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

NCT06479486 | Completed DMC

• 1 other identifier: Aimen Shahbaz
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Clinimetric properties, COPD, performance-based measures

Outcome Measures

Primary Outcomes (4)

• 6MWT (Six-Minute Walk Test)

  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)

  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)

  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):

  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

Study Arms (1)

Functionality Assessment

OTHER

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

Interventions

Assigned Interventions DIAGNOSTIC_TEST

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.

Also known as: Standardized pulmonary rehab protocols

Functionality Assessment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hearts International Hospital

Islamabad, AL, 44000, Pakistan

Location

Related Publications (2)

• Massierer D, Alsowayan W, Lima VP, Bourbeau J, Janaudis-Ferreira T. Prognostic value of simple measures of physical function and muscle strength in COPD: A systematic review. Respir Med. 2020 Jan;161:105856. doi: 10.1016/j.rmed.2019.105856. Epub 2019 Dec 19.

  PMID: 32056729 BACKGROUND

• Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91(1):8-35. doi: 10.1159/000521288. Epub 2022 Jan 6.

  PMID: 34991091 BACKGROUND

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

• Suman Sheraz, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)