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

Overseen By Tom Dolmage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Disqualifiers: Comorbidities, Recent exacerbation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercising one leg at a time can improve exercise endurance in people with idiopathic pulmonary fibrosis (IPF) more effectively than using both legs simultaneously. IPF is a lung disease that makes deep breathing difficult, limiting workouts. Participants will either engage in one-legged cycle training (also known as 1-leg cycle training) or follow the usual two-legged cycling routine to identify the more effective method. Ideal candidates for this trial have confirmed IPF, are stable in their condition, and are already participating in a pulmonary rehabilitation program. As an unphased trial, this study allows participants to contribute to innovative research that could enhance exercise strategies for IPF patients.

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 prior data suggests that this training method is safe for patients with idiopathic pulmonary fibrosis?

Previous studies have shown that participants tolerate one-legged cycling well. Research indicates that this method can ease breathing during exercise, which benefits people with idiopathic pulmonary fibrosis (IPF). This approach means that even during exercise, the lungs exert less effort than when using both legs. Participants who engaged in one-legged cycling doubled their exercise output compared to using both legs, without serious side effects.

Training focuses on one leg at a time, distributing the effort and aiding those with breathing difficulties. Earlier studies have found this method improves exercise ability and appears safe. No major negative effects have been reported with this type of exercise training. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the one-legged cycle training for idiopathic pulmonary fibrosis because it offers a novel way to boost aerobic conditioning. Unlike the standard two-legged cycling, this method isolates each leg, potentially allowing for more targeted muscle engagement and improved endurance over time. By focusing on one leg at a time, participants can gradually increase intensity and duration, which might lead to better cardiovascular improvements and overall exercise tolerance, a crucial factor for individuals with this lung condition.

What evidence suggests that this trial's treatments could be effective for idiopathic pulmonary fibrosis?

This trial will compare one-legged cycle training with two-legged cycle training for individuals with idiopathic pulmonary fibrosis (IPF). Research has shown that cycling with one leg can greatly improve exercise performance in people with IPF. Studies have found that participants produce twice the work output when using one leg instead of both. This technique eases breathing by engaging fewer muscles at a time. Additionally, cycling with one leg can lead to better physical improvements over time. For those with lung conditions like IPF, this could result in better endurance and easier workouts. ^{1 2 3 6 7}

Who Is on the Research Team?

Roger Goldstein, MD, FRCPC

Principal Investigator

West Park Healthcare Centre

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 1-leg cycle training
• 2-leg cycle training

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+

Published Research Related to This Trial

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]

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]

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 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]

In a study involving 12 patients with severe chronic obstructive pulmonary disease (COPD), both hyperoxic and normoxic high-intensity interval training significantly improved peak oxygen uptake (V O (2peak), with increases of 24% and 15% respectively after 8 weeks of training.

Despite the improvements in V O (2peak) from both training conditions, using supplemental oxygen (hyperoxia) during training did not provide any additional benefits compared to training in normal air (normoxia).

NCBI (Pubmed)

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. Bjørgen, S., Helgerud, J., Husby, V., et al.[2009]

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]

General exercise training significantly improves quality of life in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) compared to standard care without pulmonary rehabilitation.

After a COPD exacerbation, exercise training can reduce the risk of hospitalization by at least 50% in the following months, and the overall harm-benefit balance of exercise training in COPD appears favorable based on available data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPD: benefits of exercise training. [2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6993799/

Cardiorespiratory Responses between One-legged and Two ... One-legged cycling partitions the targeted exercising muscle, thereby reducing the total ventilatory burden for the same muscle-specific power.

2. ctv.veeva.com ctv.veeva.com/study/partitioned-training-of-patients-with-idiopathic-pulmonary-fibrosis

Partitioned Training of Patients with Idiopathic Pulmonary ... Participants achieved double the work whilst exercising with one leg compared with two-legged cycle exercise. Partitioned training may therefore ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175616/

Single-leg cycling to maintain and improve function in healthy ... One reduced active muscle mass exercise that can promote greater positive physiological adaptations is single-leg cycling (SLC).

4. withpower.com withpower.com/trial/phase-lung-diseases-interstitial-2-2019-ae1c0

One-Legged vs Two-Legged Cycle Training for Idiopathic ... This trial aims to determine if exercising one leg at a time can improve exercise endurance in people with idiopathic pulmonary fibrosis (IPF) more ...

5. researchgate.net researchgate.net/publication/281170704_One-Legged_Cycle_Training_for_Chronic_Obstructive_Pulmonary_Disease_A_Pragmatic_Study_of_Implementation_to_Pulmonary_Rehabilitation

One-Legged Cycle Training for Chronic Obstructive ... We evaluated the feasibility of incorporating one-legged cycling as the principal aerobic training modality for pulmonary rehabilitation in COPD.

6. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1105772/full

Single-leg cycling to maintain and improve function in ... One reduced active muscle mass exercise that can promote greater positive physiological adaptations is single-leg cycling (SLC).

7. thorax.bmj.com thorax.bmj.com/content/70/Suppl_3/A143.2

P134 Exercise Responses to One-legged Cycling in ... Randomised controlled trials have shown greater improvements in exercise capacity after training using one-legged cycling (OLC) compared to two-legged cycling ( ...