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

NCT02883101 | Completed

• 1 other identifier: IESC/T-345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-cystic Fibrosis Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Assessed using 6 minute walk distance and cardiopulmonary exercise testing

  8 weeks

Secondary Outcomes (4)

• Cough related QoL

  8 weeks

• Health Related Quality of Life

  8 weeks

• Lung Functions

  8 weeks

• Anxiety and depressions score

  8 weeks

Study Arms (2)

Pulmonary rehabilitation group

ACTIVE COMPARATOR

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

Standard care group

NO INTERVENTION

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.

Interventions

Pulmonary Rehabilitation BEHAVIORAL

The Rehabilitation Programme will include the following : i. Patient education ii. Exercise training iii. Ventilator and breathing exercises

Also known as: The Rehabilitation Programme

Pulmonary rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Dr. Rohit Kumar

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 30, 2016
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 5, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)