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

NCT02200549 | Completed DMC

• 1 other identifier: CX13902205193
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

pulmonary rehabilitation; inspiratory muscle training; exercise training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• Symptom Evaluation (composite outcome measure)

  The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

Other Outcomes (3)

• Depression and anxiety evaluation

  The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

• Composite outcomes

  The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

• Body Composition Monitor

  The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

Study Arms (3)

Control group

EXPERIMENTAL

Neither cycle training nor inspiratory muscle training.

Device: Control group

Cycle training group

EXPERIMENTAL

A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.

Device: calibrated cycle ergometer

Combined group

EXPERIMENTAL

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

Interventions

Control group DEVICE

Neither cycle training nor inspiratory muscle training.

Control group

calibrated cycle ergometer DEVICE

The most common device to proform cycle training is calibrated cycle ergometer.

Cycle training group

calibrated cycle ergometer and threshold loading device 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.

Combined group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xin Chen, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 25, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 18, 2017

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)