Clinimetric Properties of Performance-based Measures of Physical Function in Patients With COPD (COPD)

January 22, 2025 updated by: Riphah International University

Clinimetric Properties of Performance-based Measures of Physical Function in Patients With COPD: a Comparison of Clinimetric Properties of Four Tools

A COPD (Chronic obstructive pulmonary disease), is a group of progressive lung diseases. COPD is a preventable and treatable respiratory disorder largely caused by smoking and long term exposure to chemical irritants. This study aims to provide essential insights into the reliability, validity, responsiveness and Interpretability of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A COPD (Chronic obstructive pulmonary disease), is a group of progressive lung diseases, a preventable and treatable respiratory disorder largely caused by smoking and long term exposure to chemical irritants. COPD affects the respiratory system and is progressive, which can result in a number of difficulties or impairments. ) Effect on Daily Activities, Work Limitations, Fatigue Muscle Weakness, Breathlessness and Reduced Exercise Capacity, and Impaired Quality of Life. Pulmonary rehabilitation is a comprehensive course that helps people with chronic respiratory illnesses, such as COPD, improve their overall health and quality of life. Clinimetric properties of four distinct tools designed for assessing performance-based physical functional outcomes following COPD patients surgery. 6 Minute Walk Test (6MWT), 2 minute Walk test (2MWT), and Timed Up and GO (TUG), 30sec sit to stand test (30sec STS) will be assessed to determine any changes in their functionality test.

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Pakistan
    • AL
      • Islamabad, AL, Pakistan, 44000
        • Hearts International Hospital

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:

  • Diagnosed cases of COPD (FEV1/FVC < 0.70).
  • Both genders
  • Clinically stable
  • Age 40-65 years

Exclusion Criteria:

  • Disease exacerbation in last 4 weeks
  • Co-existing respiratory or any other condition
  • Inability to perform tests due to cognitive or any physical limitations

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Functionality Assessment
Each participant will be provided with an informed consent form detailing the purpose of the study. After obtaining written consent, baseline data will be collected, including demographic information, medical history, and any pre-existing conditions.The participants will then undergo the post-laparotomy interventions as described. Throughout the intervention period, data will be collected using the tools mentioned: 6 minute Walk Test, 30 seconds sit to stand test, 2 Minute walk Test, and Timed Up and GO to determine any changes in their functionality test .For reliability, test retest will be conducted both on day 1 and on the next day.
Diagnostic test: Assigned Interventions
warm up: global range of motion exercises; breathing control. Aerobic training: walking, cycling, stepping Resistance training: free weights(major muscle groups of upper and lower limbs and trunk Cool down; Breathing control and stretching exercises.
Other Names:
  • Standardized pulmonary rehab protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6MWT (Six-Minute Walk Test)
Time Frame: 6 week
A six-minute walk test to assess your fitness or functional condition. Using a pulse oximeter, the researchers will take your blood pressure, pulse, and oxygen saturation before you start walking. The following instructions will be given to participants. The competitors will walk as close to a chair or cone as they can for six minutes at their regular pace. After that, they will turn around and continue walking back and forth for an additional six minutes. It was shown that this test had good test-retest reliability.
6 week
2MWT (Two-Minute Walk Test)
Time Frame: 6 week
The 2MWT is a functional exercise test designed to evaluate an individual's aerobic capacity and endurance over a shorter duration compared to the 6MWT.
6 week
Timed Up and GO (TUG)
Time Frame: 6 week
It is designed to assess an individual's mobility and requires the participant to stand up from a seated position, walk a distance of three meters, turn around, walk back to the chair, and sit down.
6 week
30 seconds sit to stand test (30SSTS):
Time Frame: 6 week
Used to assess lower extremity strength, balance, and functional capacity in patients with chronic obstructive pulmonary disease (COPD). It involves measuring the number of times a patient can rise from a seated position to a full standing position and then return to sitting within a 30-second period. The test is typically conducted in a chair with a standardized height and armrest comapred TUG test
6 week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Suman Sheraz, PhD*, Riphah International University

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 15, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aimen Shahbaz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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