Inclined Exercise for COPD

Overseen By Farahnaz Fallahtafti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Mood, Metabolic

Disqualifiers: Neurological, Musculoskeletal, Metabolic, others

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

Compensation: Varies

Number of Visits: 39

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve exercise programs for individuals with chronic obstructive pulmonary disease (COPD), a lung condition that makes breathing difficult. Researchers aim to determine if inclined exercise is more effective than faster walking on a flat surface for improving breathing during exercise. The trial seeks participants with COPD who are physically stable but struggle with daily activities due to breathing problems. Participants should not have other health issues affecting walking or require oxygen masks during rest or activity. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative exercise strategies that could enhance daily life for those with COPD.

Will I have to stop taking my current medications?

If you are taking medications that alter mood or metabolic demand, you will not be able to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that inclined exercise is safe for COPD patients?

Research shows that walking uphill can be a safe exercise for people with COPD, a lung disease that makes breathing difficult. Studies have found that exercise, including walking on an incline, can improve quality of life and reduce shortness of breath for those with stable COPD. Most people with COPD can handle this type of exercise well.

Regarding walking faster, research indicates that speed can affect daily functioning and overall quality of life for people with COPD. Although walking faster might be more challenging, it is generally safe and can enhance physical fitness.

Both uphill and faster walking offer proven benefits and are usually safe for people with COPD. However, consulting a doctor before starting any new exercise routine is essential to ensure it is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Inclined Exercise for COPD trial because it explores how different treadmill settings could benefit people with COPD, a condition traditionally managed by medications like bronchodilators and corticosteroids. The trial compares two unique exercises: walking at an incline versus walking at a specific speed, both tailored to 60% of a person's peak heart rate. This approach could reveal how altering treadmill settings affects lung function and overall health, potentially offering a more accessible, non-drug way to manage COPD symptoms and improve quality of life.

What evidence suggests that inclined exercise might be an effective treatment for COPD?

Research has shown that exercise, such as walking uphill, can greatly enhance the quality of life and physical ability for people with COPD. It also helps reduce shortness of breath. In this trial, participants will follow different exercise regimens. One group will walk at an incline, which may strengthen muscles and improve breathing more effectively than walking faster on flat ground. Another group will focus on walking at a specific speed. Studies on walking speed reveal that people with COPD often take slower steps and find breathing more difficult, but regular exercise can help. Both exercise types in this trial aim to improve physical fitness and overall function for those with COPD. ^{1 2 4 6 7}

Who Is on the Research Team?

Debra J. Romberger, MD

Principal Investigator

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Are You a Good Fit for This Trial?

This trial is for people with chronic obstructive pulmonary disease (COPD). Participants should be able to attend 36 exercise sessions. Specific eligibility details are not provided, but typically, patients must meet certain health criteria and may need a doctor's approval.

Inclusion Criteria

My lung function tests show moderate to severe restriction.

I will have a lung function test after taking medicine to open my airways.

Subjects with qualifying spirometry will be screened further

Exclusion Criteria

I do not have neurological, musculoskeletal, or metabolic diseases.

I need an oxygen mask for breathing at rest or during activities.

I am not on medications that affect my mood or metabolism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 12-week pulmonary rehabilitation program with either inclined or standard treadmill walking

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inclined Exercise

Trial Overview The study compares two types of exercises: walking on an incline vs. walking at increasing speeds on a flat surface. It aims to determine which method better improves muscle training and reduces breathlessness during physical activity in COPD patients.

How Is the Trial Designed?

Group I: Walking at Speed Experimental Treatment 1 Intervention

Subjects will walk on treadmill at speed equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test.

Group II: Walking at Incline Experimental Treatment 1 Intervention

Subjects will walk on treadmill at slope equal to 60% of their peak heart rate as determined on baseline cardiopulmonary exercise test.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

A new physical activity education program (EDU) for COPD patients was found to be as effective and safe as traditional combined strength-endurance training (CT) in improving health-related factors like walking capacity and quality of life over a 28-week training period.

Both EDU and CT showed improvements in health parameters, but these benefits were not sustained after a 14-week follow-up, indicating the need for ongoing physical activity to maintain gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. Rinaldo, N., Bacchi, E., Coratella, G., et al.[2018]

A systematic review of 20 studies involving 2018 hospitalized adults with respiratory conditions found that exercise programs, including aerobic and resistance training, were generally well tolerated and had infrequent adverse events, with only seven reported across 7420 training sessions.

The exercise programs varied widely in their design and implementation, with some using objective measures to tailor the initial sessions, highlighting the need for standardized approaches in prescribing exercise for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review. Rice, H., Harrold, M., Fowler, R., et al.[2022]

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]

Aerobic exercise initiated 72 hours after hospitalization in 11 patients with exacerbated COPD was found to be safe, with significant increases in systolic blood pressure and respiratory rate during the activity.

Despite a decrease in oxygen saturation levels during exercise, the overall vital signs indicated that patients could tolerate the intensity, reaching an average of 76% of their maximum heart rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Aerobic Exercise Adverse Effects during COPD Exacerbation Hospitalization. Knaut, C., Mesquita, CB., Caram, LM., et al.[2018]

Citations

1. withpower.com withpower.com/trial/inclined-exercise-for-copd-be327

Inclined Exercise for COPD · Info for Participants Exercise training significantly improves quality of life, physical capacity, and reduces dyspnea in individuals with stable chronic obstructive pulmonary ...

2. ctv.veeva.com ctv.veeva.com/study/uphill-walking-as-exercise-for-copd-patients

Uphill Walking as Exercise for COPD Patients The question being studied in this trial is whether walking on an incline might be better than walking on faster on a flat surface in training ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949916X23000129

Eccentric exercise as an innovative approach in chronic ... These exercise programs were shown to have a positive impact on physical fitness, quality of life and functionality of COPD patients. In addition, it was noted ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9354440/

Physical activity and chronic obstructive pulmonary disease Conversely, physical inactivity is a major risk factor for poor outcomes in people with COPD and also leads to early mortality death in patients ...

5. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1668559/pdf

Evaluating the physiological responses to treadmill ... Objectives: To compare physiological responses during treadmill exercise, based on 6 MWT results, across COPD severity levels per Global ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32444407/

Effects of downhill walking in pulmonary rehabilitation for ... This study compared the effect of pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06283004

Investigation of Walking Training With Different Slope ... Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in ...