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ACBT and High Frequency Chest Wall Oscillations in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High frequency chest wall oscillation
Active cycle of breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chest wall oscillation, Respiration, Pulmonary disease, Chronic Obstructive

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DHQ Hospital Narowal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active cycle of breathing technique

High frequency chest wall oscillation

Arm Description

Group A will receive Active cycle of breathing technique with routine chest physiotherapy.

Group B will receive High frequency chest wall oscillations with routine chest physiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
January 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05424133
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chest wall oscillation, Respiration, Pulmonary disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active cycle of breathing technique
Arm Type
Experimental
Arm Description
Group A will receive Active cycle of breathing technique with routine chest physiotherapy.
Arm Title
High frequency chest wall oscillation
Arm Type
Active Comparator
Arm Description
Group B will receive High frequency chest wall oscillations with routine chest physiotherapy
Intervention Type
Other
Intervention Name(s)
High frequency chest wall oscillation
Intervention Description
High frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Active cycle of breathing
Intervention Description
Active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes
Primary Outcome Measure Information:
Title
BODE Index
Description
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
Time Frame
4th week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ Hospital Narowal
City
Narowal
State/Province
Punjab
ZIP/Postal Code
51601
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32397703
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.
Results Reference
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PubMed Identifier
32538317
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.
Results Reference
background
PubMed Identifier
29785100
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
32860696
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.
Results Reference
background
PubMed Identifier
33144386
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.
Results Reference
background
PubMed Identifier
33757568
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.
Results Reference
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ACBT and High Frequency Chest Wall Oscillations in COPD Patients

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