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

Zhujiang Hospital

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Control group; Device: calibrated cycle ergometer and threshold loading device; Device: calibrated cycle ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02200549

CX13902205193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control group

Experimental group

Description:

Neither cycle training nor inspiratory muscle training.

Treatment:

Device: Control group

Cycle training group

Experimental group

Description:

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

Treatment:

Device: calibrated cycle ergometer

Combined group

Experimental group

Description:

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

Treatment:

Device: calibrated cycle ergometer and threshold loading device