Back to resultsEffect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
Primary Purpose
COPD, Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physiotherapy Treatment
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
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.
Sites / Locations
- Pulmonary Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
Outcomes
Primary Outcome Measures
Six minute walk test
to measure distance walked in six minutes
Cough & sputum assessment questionnaire.
recall assesses the frequency and severity of cough and sputum and their impact on everyday life
Secondary Outcome Measures
leicester cough questionnaire
This questionnaire is designed to assess the impact of cough on various aspects of your life.
Full Information
NCT ID
NCT05538975
First Posted
September 8, 2022
Last Updated
September 12, 2022
Sponsor
Afridi Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05538975
Brief Title
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
Official Title
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum Expectoration in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
August 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afridi Medical Complex
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing
Intervention Type
Other
Intervention Name(s)
Physiotherapy Treatment
Intervention Description
Pulmonary Rehabilitation Techniques
Primary Outcome Measure Information:
Title
Six minute walk test
Description
to measure distance walked in six minutes
Time Frame
6 months
Title
Cough & sputum assessment questionnaire.
Description
recall assesses the frequency and severity of cough and sputum and their impact on everyday life
Time Frame
6 months
Secondary Outcome Measure Information:
Title
leicester cough questionnaire
Description
This questionnaire is designed to assess the impact of cough on various aspects of your life.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Alamdar Hussain, Phd
Organizational Affiliation
Afridi Medical Complex
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Rehabilitation
City
Peshawar
State/Province
KP
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
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