Clinical trial NCT05424133: ACBT and High Frequency Chest Wall Oscillations in COPD Patients
Official title: Comparative Effects of Active Cycle of Breathing Technique and High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chest wall oscillation
Respiration
Pulmonary disease
Chronic Obstructive
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: BODE Index
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Narowal
country: Pakistan
facility: DHQ Hospital Narowal
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Afzal, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barto 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.
citation: Ntritsos 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.
citation: Weycker 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.
citation: 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.
citation: Gonzalez-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.
citation: Shen 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.