle Strength and Endurance
Description
The change in 6RM quadriceps muscle strength and quadricep muscle endurance at 50% of predicted 1 RM
Time Frame
Baseline and post 4 weeks (12 sessions) of resistance training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Eves, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

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Resistance Training to Prehabilitate Patients With Chronic Obstructive Pulmonary Disease

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