Effect of Elastic Chest Compression on Functional Exercise Capacity and Respiratory Performance in Patients With COPD

July 19, 2024 updated by: National Taiwan University Hospital

The goal of this clinical trial is to investigate the effects of elastic chest compression on functional exercise capacity and respiratory performance of patients with COPD. The main questions it aims to answer are:

Is there difference in functional exercise capacity and respiratory performance without or with the use of elastic upper chest compression? Is there difference in functional exercise capacity and respiratory performance between the use of elastic upper chest compression and elastic lower chest compression?

Participants will:

Be evaluated under three conditions on three different days: without elastic compression, with upper chest compression, and with lower chest compression, with the order of compression application randomly assigned.

The functional capacity and respiratory muscle performance of all patients will be evaluated.

The days for evaluation will be at least three days apart from each other.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be evaluated under three conditions: without elastic compression, with upper chest compression, and with lower chest compression, with the order of compression application randomly assigned. A Red Theraband will be used to apply compression to the upper and lower regions of the chest. For a standardized approach to apply compression, the top edge will be aligned with the 3rd intercostal space for the upper chest compression, while the central horizontal part will line up with the xiphoid process of the sternum for the lower chest compression. After exhaling to the EELV, the circumferences of the upper and lower chest regions will be measured, using the 3rd intercostal space as the measurement mark for the upper chest and the xiphoid process of the sternum as the measurement marks for the lower chest. The Thera-Band will be adjusted to 90% of the measured circumferences, ensuring it is securely fastened and standardized resistance is applied consistently to the thoracic regions of interest throughout the study. After chest compression is applied, participants will undergo measurements for functional exercise capacity and respiratory muscle performance.

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Recruiting
        • National Taiwan University Hospital Hsinchu branch
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • at least 20 years old
  • has a clinical diagnosis of COPD without infection or acute exacerbation in the previous four weeks
  • is capable of cooperating with the required tests and measurements of the study

Exclusion Criteria:

  • has any clinical diagnosis that could affect test outcomes (e.g., neuromyopathy)
  • has experienced unstable angina or an acute myocardial infarction within the last month
  • has adjusted COPD related medication within the last month
  • a Mini-Mental State Examination (MMSE) score below 24

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper chest compression
The Theraband will be wrapped around the subject's upper chest with upper edge of the Theraband aligned to the 3rd intercostal space and fastened on the upper rib cage for the upper chest compression arm.
Device: Theraband chest compression
Chest compression applicated via a Red Theraband over the upper or lower chest region
Experimental: Lower chest compression
The Theraband will be wrapped around the subject's lower rib cage by placing the central horizontal part of the Theraband at the xiphoid process of the sternum for the lower chest compression arm.
Device: Theraband chest compression
Chest compression applicated via a Red Theraband over the upper or lower chest region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: up to 3 weeks
6 minute walk test measured in meters
up to 3 weeks
Respiratory muscle performance
Time Frame: up to 3 weeks
Maximum inspiratory (MIP) and expiratory pressures (MEP) in mmH2O
up to 3 weeks
Respiratory flow performance
Time Frame: up to 3 weeks
peak inspiratory (PIFR) and expiratory flows (PEFR) in liter per minute
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202405096RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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