Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis

NCT03752892 | Active Not Recruiting

• 1 other identifier: 1L-IPF-RCT-RG2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Disease, Interstitial, With Fibrosis

Keywords

pulmonary rehabilitation; exercise training

Outcome Measures

Primary Outcomes (1)

• Cycle exercise endurance time

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

  Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation

Secondary Outcomes (1)

• health-related quality of life

  Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation

Study Arms (2)

intervention -1-leg cycle training

EXPERIMENTAL

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.

Other: intervention -1-leg cycle training

usual care - 2-leg cycle training

ACTIVE COMPARATOR

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.

Other: usual care - 2-leg cycle training

Interventions

intervention -1-leg cycle training OTHER

partitioned aerobic exercise training

intervention -1-leg cycle training

usual care - 2-leg cycle training OTHER

conventional aerobic exercise training

usual care - 2-leg cycle training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger S Goldstein

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessor of the primary outcomes will be blind to the participant's group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Respiratory Rehabilitation

Model Details: prospective, randomized controlled trial

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: March 1, 2019
• Primary Completion: April 28, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)