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

54 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Inclined Exercise for COPD?

Exercise, including inclined exercise, can help people with COPD (a lung disease that makes it hard to breathe) by improving their ability to exercise, reducing breathlessness, and enhancing their quality of life. Studies show that exercise training can lead to significant improvements in these areas, even though it doesn't reverse the lung damage caused by COPD. ^{1 2 3 4 5}

Is inclined exercise safe for people with COPD?

Research shows that aerobic exercise, including inclined exercise, is generally safe for people with COPD when done with proper screening and medical supervision. Some studies report minor issues like changes in blood pressure and heart rate, but no serious adverse events or fatalities have been noted. ^{2 6 7 8 9}

How does inclined exercise differ from other treatments for COPD?

Inclined exercise, such as downhill walking, is unique because it focuses on eccentric exercise, which can improve physical function and quality of life in COPD patients with less dyspnea (shortness of breath) and fatigue compared to traditional level walking. This approach may offer a more reliable way to achieve significant improvements in exercise tolerance. ^{3 10 11 12 13}

What is the purpose of this trial?

This study is designed to provide information regarding how to improve pulmonary rehabilitation for persons with chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation is an exercise program for COPD patients that is recommended and benefits some, but not all, patients. The question being studied in this trial is whether during an exercise program, walking on an incline might be better than walking on faster on a flat surface in training muscles so that patients might be less short of breath with exercise.

Research Team

Debra J. Romberger, MD

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise and chronic obstructive pulmonary disease: modest fitness gains pay big dividends. [2010]

2. Sweden pubmed.ncbi.nlm.nih.gov

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

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

Combining functional exercises with exercise training in COPD: a randomized controlled trial. [2022]

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

Long-Term Benefits of Pulmonary Rehabilitation in Patients With COPD: A 2-Year Follow-Up Study. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Is there any treatment other than drugs to alleviate dyspnea in COPD patients? [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. [2018]

7. Egypt pubmed.ncbi.nlm.nih.gov

Assessment of Aerobic Exercise Adverse Effects during COPD Exacerbation Hospitalization. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: respiratory disease. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

Downhill walking influence on physical condition and quality of life in patients with COPD: A randomized controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Exercise training in patients with COPD. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation and non-invasive ventilation in COPD. [2016]