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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200549
• Other study ID #: CX13902205193
• Status: Completed
• Phase: N/A
• First received: July 20, 2014
• Last updated: May 16, 2017
• Start date: December 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2016
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Device:
• Control group
Neither cycle training nor inspiratory muscle training.
• calibrated cycle ergometer
The most common device to proform cycle training is calibrated cycle ergometer.
• calibrated cycle ergometer and threshold loading device
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.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression and anxiety evaluation	Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Other	Composite outcomes	Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index.	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Other	Body Composition Monitor	Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.	The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Primary	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	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)
Secondary	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)
Secondary	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)