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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Control group; Device: calibrated cycle ergometer; Device: calibrated cycle ergometer and threshold loading device

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Neither cycle training nor inspiratory muscle training.	Device: Control group; Neither cycle training nor inspiratory muscle training.
Experimental: Cycle training group; A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.	Device: calibrated cycle ergometer; The most common device to proform cycle training is calibrated cycle ergometer.
Experimental: Combined group; 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; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 20, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; inspiratory muscle training; exercise training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
• Other Study ID Numbers: CX13902205193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No