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The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883101
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Rohit Kumar, All India Institute of Medical Sciences, New Delhi

Brief Summary:

Number of Patients:

Study group - Bronchiectasis that is not attributable to Cystic fibrosis

  • Group 1 - Pulmonary Rehabilitation
  • Group 2 - Standard care

Sample size - 20 in each arm

Study Design:

  • Randomised controlled trial (RCT)

All patients who qualify for the study will undergo a detailed evaluation. Baseline assessment will include the following parameters:

  • Anthropometry
  • Pulmonary Function Tests and Respiratory muscle strength
  • Cardiopulmonary Exercise Testing (CPET)
  • Six Minute Walk Test (6MWT)
  • Severity of dyspnoea (Dyspnoea scale)
  • Limb muscle strength
  • Inflammatory markers in the serum - C-reactive protein
  • Quality of Life

Patients will then be randomized (using table of random numbers) to either the pulmonary rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation, patients will again be reassessed by the aforementioned tools.


Condition or disease Intervention/treatment Phase
Non-cystic Fibrosis Bronchiectasis Behavioral: Pulmonary Rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis: A Randomised Controlled Trial
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pulmonary rehabilitation group

Participants randomised to the PR group will receive exercise training and regular instruction in self-management of ACT along with standard care. Patients will be enrolled into the pulmonary rehabilitation programme, in the Department of Pulmonary Medicine and Sleep disorders, All India Institute of Medical Sciences.

The total duration of the programme would be 8 weeks, with thrice weekly sessions of exercise training of 1 hour duration each. Of these sessions, at least 2 will be supervised while one will be at home. The patient will be asked to maintain a personal log recording the date, time, duration and type of exercise performed to ensure compliance, and these will be regularly reviewed and monitored.

The Rehabilitation Programme will include the following:

i. Patient education ii. Exercise training iii. Ventilator and breathing exercises

Behavioral: Pulmonary Rehabilitation

The Rehabilitation Programme will include the following :

i. Patient education ii. Exercise training iii. Ventilator and breathing exercises

Other Name: The Rehabilitation Programme

No Intervention: Standard care group
Candidates randomized to the "standard care group" will receive standard care for bronchiectasis according to current guidelines. These participants will receive instruction and review of airway clearance therapy (ACT). Each participant will be provided with written information about bronchiectasis and education regarding self-management of the condition. Participants who have not been previously instructed in any ACT will be taught the active cycle of breathing technique. These participants will not receive any supervised exercise training.



Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: 8 weeks ]
    Assessed using 6 minute walk distance and cardiopulmonary exercise testing


Secondary Outcome Measures :
  1. Cough related QoL [ Time Frame: 8 weeks ]
    Assessed using Leicester Cough Questionnaire

  2. Health Related Quality of Life [ Time Frame: 8 weeks ]
    Assessed using St George Respiratory questionnaire

  3. Lung Functions [ Time Frame: 8 weeks ]
    Assessed using pulmonary function testing

  4. Anxiety and depressions score [ Time Frame: 8 weeks ]
    Assessed using Depression Anxiety and Stress Scale (DASS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed bronchiectasis that is not attributable to cystic fibrosis, confirmed radiologically on high resolution computed tomography
  • Exertional dyspnoea (Modified Medical Research Council (mMRC) score ≥ 2 and a history of at least two exacerbations in the past year
  • Willing to give informed consent

Exclusion Criteria:

  • Smoking history ≥ 10 pack years or physician diagnosis of chronic obstructive pulmonary disease
  • A clinical diagnosis of asthma
  • Interstitial lung disease (clinical/radiological diagnosis)
  • Medical conditions which could place the individual at risk during exercise testing or training (eg. angina) or conditions that may restrict the participant's ability to exercise (eg. severe orthopaedic or neurologic impairments);
  • Participation in a PR program within the last 12 months.
  • Patient having an exacerbation of bronchiectasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883101


Locations
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India
Dr. Rohit Kumar
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi

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Responsible Party: Dr. Rohit Kumar, Senior Resident, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02883101     History of Changes
Other Study ID Numbers: IESC/T-345
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases