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Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Acapella
ELTGOL
conventional physiotherapy
Sponsored by
PSG College of Physiotherapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild copd
  • Moderate copd
  • Patient able to sustain expiratory flow greater than 15l/min
  • Patient expectorate more than 25.-30ml

Exclusion Criteria:

  • Severe copd
  • Peripheral oxygen saturation lower than 85%
  • Rr>35breaths/min
  • Current acute chest pain
  • Recent history of haemoptysis

Sites / Locations

  • Steffi VargheseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Acapella

ELTGOL

conventional physiotherapy

Arm Description

Acapella is given to the patients twice daily for 20 min.

Expiration with open glottis in lateral position is done twice daily for 20 min

Conventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min.

Outcomes

Primary Outcome Measures

Change in Force expiratory volume in one second
Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver

Secondary Outcome Measures

Change in breathlessness cough sputum score
Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted.

Full Information

First Posted
September 4, 2014
Last Updated
September 23, 2014
Sponsor
PSG College of Physiotherapy
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1. Study Identification

Unique Protocol Identification Number
NCT02249455
Brief Title
Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study
Official Title
Effectiveness of Acapella and ELTGOL (Expiration in Lateral Position With Open Glottis)Technique to Promote Airway Clearance in COPD Patients:a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
PSG College of Physiotherapy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of acapella and expiration against open glottis (ELTGOL) technique in promoting airway clearance of chronic obstructive pulmonary disease (COPD) patients
Detailed Description
This study is carried out to determine the effectiveness of acapella and expiration in lateral position with open glottis to clear the secretion in COPD patients. The sessions will be carried twice daily for twenty minutes. The outcome measures are values of pre and post intervention fev1/fvc and breathlessness cough sputum scale. Duration of the study will be for five days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acapella
Arm Type
Experimental
Arm Description
Acapella is given to the patients twice daily for 20 min.
Arm Title
ELTGOL
Arm Type
Experimental
Arm Description
Expiration with open glottis in lateral position is done twice daily for 20 min
Arm Title
conventional physiotherapy
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy like breathing exercise, active coughing, chest mobilisation was encouraged twice daily for 20 min.
Intervention Type
Device
Intervention Name(s)
Acapella
Other Intervention Name(s)
ACAPELLA DHD
Intervention Description
Treatment time for 20 min twice daily
Intervention Type
Other
Intervention Name(s)
ELTGOL
Other Intervention Name(s)
Expiration in lateral position with open glottis for twenty min twice daily.
Intervention Description
ELTGOL technique 20 min twice daily
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
Conventional physiotherapy was given twice daily for 20 min
Primary Outcome Measure Information:
Title
Change in Force expiratory volume in one second
Description
Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver
Time Frame
change from baseline at 30 minutes
Secondary Outcome Measure Information:
Title
Change in breathlessness cough sputum score
Description
Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted.
Time Frame
change from baseline at 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild copd Moderate copd Patient able to sustain expiratory flow greater than 15l/min Patient expectorate more than 25.-30ml Exclusion Criteria: Severe copd Peripheral oxygen saturation lower than 85% Rr>35breaths/min Current acute chest pain Recent history of haemoptysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
steffi varghese, mpt
Phone
9677465724
Email
steffivarghesep@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
steffi varghese, mpt
Organizational Affiliation
psg ims&r
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steffi Varghese
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mahesh, mpt
Phone
04222570170
First Name & Middle Initial & Last Name & Degree
shanmugapriya, mpt
Phone
04222570170

12. IPD Sharing Statement

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Effectiveness of Acapella and ELTGOL Technique to Promote Airway Clearance in COPD:a Comparative Study

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