- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538975
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
September 12, 2022 updated by: Usman Farooq, Afridi Medical Complex
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum Expectoration in Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD)is a multifactorial, progressive chronic lung disease that causes airflow restriction.
Study was conducted To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease.
It was a randomised control trial and participants were COPD Patients.
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
KP
-
Peshawar, KP, Pakistan
- Pulmonary Rehabilitation
-
-
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
36 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 40 to 60
- Gender: Both Males & Females.
- Diagnoses with an exacerbation of COPD.
- Informed consent obtained.
Exclusion Criteria:
- Inability to provide informed consent or complete a self-administered questionnaire.
- Patients with trauma.
- Females who were pregnant and breastfeeding.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
|
Pulmonary Rehabilitation Techniques
|
|
Placebo Comparator: Group B
Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
|
Pulmonary Rehabilitation Techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six minute walk test
Time Frame: 6 months
|
to measure distance walked in six minutes
|
6 months
|
|
Cough & sputum assessment questionnaire.
Time Frame: 6 months
|
recall assesses the frequency and severity of cough and sputum and their impact on everyday life
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
leicester cough questionnaire
Time Frame: 6 months
|
This questionnaire is designed to assess the impact of cough on various aspects of your life.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Syed Alamdar Hussain, Phd, Afridi Medical Complex
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 (Actual)
February 23, 2022
Primary Completion (Actual)
July 28, 2022
Study Completion (Actual)
August 21, 2022
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 12, 2022
First Posted (Actual)
September 14, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 12, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0112
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
product manufactured in and exported from the U.S.
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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