The Effects of Positive Expiratory Pressure Breathing on The Rate of Post-exercise Recovery in Patients With COPD

NCT02398071 | Unknown DMC

• 1 other identifier: Khon Kaen University
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Most daily activities involve alternating periods of exercise and rest. If recovery is slow following exercise it means that the next period of activity may be more difficult and the COPD patients becomes restricted in their daily life. Therefore, the investigators are interested to study the effectiveness and physiological effects of breathing with a PEP device during post-exercise period and hypothesize that

1. 1.Post-exercise breathing with PEP device will increase the rate of recovery more than breathing without PEP device.
2. 2.Post-exercise breathing with PEP device will not create harmful effects on cardiopulmonary function in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Positive Expiratory Pressure; Exercise Recovery; COPD

Outcome Measures

Primary Outcomes (1)

• Dyspnea rating (Rating of Perceived Breathlessness)

  collect data every minute

  5 minutes of exercise, 10 minutes of recovery periods

Secondary Outcomes (8)

• Oxygen pulse saturation (SpO2)

  5 minutes of exercise, 10 minutes of recovery periods

• End tidal carbon dioxide pressure (PETCO2)

  5 minutes of exercise and 10 minutes of recovery periods

• Respiratory rate (RR)

  5 minutes of exercise, 10 minutes of recovery periods

• Expiratory flow rate

  10 minutes of recovery periods

• Mouth pressure

  10 minutes of recovery periods

Study Arms (2)

PEP interventon

EXPERIMENTAL

Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 5 cmH2O

Device: A water pressure threshold device (BreatheMAX)

Sham intervention

SHAM COMPARATOR

Participants performed 6 PEP breaths using a water pressure threshold device (BreatheMAX) with expiratory load set at 0 cmH2O

Device: A water pressure threshold device (BreatheMAX)

Interventions

A water pressure threshold device (BreatheMAX) DEVICE

BreatheMAX®, the water pressure threshold breathing device contributed in our laboratory will be used. This device is small, simple, easy to use and also inexpensive since the device is developed and manufactured in Thailand. The depth of water in the body of the device provides the flow resistance during exhalation through the inlet tube in a water cylinder.

PEP interventon; Sham intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate to severe COPD (both stages: FEV1/FVC \< 70%, moderate stage: 50% ≤ FEV1 \< 80% predicted, severe stage: 30% ≤ FEV1 \< 50% predicted according to Global Initiative Obstructive Lung Disease (GOLD) guideline
• Free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or ER or unscheduled clinic visit)
• Age between 40-70 years old
• Good communication

You may not qualify if:

• Musculoskeletal problems that limit mobility
• Cardiovascular disease
• Neurological or psychiatric illness
• Any other comorbidities which would affect ability to undertake exercise test

Sponsors & Collaborators

• Khajonsak Pongpanit: lead

Study Sites (1)

School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University

Khon Kaen, Muang Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Chulee Jones, PhD

  School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

  STUDY DIRECTOR

• Watchara Boonsawat, PhD

  Department of medicine, Faculty of medicine, Khon Kaen university, Thailand

  STUDY CHAIR

• David A. Jones, PhD

  School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, United Kingdom

  STUDY CHAIR

• Khajonsak Pongpanit, MSc student

  School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khajonsak Pongpanit, MSc student

CONTACT

+66832032415; p.khajonsak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate School, Khon Kaen university

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 25, 2015
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

TH (1)