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

NCT ID: NCT06479486

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Assigned Interventions

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Standardized pulmonary rehab protocols

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suman Sheraz, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Hearts International Hospital

Islamabad, AL, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 32056729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34991091 (View on PubMed)

Other Identifiers

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Aimen Shahbaz

Identifier Type: -

Identifier Source: org_study_id

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