COPDNCT05538975
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
A study testing Physiotherapy Treatment in people with COPD and Pulmonary Disease, run by Afridi Medical Complex at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Pulmonary Disease
- What is being tested?
- Physiotherapy Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2022to 21 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 40 to 60
- Gender: Both Males \& Females.
- Diagnoses with an exacerbation of COPD.
- Informed consent obtained.
Who cannot join
- Inability to provide informed consent or complete a self-administered questionnaire.
- Patients with trauma.
- Females who were pregnant and breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Pulmonary Disease
- Being tested
- Physiotherapy Treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy TreatmentOther
Pulmonary Rehabilitation Techniques
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing Receives: Other: Physiotherapy Treatment |
| Group B | Placebo comparator | Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing Receives: Other: Physiotherapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
to measure distance walked in six minutes
Measured: 6 months
Cough & sputum assessment questionnaire.
recall assesses the frequency and severity of cough and sputum and their impact on everyday life
Measured: 6 months
Secondary outcomes (1)
leicester cough questionnaire
This questionnaire is designed to assess the impact of cough on various aspects of your life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start23 Feb 2022
- Primary completion28 Jul 2022
- Study completion21 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afridi Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usman Farooq, Afridi Medical Complex
- Investigators
- Syed Alamdar Hussain, Phd, Study director, Afridi Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538975
- Sponsor's protocol ID
- 0112
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum Expectoration in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05538975
- Acronym / sponsor ID
- 0112
- Conditions
- COPD, Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Afridi Medical ComplexUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Physiotherapy Treatmenthome based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing |
| Group B | Placebo comparator | Other: Physiotherapy TreatmentSupervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 40 to 60
- Gender: Both Males \& Females.
- Diagnoses with an exacerbation of COPD.
- Informed consent obtained.
Key exclusion criteria (3 listed)
- Inability to provide informed consent or complete a self-administered questionnaire.
- Patients with trauma.
- Females who were pregnant and breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy TreatmentPulmonary Rehabilitation Techniques | Other | Group A, Group B |
Primary outcome
Six minute walk test
Time frame: 6 months
to measure distance walked in six minutes
Cough & sputum assessment questionnaire.
Time frame: 6 months
recall assesses the frequency and severity of cough and sputum and their impact on everyday life
1 secondary outcome
leicester cough questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Alamdar Hussain, Phd study director
Afridi Medical Complex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Treatment in people with COPD and Pulmonary Disease, run by Afridi Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.