One-Legged vs Two-Legged Cycle Training for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen by Roger Goldstein, MD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: West Park Healthcare Centre

Disqualifiers: Comorbidities, Recent exacerbation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of one-legged cycle training as a treatment for idiopathic pulmonary fibrosis?

Research on patients with chronic obstructive pulmonary disease (COPD) shows that one-legged cycle training can lead to greater improvements in peak oxygen uptake and work capacity compared to two-legged cycling. This suggests that similar benefits might be seen in patients with idiopathic pulmonary fibrosis, as exercise training has been shown to improve quality of life and physical capacity in both conditions. ^{1 2 3 4 5}

Is one-legged or two-legged cycle training safe for humans?

Exercise training, including one-legged and two-legged cycling, appears to be safe for people with chronic obstructive pulmonary disease (COPD), with a favorable balance of benefits over risks. Although specific safety data for idiopathic pulmonary fibrosis (IPF) is not detailed, exercise training is generally recommended for improving quality of life and physical capacity in both COPD and IPF. ^{1 2 4 5 6}

How does one-legged cycle training differ from other treatments for idiopathic pulmonary fibrosis?

One-legged cycle training is unique because it targets one leg at a time, allowing for higher intensity workouts with less overall strain on the body, which can improve oxygen uptake and physical capacity more effectively than traditional two-legged cycling. ^{1 2 4 5 7}

Research Team

Roger Goldstein, MD, FRCPC

Principal Investigator

West Park Healthcare Centre

Eligibility Criteria

This trial is for stable patients with confirmed idiopathic pulmonary fibrosis who are enrolled in a pulmonary rehab program. It's not suitable for those who've had a recent exacerbation, finished rehab within the last 6 months, or have other health issues that could make rehab unsafe.

Inclusion Criteria

My health condition is currently stable.

I have been diagnosed with idiopathic pulmonary fibrosis.

You are currently participating in a program to help improve your lung function.

Exclusion Criteria

You had a worsening of your condition within six weeks before joining the study.

I have health issues that may make it unsafe for me to do lung rehab exercises.

I finished a lung rehab program in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo partitioned aerobic exercise training with either one-legged or two-legged cycle training for 8 weeks

8 weeks

Weekly visits for exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 1-leg cycle training (Behavioural Intervention)
• 2-leg cycle training (Behavioural Intervention)

Trial Overview The study tests if exercising one leg at a time can improve endurance more than the usual two-leg cycling for people with IPF. The idea is to reduce breathing demand during exercise by working fewer muscles simultaneously.

Participant Groups

Group I: intervention -1-leg cycle training Experimental Treatment 1 Intervention

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.

Group II: usual care - 2-leg cycle training Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

West Park Healthcare Centre Toronto, Canada

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Patients Recruited

2,400+

Findings from Research

In a study involving 22 COPD patients who underwent 6-8 weeks of one-legged cycling as their main aerobic exercise, there was a significant increase in peak oxygen uptake by 8% and a notable improvement in the 6-minute walk test distance by 72 meters, indicating enhanced cardiorespiratory fitness.

The implementation of one-legged cycling was deemed safe by physiotherapists, with 75% of participants expressing a willingness to recommend it to others, suggesting it could be a valuable addition to pulmonary rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. Evans, RA., Dolmage, TE., Mangovski-Alzamora, S., et al.[2015]

In a study of 18 stable COPD patients, one-legged exercise training significantly improved aerobic capacity (peak oxygen uptake) more than traditional two-legged training, with a change of 0.189 L/min compared to 0.006 L/min for the two-legged group.

One-legged training also resulted in greater peak ventilation and lower submaximal heart rate and ventilation, indicating that it effectively reduces metabolic demand while enhancing exercise capacity for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of one-legged exercise training of patients with COPD. Dolmage, TE., Goldstein, RS.[2008]

A multicenter trial involving stage II-IV COPD patients will assess the effects of high-repetitive single limb exercise (HRSLE) combined with patient education over 8 weeks, focusing on improvements in muscle endurance and quality of life.

The study aims to determine not only the primary outcomes of exercise capacity and quality of life but also secondary effects on strength, dyspnea, and mental health, providing a comprehensive understanding of HRSLE's benefits for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the effect of high-repetitive single limb exercises (HRSLE) on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD): study protocol for randomized controlled trial. Nyberg, A., Lindström, B., Wadell, K.[2022]

In a study involving 19 COPD patients, one-leg training (OLT) resulted in a significantly greater increase in whole body peak oxygen uptake (VO2peak) compared to two-leg training (TLT), with VO2peak increasing by 12% in OLT versus 6% in TLT.

The findings suggest that one-leg cycling is more effective for improving aerobic capacity in COPD patients, indicating that muscle limitations rather than cardiovascular issues may be the primary factor affecting VO2peak in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic high intensity one and two legs interval cycling in chronic obstructive pulmonary disease: the sum of the parts is greater than the whole. Bjørgen, S., Hoff, J., Husby, VS., et al.[2021]

Exercise training significantly improves quality of life, physical capacity, and reduces dyspnea in individuals with stable chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

Starting physical activity immediately after a COPD exacerbation can enhance recovery, improve quality of life, and decrease hospital re-admissions, highlighting the importance of tailored exercise programs for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise training can improve dyspnea among persons with COPD and IPF]. Emtner, M., Nykvist, M., Sköld, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

One-Legged Cycle Training for Chronic Obstructive Pulmonary Disease. A Pragmatic Study of Implementation to Pulmonary Rehabilitation. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of one-legged exercise training of patients with COPD. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Assessing the effect of high-repetitive single limb exercises (HRSLE) on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD): study protocol for randomized controlled trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Aerobic high intensity one and two legs interval cycling in chronic obstructive pulmonary disease: the sum of the parts is greater than the whole. [2021]

5. Sweden pubmed.ncbi.nlm.nih.gov

[Exercise training can improve dyspnea among persons with COPD and IPF]. [2022]

6. France pubmed.ncbi.nlm.nih.gov

COPD: benefits of exercise training. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

Aerobic high intensity one-legged interval cycling improves peak oxygen uptake in chronic obstructive pulmonary disease patients; no additional effect from hyperoxia. [2009]