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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02249455
Other study ID # 14\305
Secondary ID
Status Recruiting
Phase N/A
First received September 4, 2014
Last updated September 23, 2014
Start date July 2014
Est. completion date January 2015

Study information

Verified date September 2014
Source PSG College of Physiotherapy
Contact steffi varghese, mpt
Phone 9677465724
Email steffivarghesep@gmail.com
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Acapella
Treatment time for 20 min twice daily
Other:
ELTGOL
ELTGOL technique 20 min twice daily
conventional physiotherapy
Conventional physiotherapy was given twice daily for 20 min

Locations

Country Name City State
India Steffi Varghese Coimbatore Tamilnadu

Sponsors (1)

Lead Sponsor Collaborator
PSG College of Physiotherapy

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Force expiratory volume in one second Fev1/fvc values were noted after pre and post intervention of airway clearance manoeuver change from baseline at 30 minutes No
Secondary Change in breathlessness cough sputum score Bcss scale was interviewed to the patient on first day and the fifth day. The changes were noted. change from baseline at 5 days No
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