Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: Control group; Device: calibrated cycle ergometer; Device: calibrated cycle ergometer and threshold loading device

• Registration Number: NCT02200549
• Lead Sponsor: Zhujiang Hospital

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.

Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.

There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.

Detailed Description

The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:

1. Cycle training program alone (performing on calibrated stationary cycle ergometer).

2. Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).

3. Neither cycle training nor inspiratory muscle training.

Study Timeline

• Study First Submitted: 2014-07-20
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-12
• Status Verified: 2016-03
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients between 40 and 75 years of age were eligible if they met the following criteria:

  • moderate to severe airflow obstruction (30≤ Forced Expiratory Volume At One Second(FEV1) <80% predicted and Forced Expiratory Volume At One Second/Forced Vital Capacity(FEV1/FVC)<70%)
  • Complaints of dyspnea on exertion
  • Clinically stable condition
  • No participation in a pulmonary rehabilitation program in the last year.

Exclusion Criteria

• Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment
• Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise
• And/or had other health problems that would interfere with exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Neither cycle training nor inspiratory muscle training.
Cycle training group	calibrated cycle ergometer	A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
Combined group	calibrated cycle ergometer and threshold loading device	A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.

Primary Outcome Measures

Name	Time	Method
Exercise Performance (composite outcome measure)	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)	Exercise performance tests include field walking tests and cycle ergometer tests.

Secondary Outcome Measures

Name	Time	Method
Health-related quality (composite outcome measure)	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)	Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.
inspiratory muscle function (composite outcome measure)	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)	Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.
Symptom Evaluation (composite outcome measure)	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)	Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).

Trial Locations

Locations (1)

Zhujiang Hospital,Southern Medical Universtiy; 🇨🇳 Guangzhou, Guangdong, China