Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.

February 20, 2023 updated by: Riphah International University

Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients

To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.

Study Overview

Detailed Description

A review state that "Interstitial lung disease presents clinical features of exertional desaturation and a nonproductive cough. Patients with ILD have significantly reduced exercise capacity as manifested by a reduced maximum work load achieved during exercise, as well as a reduced maximal oxygen uptake VO2max." in previous studies Pulmonary rehabilitation is the use of exercise, education and behavioral interventions for diseases such as non-ILD restrictive lung disease, asthma, lung cancer, bronchiectasis , and pulmonary hypertension, pre and post op thoracic surgery patients.

Quality of life (QOL) as an individual's perception of contentment or satisfaction with life in areas he or she considers important, and we define health-related quality of life (HRQL) as an individual's perception of the impact of health (in all its many facets) on his or her quality of life. a study on pulmonary rehabilitation outcomes between individuals with chronic obstructive lung disease (COPD) and non-COPD disease and its impact on gender.

Study Type

Interventional

Enrollment (Anticipated)

20

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

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 43600
        • Pakistan Railway Hospital
        • Contact:
        • Principal Investigator:
          • Aleena Ashraf, MSPT(CPPT)*

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC<80%, and FEV1/FVC>70%

Exclusion Criteria:

  • Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Chest Physiotherapy
Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD
Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD
Experimental: Aerobic Training group

Supervised Conventional chest physiotherapy+ Aerobic training Conventional chest physiotherapy supervised (1st week) Then non supervised for 2nd to 6th week Warm-up (5 minutes) Breathing exercise and stepping Diaphragmatic Breathing exercise *15 Reps* TD

Aerobic training on cycle ergometer:

between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day Cool down (5 minutes) AROM +Body stretch

Supervised Conventional Chest Physiotherapy + Aerobic training

Aerobic training on cycle ergometer:

between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 3 weeks, 6 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
3 weeks, 6 weeks
Forced vital Capacity (FVC)
Time Frame: 3 weeks,6 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
3 weeks,6 weeks
Peak Expiratory Flow (PEF)
Time Frame: 3 weeks,6 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
3 weeks,6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of life
Time Frame: 3 weeks,6 weeks
Measured through St. George's Respiratory Questionnaire in its COPD-specific version (SGRQ-C). The SGRQ-C with 40 items provides three component scores for symptoms, activity and impact, and a total score. Each score ranges from 0 (no impairment) to 100 (worst possible). A difference of 4 unit points is considered the minimum clinically important difference (MCID).
3 weeks,6 weeks

Collaborators and Investigators

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

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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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