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Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

Primary Purpose

Lung; Disease, Interstitial, With Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intervention -1-leg cycle training
usual care - 2-leg cycle training
Sponsored by
West Park Healthcare Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung; Disease, Interstitial, With Fibrosis focused on measuring pulmonary rehabilitation, exercise training

Eligibility Criteria

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

Inclusion Criteria:

  • confirmed idiopathic pulmonary fibrosis
  • Clinically stable
  • enrolled in pulmonary rehabilitation

Exclusion Criteria:

  • co-morbidities that might impair their ability to safely complete a pulmonary rehabilitation program
  • complete a pulmonary rehabilitation program within the previous 6 months
  • experienced an exacerbation less than six weeks before participation

Sites / Locations

  • West Park Healthcare CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention -1-leg cycle training

usual care - 2-leg cycle training

Arm Description

Primary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity.

Primary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity.

Outcomes

Primary Outcome Measures

Cycle exercise endurance time
tolerance (time) of a constant power high intensity cycle endurance test

Secondary Outcome Measures

health-related quality of life
using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]

Full Information

First Posted
November 20, 2018
Last Updated
May 5, 2023
Sponsor
West Park Healthcare Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03752892
Brief Title
Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis
Official Title
Randomized Controlled Trial of Partitioned Aerobic Exercise Training of Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe enough for a good workout. One way to improve the exercise training is to reduce the number of muscles being trained together. By training one leg at a time, the patient does not have to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in patients with IPF. This study will help decide whether one-legged exercise training is better at improving a patient's exercise endurance compared to the usual way of exercising with both legs at the same time.
Detailed Description
Dyspnea is a major clinical manifestation of idiopathic pulmonary fibrosis (IPF). It becomes more severe and more limiting as the condition progresses. Many professional respiratory societies recommend that the standard of care for IPF includes pulmonary rehabilitation (PR). However, some patients with IPF are so limited by dyspnea that they are unable to tolerate levels of aerobic exercise training sufficient to induce the physiological adaptations that will improve functional and health related outcomes. Therefore, there is a need for exercise training interventions that will enhance the muscle training stimulus above that currently possible in individuals with a marked ventilatory limitation. Partitioning large muscle exercise using one-legged high intensity training is more effective than conventional aerobic training when applied to patients with central ventilatory or cardiac limitation. Effective partitioned exercise enables an increased muscle load with less ventilatory load. It increases the training stimulus to the muscles as they work at a high intensity, relative to their current aerobic state, necessary to increase their capacity. As long as the active muscle mass can create the same demands on the central exercise components of the heart and circulation as does conventional two-legged exercise, this simple, inexpensive novel approach, will stimulate leg muscles sufficiently to improve overall cardiorespiratory fitness. For example, in those with chronic obstructive pulmonary disease, one-legged training has been shown to provide a muscle specific stimulus sufficient to improve whole body peak oxygen uptake during pulmonary rehabilitation. A preliminary acute study of patients with IPF has demonstrated that during a laboratory simulation of an exercise training session, partitioning aerobic exercise extended exercise tolerance. Participants achieved double the work whilst exercising with one leg compared with two-legged cycle exercise. Partitioned training may therefore be an effective approach to exercise training in patients with IPF enrolled in PR. The advent of pharmacological agents that stabilize the clinical course of IPF presents a window of opportunity for exercise rehabilitation to further improve function. The aim of this proposed study is to determine whether, within the setting of PR, partitioned aerobic exercise training with a one-legged cycle training regime is more effective than the conventional two-legged regimen in increasing exercise tolerance. The study hypothesis is that partitioned aerobic exercise training, using a one-legged training regime is more effective than conventional two-legged exercise training in increasing exercise tolerance (measured by constant power endurance) and cardiorespiratory fitness as measured by maximal oxygen uptake. The results will inform the best approach to produce clinically meaningful improvements in dyspnea and health status for those with IPF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung; Disease, Interstitial, With Fibrosis
Keywords
pulmonary rehabilitation, exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized controlled trial
Masking
Outcomes Assessor
Masking Description
assessor of the primary outcomes will be blind to the participant's group allocation
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention -1-leg cycle training
Arm Type
Experimental
Arm Description
Primary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity.
Arm Title
usual care - 2-leg cycle training
Arm Type
Active Comparator
Arm Description
Primary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity.
Intervention Type
Other
Intervention Name(s)
intervention -1-leg cycle training
Intervention Description
partitioned aerobic exercise training
Intervention Type
Other
Intervention Name(s)
usual care - 2-leg cycle training
Intervention Description
conventional aerobic exercise training
Primary Outcome Measure Information:
Title
Cycle exercise endurance time
Description
tolerance (time) of a constant power high intensity cycle endurance test
Time Frame
Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
Secondary Outcome Measure Information:
Title
health-related quality of life
Description
using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]
Time Frame
Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: confirmed idiopathic pulmonary fibrosis Clinically stable enrolled in pulmonary rehabilitation Exclusion Criteria: co-morbidities that might impair their ability to safely complete a pulmonary rehabilitation program complete a pulmonary rehabilitation program within the previous 6 months experienced an exacerbation less than six weeks before participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Dolmage
Phone
1-416-243-3600
Ext
2185
Email
tom.dolmage@westpark.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Dolmage
Phone
4162433600
Email
tom.dolmage@westpark.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

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