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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Control group
calibrated cycle ergometer
calibrated cycle ergometer and threshold loading device
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring pulmonary rehabilitation, inspiratory muscle training, exercise training

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhujiang Hospital,Southern Medical Universtiy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control group

Cycle training group

Combined group

Arm Description

Neither cycle training nor inspiratory muscle training.

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

A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.

Outcomes

Primary Outcome Measures

Exercise Performance (composite outcome measure)
Exercise performance tests include field walking tests and cycle ergometer tests.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
July 20, 2014
Last Updated
May 16, 2017
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02200549
Brief Title
Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
pulmonary rehabilitation, inspiratory muscle training, exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Neither cycle training nor inspiratory muscle training.
Arm Title
Cycle training group
Arm Type
Experimental
Arm Description
A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
Arm Title
Combined group
Arm Type
Experimental
Arm Description
A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
Neither cycle training nor inspiratory muscle training.
Intervention Type
Device
Intervention Name(s)
calibrated cycle ergometer
Intervention Description
The most common device to proform cycle training is calibrated cycle ergometer.
Intervention Type
Device
Intervention Name(s)
calibrated cycle ergometer and threshold loading device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise Performance (composite outcome measure)
Description
Exercise performance tests include field walking tests and cycle ergometer tests.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Secondary Outcome Measure Information:
Title
Health-related quality (composite outcome measure)
Description
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.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Title
inspiratory muscle function (composite outcome measure)
Description
Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax),expiratory pressures(PEmax) and inspiratory muscle endurance.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Title
Symptom Evaluation (composite outcome measure)
Description
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).
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Other Pre-specified Outcome Measures:
Title
Depression and anxiety evaluation
Description
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.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Title
Composite outcomes
Description
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.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Title
Body Composition Monitor
Description
Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
Time Frame
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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