- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174741
Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.
Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 43600
- Pakistan Railway Hospital
-
Contact:
- Mehwish Waseem, MSPT(CPPT)
- Phone Number: 03315309015
- Email: mehwish.waseem@riphah.edu.pk
-
Principal Investigator:
- Aleena Ashraf, MSPT(CPPT)*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rec/00882 Aleena Ashraf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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