Chronic Obstructive Pulmonary DiseaseNCT06240936
Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients
A study testing Active Cycle of breathing and Active Cycle of breathing with Acapella in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic Obstructive Pulmonary Disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Active Cycle of breathing and Active Cycle of breathing with Acapella
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2024to 15 Apr 2024
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both men and women age between 35-50 years.
- Having smoking history .(1)
- Dyspnea MRC scale grade 2 and grade 3.(20)
- Gold standard COPD grade 2
Who cannot join
- Any kind of infective pulmonary condition .
- Restrictive lung disease.(20)
- Pregnancy.
- Any severe heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients
Chronic Obstructive Pulmonary Disease refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. The symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. Due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. Patient will also feel breathless just sitting or relaxing. Active Cycle of breathing technique can be used to mobilize and clear secretions. It will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. Acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. A randomized control trial will be conducted at Gosha e Shifa hospital and General hospital Lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with active cycle of breathing exercises/techniques and Group B will be treated with Acapella device with active cycle of breathing exercise .Outcome measure will be conducted through Modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform Pulmonary function test .Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Active Cycle of breathing, Active Cycle of breathing with Acapella
- Keywords
- COPD, ACBTs, Acapella,, breathlessness, fatigue
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cycle of breathingOther
Active Cycle of Breathing Techniques will be given to group A. In Active cycle of breathing exercises, breathing control, thoracic expansion and forced expiration technique will be applied. 3-4 sets of exercise ,10-15 mint, 4 times per week for 4 weeks.
Active Cycle of breathing with AcapellaOther
Acapella device will be used along active cycle of breathing techniques to group B. 3-4 sets ,10 mints foe acapella training ,15 -20 munts ,4 times per week for 4 weeks.
This technique is active form of therapy in which patient uses its own energy on request to aid in treatment.
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Active comparator | ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. Receives: Other: Active Cycle of breathing |
| Active Cycle of breathing with Acapela | Experimental | ACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. The Acapella device is a handheld device used to help loosen mucus in the lungs. Sit up straight and hold the device in the upright position. Take a deep breath in and seal lips around the mouthpiece. Exhaleforcefully through the mouthpiece, using your stomach muscles to push the air out. Repeat this process several times, taking breaks. After using Acapella cough to clear any mucus that has been loosened. Clean the device after each use. Receives: Other: Active Cycle of breathing; Other: Active Cycle of breathing with Acapella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Dyspnea scale.
Data collection tool for shortness of breath is modified dyspnea scale there will be 10 readings. It also accesses breathing discomfort, sensory qualities and emotional distress.
Measured: baseline and fourth week
PFTs
The test will measure the lung volume, and ABGs. It is important tool for the investigation and monitoring of patients with respiratory pathology
Measured: baseline and fourth week
Sputum diary BCSS
In this diary we will check breathlessness, cough and sputum. It also includes the score of patient wellbeing and documented all minor symptoms
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha Younis, MSPT (CP), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240936
- Sponsor's protocol ID
- REC/RCR&AHS/23/0339
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anto JM, Vermeire P, Vestbo J, Sunyer J. Epidemiology of chronic obstructive pulmonary disease. Eur Respir J. 2001 May;17(5):982-94. doi: 10.1183/09031936.01.17509820.
PubMed 11488336Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
PubMed 32250871Lange P, Ahmed E, Lahmar ZM, Martinez FJ, Bourdin A. Natural history and mechanisms of COPD. Respirology. 2021 Apr;26(4):298-321. doi: 10.1111/resp.14007. Epub 2021 Jan 28.
PubMed 33506971
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Cycle of Breathing Techniques With and Without Acapella in COPD Patients
- ClinicalTrials.gov ID
- NCT06240936
- Acronym / sponsor ID
- REC/RCR&AHS/23/0339
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, ACBTs, Acapella,, breathlessness, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 Feb 2024 (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 refers to a group of progressive lung diseases the block air flow and make it difficult to breath. It is potentially fatal and fourth leading cause of death in the world. The symptoms of this condition include shortness of breath, frequent coughing, fatigued and tightness in the chest. Due to the secretions in the lungs sometime patients will have great difficulty catching the breath after walking or exercise. Patient will also feel breathless just sitting or relaxing. Active Cycle of breathing technique can be used to mobilize and clear secretions. It will improve their stamina and reduce the episodes of breathlessness, help to remove the secretions from the lungs and feel better overall. Acapella is a small hand held device which help to loosen and clear secretions from the chest it has both resistive and vibratory features. A randomized control trial will be conducted at Gosha e Shifa hospital and General hospital Lahore through convenience sampling technique on 42 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with active cycle of breathing exercises/techniques and Group B will be treated with Acapella device with active cycle of breathing exercise .Outcome measure will be conducted through Modified dyspnea scale, acapella device usage and questionnaire after 4 weeks and also perform Pulmonary function test .Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Acapella device uses and active cycle of breathing technique will be applied for comparing their effect in patients of COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Active comparator | Other: Active Cycle of breathingACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. |
| Active Cycle of breathing with Acapela | Experimental | Other: Active Cycle of breathing, Other: Active Cycle of breathing with AcapellaACBTs will be applied on the patients. It consist of the following three phases, breathing control,tboracic expension and forced expiration technique. The Acapella device is a handheld device used to help loosen mucus in the lungs. Sit up straight and hold the device in the upright position. Take a deep breath in and seal lips around the mouthpiece. Exhaleforcefully through the mouthpiece, using your stomach muscles to push the air out. Repeat this process several times, taking breaks. After using Acapella cough to clear any mucus that has been loosened. Clean the device after each use. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both men and women age between 35-50 years.
- Having smoking history .(1)
- Dyspnea MRC scale grade 2 and grade 3.(20)
- Gold standard COPD grade 2
Key exclusion criteria (4 listed)
- Any kind of infective pulmonary condition .
- Restrictive lung disease.(20)
- Pregnancy.
- Any severe heart disease
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 |
|---|---|---|
| Active Cycle of breathingActive Cycle of Breathing Techniques will be given to group A. In Active cycle of breathing exercises, breathing control, thoracic expansion and forced expiration technique will be applied. 3-4 sets of exercise ,10-15 mint, 4 times per week for 4 weeks. | Other | Active Cycle of breathing with Acapela, Active cycle of breathing technique |
| Active Cycle of breathing with AcapellaAcapella device will be used along active cycle of breathing techniques to group B. 3-4 sets ,10 mints foe acapella training ,15 -20 munts ,4 times per week for 4 weeks. This technique is active form of therapy in which patient uses its own energy on request to aid in treatment. | Other | Active Cycle of breathing with Acapela |
Primary outcome
Modified Dyspnea scale.
Time frame: baseline and fourth week
Data collection tool for shortness of breath is modified dyspnea scale there will be 10 readings. It also accesses breathing discomfort, sensory qualities and emotional distress.
PFTs
Time frame: baseline and fourth week
The test will measure the lung volume, and ABGs. It is important tool for the investigation and monitoring of patients with respiratory pathology
Sputum diary BCSS
Time frame: baseline and fourth week
In this diary we will check breathlessness, cough and sputum. It also includes the score of patient wellbeing and documented all minor symptoms
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 19 Apr 2024.
- Background: PubMed 11488336Anto JM, Vermeire P, Vestbo J, Sunyer J. Epidemiology of chronic obstructive pulmonary disease. Eur Respir J. 2001 May;17(5):982-94. doi: 10.1183/09031936.01.17509820.
- Background: PubMed 32250871Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
- Background: PubMed 33506971Lange P, Ahmed E, Lahmar ZM, Martinez FJ, Bourdin A. Natural history and mechanisms of COPD. Respirology. 2021 Apr;26(4):298-321. doi: 10.1111/resp.14007. Epub 2021 Jan 28.
- 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.
Madiha Younis, MSPT (CP) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cycle of breathing and Active Cycle of breathing with Acapella in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University 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 4 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 19 Apr 2024. 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. 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?
Modified Dyspnea scale. (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240936, which also lists 3 linked publications.
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 19 Apr 2024.