NCT02249455

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

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

Timeline
Completed

Started Jul 2014

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 4, 2014

Last Update Submit

September 23, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in breathlessness cough sputum score

    change from baseline at 5 days

Study Arms (3)

Acapella

EXPERIMENTAL

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

Device: Acapella

ELTGOL

EXPERIMENTAL

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

Other: ELTGOL

conventional physiotherapy

ACTIVE COMPARATOR

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

Other: conventional physiotherapy

Interventions

AcapellaDEVICE

Treatment time for 20 min twice daily

Also known as: ACAPELLA DHD
Acapella
ELTGOLOTHER

ELTGOL technique 20 min twice daily

Also known as: Expiration in lateral position with open glottis for twenty min twice daily.
ELTGOL

Conventional physiotherapy was given twice daily for 20 min

conventional physiotherapy

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steffi Varghese

Coimbatore, Tamil Nadu, 641004, India

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exhalation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • steffi varghese, mpt

    psg ims&r

    PRINCIPAL INVESTIGATOR

Central Study Contacts

steffi varghese, mpt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduate in cardiopulmonary rehabiltation

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 25, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations