Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema

• Sponsor: Villa Pineta Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01305668
• Collaborator: (none)
• Enrollment: 100
• Locations: 5
• Duration (Months): 16
• Patients Per Site: 20
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.

The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.

The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease; Emphysema

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Emphysema phenotype
No-Emphysema phenotype

Outcome Measures

Primary Outcome Measures

1. Exercise tolerance [[Time Frame: Day 1 and 20 ]]

   Change in Six minute walked distance (6MWD)

Secondary Outcome Measures

1. Dyspnoea [[ Time Frame: Day 1 and 20]]

   Change in dyspnea grade by MRC

2. Symptoms on effort [[ Time Frame: Day 1 and 20]]

   Change in Dyspnoea and leg fatigue by Borg scale

3. Perceived Quality of life [[ Time Frame: Day 1 and 20]]

   Change in Saint George Respiratory Questionnarie (Italian version)

4. Global function [[ Time Frame: Day 1 and 20]]

   Change in the multidimensional BODE index (validated in COPD population)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• COPD disease with any functional grade

• Adherence to participate to a pulmonary rehabilitation program

Exclusion Criteria:

• Recent acute exacerbation (4 weeks preceding enrollment)

• Acute severe concomitant cardiovascular diseases

• Concomitant neoplastic diseases

• NO-Adherence to participate to a pulmonary rehabilitation program

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Maugeri IRCCS	Lumezzane	Brescia	Italy
2	Villa Pineta Hospital	Pavullo	Modena	Italy	41026
3	Auxilium Vitae Rehabilitation Center	Volterra	Pisa	Italy
4	Ospedale San Raffaele	Velletri	Roma	Italy
5	Clinic Center	Naples		Italy

Sponsors and Collaborators

• Villa Pineta Hospital

Investigators

• Study Director: Enrico M Clini, MD, Villa Pineta Hospital and University of Modena and Reggio Emilia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Clini Enrico, Villa Pineta Hospital, Villa Pineta Hospital
• ClinicalTrials.gov Identifier: NCT01305668
• Other Study ID Numbers: VP-01-2011
• First Posted: Mar 1, 2011
• Last Update Posted: Dec 10, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Prof. Clini Enrico, Villa Pineta Hospital, Villa Pineta Hospital: COPD; Emphysema phenotype
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema

Study Results

No Results Posted as of Dec 10, 2014