In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise

NCT06332820 | Active Not Recruiting

• 1 other identifier: 202401226RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease.

Conditions

Obstructive Airway Disease

Keywords

Obstructive airway disease; Cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• Inspiratory capacity during exercise

  Inspiratory capacity during exercise

  During the cardiopulmonary exercise test

Secondary Outcomes (1)

• Change of FEV1 and symptoms

  During the cardiopulmonary exercise test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstructive airway disease patients

You may qualify if:

• Age \> 18

You may not qualify if:

• Coronary angiography via femoral artery in recent 3 days
• Central venous catheter in femoral vein
• The patient couldn't walk over 20 meters
• Lower limb arthropathy
• Unclear consciousness and the patient couldn't cooperate well
• SPO2 \< 85%
• Acute coronary syndrome in recent 1 month
• Respiratory failure or unstable hemodynamics
• Pneumothorax or bronchial fistula
• Acute exacerbation in recent 3 months

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ting-Yu Liao

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 19, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)