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Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03752892
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 26, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
Cycle exercise endurance time [ Time Frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation ]
tolerance (time) of a constant power high intensity cycle endurance test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03752892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
health-related quality of life [ Time Frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation ]
using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE Randomized Controlled Trial of Partitioned Aerobic Exercise Training of Patients With Idiopathic Pulmonary Fibrosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
prospective, randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:
assessor of the primary outcomes will be blind to the participant's group allocation
Primary Purpose: Treatment
Condition  ICMJE Lung; Disease, Interstitial, With Fibrosis
Intervention  ICMJE
  • Other: intervention -1-leg cycle training
    partitioned aerobic exercise training
  • Other: usual care - 2-leg cycle training
    conventional aerobic exercise training
Study Arms  ICMJE
  • Experimental: intervention -1-leg cycle training
    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.
    Intervention: Other: intervention -1-leg cycle training
  • Active Comparator: usual care - 2-leg cycle training
    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: Other: usual care - 2-leg cycle training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tom Dolmage 1-416-243-3600 ext 2185 tom.dolmage@westpark.org
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03752892
Other Study ID Numbers  ICMJE 1L-IPF-RCT-RG2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roger Goldstein, West Park Healthcare Centre
Study Sponsor  ICMJE West Park Healthcare Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roger S Goldstein West Park Healthcare Centre
PRS Account West Park Healthcare Centre
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP