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

Study Overview
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Brief Summary
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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
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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: Cycle training program alone (performing on calibrated stationary cycle ergometer). Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device). Neither cycle training nor inspiratory muscle training.

Official Title
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Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Control group
* Device: calibrated cycle ergometer
* Device: calibrated cycle ergometer and threshold loading device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>Neither cycle training nor inspiratory muscle training. | Device: Control group<br>* Neither cycle training nor inspiratory muscle training.<br>|
| Experimental: Cycle training group<br>A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer. | Device: calibrated cycle ergometer<br>* The most common device to proform cycle training is calibrated cycle ergometer.<br>|
| Experimental: Combined group<br>A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device. | Device: calibrated cycle ergometer and threshold loading device<br>* Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality (composite outcome measure) | 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. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) | 
| inspiratory muscle function (composite outcome measure) | Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) | 
| Symptom Evaluation (composite outcome measure) | 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). | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary rehabilitation, inspiratory muscle training, exercise training