Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03752892
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

West Park Healthcare Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roger S Goldstein
Principal Investigator Affiliation West Park Healthcare Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung; Disease, Interstitial, With Fibrosis
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Other: - intervention -1-leg cycle training

partitioned aerobic exercise training

Other: - usual care - 2-leg cycle training

conventional aerobic exercise training

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

West Park Healthcare Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5

Site Contact

Tom Dolmage

tom.dolmage@westpark.org

4162433600

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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