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Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.

Primary Purpose

Pneumonia, Pulmonary Fibrosis, Tuberculosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Chest Physiotherapy
Aerobic training Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring non-COPD, quality of life, pulmonary function

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pakistan railway hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Chest Physiotherapy

Aerobic Training group

Arm Description

Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Health related Quality of life
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).

Full Information

First Posted
June 21, 2021
Last Updated
February 20, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05174741
Brief Title
Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.
Official Title
Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pulmonary Fibrosis, Tuberculosis, Bronchiectasis, Asthma
Keywords
non-COPD, quality of life, pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Chest Physiotherapy
Arm Type
Active Comparator
Arm Description
Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD
Arm Title
Aerobic Training group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD
Intervention Type
Other
Intervention Name(s)
Aerobic training Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
3 weeks, 6 weeks
Title
Forced vital Capacity (FVC)
Description
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
3 weeks,6 weeks
Title
Peak Expiratory Flow (PEF)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Time Frame
3 weeks,6 weeks
Secondary Outcome Measure Information:
Title
Health related Quality of life
Description
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).
Time Frame
3 weeks,6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan railway hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Phone
03315309015
Email
mehwish.waseem@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aleena Ashraf, MSPT(CPPT)*

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.

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