Pulmonary Rehabilitation in Interstitial Lung Diseases

NCT00882817 | Completed Phase 4

• 2 other identifiers: B32220095560S1490
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group. The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.

Conditions

Interstitial Lung Disease

Keywords

ILD

Outcome Measures

Primary Outcomes (1)

• changes in six minute walking distance after 6 months

  primary outcome of rehabilitation programm

  6 months

Secondary Outcomes (9)

• Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),

  3-6-12 months

• Change in peripheral and respiratory muscle force

  3-6-12 months

• Change in maximal exercise capacity

  3-6-12 months

• Change in daily physical activity measured by Sensewear armband

  3-6-12 months

• Changes in pulmonary function and blood gases at rest

  3-6-12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Pulmonary Rehabilitation

Other: Pulmonary Rehabilitation

2

NO INTERVENTION

Interventions

Pulmonary Rehabilitation OTHER

The intervention group will perform a 6 month pulmonary rehabilitation program which consists of training, patient education, nutrition counseling and psychosocial support. They will be evaluated with some tests for the study.

1

Eligibility Criteria

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

You may qualify if:

• Diagnosis of interstitial lung disease according to internationally established criteria
• Dyspnea on exertion
• Stable medical therapy

You may not qualify if:

• Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
• Life expectancy below 3 months

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, Flanders, 3000, Belgium

Location

Related Publications (1)

• Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.

  PMID: 30236104 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Silvia Pérez-Bogerd, MD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Wim Janssens, MD PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Wim Wuyts, MD PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

BE (1)