A Trial to Study the Effects of Pulmonary Rehabilitation Program on Exercise Capacity and Quality of Life in Patients With Severe Form of Chronic Obstructive Pulmonary Disease (COPD)

NCT02512549 | Completed DMC

• 1 other identifier: AIIMS-DM Thesis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized parallel group controlled trial which aims to study the effects of pulmonary rehabilitation intervention on exercise capacity and quality of life in patients with severe COPD as compared to standard medical care. The expected duration is one and a half years with effect from 1st July, 2015 and will include 80 patients, 40 in each arm.

Conditions

Pulmonary Disease, Chronic Obstructive; Rehabilitation

Keywords

Chronic Obstructive Pulmonary Disease; rehabiltation

Outcome Measures

Primary Outcomes (2)

• To assess the change in health related quality of life in experimental arm (Saint George Respiratory Questionnaire)

  Quality of life will be assessed by Saint George Respiratory Questionnaire

  2 months

• To assess the change in Six Minute Walk Distance in experimental arm

  Exercise Capacity as measured by six minutes walk distance

  2 months

Secondary Outcomes (4)

• BODE index

  2 months

• Lung Functions

  2 months

• Anxiety and Depression scale

  2 months

• Maximum exercise capacity

  2 months

Study Arms (2)

Rehabilitation

ACTIVE COMPARATOR

Patients with diagnosed Chronic Obstructive Pulmonary Disease with severe airflow obstruction (spirometric forced expiratory volume in one second (FEV1) below 50% of the normal) and modified medical research council (mMRC) dyspnea grading 1 to 3 will undergo pulmonary rehabilitation program thrice a week for 2 months.

Other: Pulmonary Rehabilitation

Usual Care

NO INTERVENTION

Patients with COPD as described in rehabilitation arm, will be provided usual care from the hospital outpatient clinic.

Interventions

Pulmonary Rehabilitation OTHER

Rehabilitation

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate to severe COPD based on spirometry (FEV1: \<50%) presenting to pulmonary medicine outpatient clinic with mMRC grade 1 to 3.
• Those who are willing to participate in the study

You may not qualify if:

• Patients on long term oxygen therapy or candidates for long term oxygen therapy
• Patients with severe orthopedic or neurological disorders limiting their mobility
• Exercise induced syncope
• Unstable angina or recent MI (within 4 months)
• Diagnosed Cognitive or active psychiatric disorders
• Co morbidities: uncontrolled hypertension \>180/100
• Recent hospitalization for exacerbation within 6 weeks

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Science and Technology

Delhi, National Capital Territory of Delhi, 119061, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Anant Mohan, MD

  All India Institute of Medical Sciences

  STUDY DIRECTOR

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: DM Senior Resident, Department of Pulmonary Medicine and Sleep Disorders

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 31, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

IN (1)