Clinical trial NCT02200549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: pulmonary rehabilitation
inspiratory muscle training
exercise training
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Exercise Performance (composite outcome measure)
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Secondary outcomes:
measure: Health-related quality (composite outcome measure)
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
measure: inspiratory muscle function (composite outcome measure)
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
measure: Symptom Evaluation (composite outcome measure)
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Other outcomes:
measure: Depression and anxiety evaluation
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
measure: Composite outcomes
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
measure: Body Composition Monitor
timeFrame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical Universtiy
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital,Southern Medical Unversity
name: Xin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: