Chronic Obstructive Pulmonary DiseaseNCT05424133
ACBT and High Frequency Chest Wall Oscillations in COPD Patients
A study testing High frequency chest wall oscillation and Active cycle of breathing in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic obstructive pulmonary disease (COPD) patients with mucus hyper secretion tend to demonstrate increased frequency of infective exacerbations and a steeper slope of decline in lung function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High frequency chest wall oscillation and Active cycle of breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with clear consciousness ,stable vital sign, and ability to cooperate
- Stage 3-4 COPD according to GOLD criteria
- Adult patients
- Patient who had given informed consent
Who cannot join
- Need for invasive mechanical ventilation
- Active lung tuberculosis
- Chest wall trauma
- Thoracic or abdominal operations in last three months.
- Presence of cardiac pacemaker, artificial stunt or heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Active Cycle of Breathing Technique and High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease Patients
Chronic obstructive pulmonary disease (COPD) patients with mucus hyper secretion tend to demonstrate increased frequency of infective exacerbations and a steeper slope of decline in lung function. Enhanced mucosal clearance with high frequency chest wall oscillation (HFCWO) devices previously used in cystic fibrosis and bronchiectasis patients may offer the opportunity for community based, self-managed therapy to improve quality of life and lung function. The aim of this study is to compare effects of active cycle of breathing and high frequency chest wall oscillations in chronic obstructive pulmonary disease .This study will be a Randomized Clinical trial and will be conducted at Physical Therapy Department of DHQ Hospital NAROWAL. The study will be completed within the time duration of six months. Consecutive sampling technique will be used to collect the data. A sample size of Total 42 patients will be taken in this study. Patients will be divided into two groups. BODE Index will be used as outcome measurement tool. Group A will receive the Active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes. Group B will receive high frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks. The collected data will be analyzed on SPSS - 25.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High frequency chest wall oscillation, Active cycle of breathing
- Keywords
- Chest wall oscillation, Respiration, Pulmonary disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency chest wall oscillationOther
High frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks.
Active cycle of breathingOther
Active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Experimental | Group A will receive Active cycle of breathing technique with routine chest physiotherapy. Receives: Other: Active cycle of breathing |
| High frequency chest wall oscillation | Active comparator | Group B will receive High frequency chest wall oscillations with routine chest physiotherapy Receives: Other: High frequency chest wall oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BODE Index
The BODE index is a tool that is used by healthcare professionals to predict the mortality rate from chronic obstructive pulmonary disease (COPD) The final score of the BODE index ranges from 0 to 10 points; higher the index value, the worse is the patient's condition. The participants were divided into four quartiles for the analysis according to their BODE index score, Quartile I is a score of 0-2 points, quartile II 3-4 points, quartile III v 5-6 points, and quartile IV is a score of 7-10 points.
BODE Index Scale score at baseline and 4th week
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Mar 2022
- Primary completion15 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424133
- Sponsor's protocol ID
- REC/RCR & AHS/22/0321
- Status last verified
- Jan 2023
- First submitted
- 23 May 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen M, Li Y, Ding X, Xu L, Li F, Lin H. Effect of active cycle of breathing techniques in patients with chronic obstructive pulmonary disease: a systematic review of intervention. Eur J Phys Rehabil Med. 2020 Oct;56(5):625-632. doi: 10.23736/S1973-9087.20.06144-4. Epub 2020 May 13.
PubMed 32397703Barto TL, Maselli DJ, Daignault S, Stiglich J, Porter J, Kraemer C, Hansen G. Real-life experience with high-frequency chest wall oscillation vest therapy in adults with non-cystic fibrosis bronchiectasis. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620932508. doi: 10.1177/1753466620932508.
PubMed 32538317Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.
PubMed 29785100Weycker D, Hansen GL, Seifer FD. Outcomes with high-frequency chest wall oscillation among patients with non-CF bronchiectasis or COPD. American Thoracic Society. 2017. 7. Sievert CE, Beaner BCA, Sievert C. Using High Frequency Chest Wall Oscillation in a Bronchiectasis Patient Population: An Outcomes-Based Case Review. Respiratory Therapy. 2016;10:01.
Allam NM, Badawy MM. Does High-Frequency Chest Wall Oscillation Have an Impact on Improving Pulmonary Function in Patients With Smoke Inhalation Injury? J Burn Care Res. 2021 Mar 4;42(2):300-304. doi: 10.1093/jbcr/iraa147.
PubMed 32860696Gonzalez-Bellido V, Velaz-Baza V, Blanco-Moncada E, Del Carmen Jimeno Esteo M, Cuenca-Zaldivar JN, Colombo-Marro A, Donadio MVF, Torres-Castro R. Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis. Respir Care. 2021 Mar;66(3):425-433. doi: 10.4187/respcare.08177. Epub 2020 Nov 3.
PubMed 33144386Shen MD, Guo LR, Li YW, Gao RT, Sui X, Du Z, Xu LQ, Shi HY, Ni YY, Zhang X, Pang Y, Zhang W, Yu TZ, Li F. Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial. Trials. 2021 Mar 23;22(1):228. doi: 10.1186/s13063-021-05184-x.
PubMed 33757568
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Active Cycle of Breathing Technique and High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05424133
- Acronym / sponsor ID
- REC/RCR & AHS/22/0321
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chest wall oscillation, Respiration, Pulmonary disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 21 Jun 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) patients with mucus hyper secretion tend to demonstrate increased frequency of infective exacerbations and a steeper slope of decline in lung function. Enhanced mucosal clearance with high frequency chest wall oscillation (HFCWO) devices previously used in cystic fibrosis and bronchiectasis patients may offer the opportunity for community based, self-managed therapy to improve quality of life and lung function. The aim of this study is to compare effects of active cycle of breathing and high frequency chest wall oscillations in chronic obstructive pulmonary disease .This study will be a Randomized Clinical trial and will be conducted at Physical Therapy Department of DHQ Hospital NAROWAL. The study will be completed within the time duration of six months. Consecutive sampling technique will be used to collect the data. A sample size of Total 42 patients will be taken in this study. Patients will be divided into two groups. BODE Index will be used as outcome measurement tool. Group A will receive the Active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes. Group B will receive high frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks. The collected data will be analyzed on SPSS - 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Experimental | Other: Active cycle of breathingGroup A will receive Active cycle of breathing technique with routine chest physiotherapy. |
| High frequency chest wall oscillation | Active comparator | Other: High frequency chest wall oscillationGroup B will receive High frequency chest wall oscillations with routine chest physiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with clear consciousness ,stable vital sign, and ability to cooperate
- Stage 3-4 COPD according to GOLD criteria
- Adult patients
- Patient who had given informed consent
Key exclusion criteria (5 listed)
- Need for invasive mechanical ventilation
- Active lung tuberculosis
- Chest wall trauma
- Thoracic or abdominal operations in last three months.
- Presence of cardiac pacemaker, artificial stunt or heart failure
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 |
|---|---|---|
| High frequency chest wall oscillationHigh frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks. | Other | High frequency chest wall oscillation |
| Active cycle of breathingActive cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes | Other | Active cycle of breathing technique |
Primary outcome
BODE Index
Time frame: 4th week
The BODE index is a tool that is used by healthcare professionals to predict the mortality rate from chronic obstructive pulmonary disease (COPD) The final score of the BODE index ranges from 0 to 10 points; higher the index value, the worse is the patient's condition. The participants were divided into four quartiles for the analysis according to their BODE index score, Quartile I is a score of 0-2 points, quartile II 3-4 points, quartile III v 5-6 points, and quartile IV is a score of 7-10 points. BODE Index Scale score at baseline and 4th week
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 5 Jan 2023.
- Background: PubMed 32397703Shen M, Li Y, Ding X, Xu L, Li F, Lin H. Effect of active cycle of breathing techniques in patients with chronic obstructive pulmonary disease: a systematic review of intervention. Eur J Phys Rehabil Med. 2020 Oct;56(5):625-632. doi: 10.23736/S1973-9087.20.06144-4. Epub 2020 May 13.
- Background: PubMed 32538317Barto TL, Maselli DJ, Daignault S, Stiglich J, Porter J, Kraemer C, Hansen G. Real-life experience with high-frequency chest wall oscillation vest therapy in adults with non-cystic fibrosis bronchiectasis. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620932508. doi: 10.1177/1753466620932508.
- Background: PubMed 29785100Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.
- BackgroundWeycker D, Hansen GL, Seifer FD. Outcomes with high-frequency chest wall oscillation among patients with non-CF bronchiectasis or COPD. American Thoracic Society. 2017. 7. Sievert CE, Beaner BCA, Sievert C. Using High Frequency Chest Wall Oscillation in a Bronchiectasis Patient Population: An Outcomes-Based Case Review. Respiratory Therapy. 2016;10:01.
- Background: PubMed 32860696Allam NM, Badawy MM. Does High-Frequency Chest Wall Oscillation Have an Impact on Improving Pulmonary Function in Patients With Smoke Inhalation Injury? J Burn Care Res. 2021 Mar 4;42(2):300-304. doi: 10.1093/jbcr/iraa147.
- Background: PubMed 33144386Gonzalez-Bellido V, Velaz-Baza V, Blanco-Moncada E, Del Carmen Jimeno Esteo M, Cuenca-Zaldivar JN, Colombo-Marro A, Donadio MVF, Torres-Castro R. Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis. Respir Care. 2021 Mar;66(3):425-433. doi: 10.4187/respcare.08177. Epub 2020 Nov 3.
- Background: PubMed 33757568Shen MD, Guo LR, Li YW, Gao RT, Sui X, Du Z, Xu LQ, Shi HY, Ni YY, Zhang X, Pang Y, Zhang W, Yu TZ, Li F. Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial. Trials. 2021 Mar 23;22(1):228. doi: 10.1186/s13063-021-05184-x.
- 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.
Sidra Afzal, PP-DPT 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 High frequency chest wall oscillation and Active cycle of breathing 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 5 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 5 Jan 2023. 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?
BODE Index (time frame: 4th week). 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 NCT05424133, which also lists 7 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 5 Jan 2023.