NCT05424133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

Chest wall oscillationRespirationPulmonary diseaseChronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • 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

    4th week

Study Arms (2)

Active cycle of breathing technique

EXPERIMENTAL

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

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

Other: High frequency chest wall oscillation

Interventions

High frequency chest wall oscillations at 13-15Hz oscillating frequency for 20 minutes twice a day for 4 weeks.

High frequency chest wall oscillation

Active cycle of breathing technique and it will performed twice a day for 4 week intervention period for 20 minutes

Active cycle of breathing technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital Narowal

Narowal, Punjab Province, 51601, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 32397703BACKGROUND
  • 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.

    PMID: 32538317BACKGROUND
  • 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.

    PMID: 29785100BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32860696BACKGROUND
  • 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.

    PMID: 33144386BACKGROUND
  • 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.

    PMID: 33757568BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory AspirationLung Diseases

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 21, 2022

Study Start

March 15, 2022

Primary Completion

October 15, 2022

Study Completion

October 31, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations