Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD

NCT ID: NCT01682447

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this project is to investigate whether a 12-week, fulltime pulmonary rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease COPD

Keywords

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COPD Cognitive Dysfunction Pulmonary Rehabilitation Quality of life Cognitive rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Extensive Pulmonary Rehabilitation (ERP)

Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.

Group Type EXPERIMENTAL

Extensive Pulmonary Rehabilitation Program

Intervention Type OTHER

Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Waiting List Control group

Participants in the waiting list control group are measured on primary and secondary outcome measures before and after waiting time for the extensive pulmonary rehabilitation program and start with this program after the second moment of measurement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extensive Pulmonary Rehabilitation Program

Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* COPD
* Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria

* Unfinished primary school
* Referral to the Compact Pulmonary Rehabilitation Program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revant Schoondonck Center for Pulmonary Rehabilitation Breda

UNKNOWN

Sponsor Role collaborator

Revant Innovation foundation

UNKNOWN

Sponsor Role collaborator

Fonds NutsOhra

OTHER

Sponsor Role collaborator

Tilburg University

OTHER

Sponsor Role lead

Responsible Party

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Margriet M. Sitskoorn

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margriet M. Sitskoorn, PhD.

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

Jan-Willem Meijer, MD., PhD.

Role: STUDY_CHAIR

Revant Revalidatiecentrum Breda

Dirk Van Ranst, MD.

Role: STUDY_CHAIR

Revant Revalidatiecentrum Breda

Carlijn A.M. Campman, MSc.

Role: STUDY_CHAIR

Tilburg University

Locations

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Revant Schoondonck Center for Pulmonary Rehabilitation

Breda, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL33713.008.10

Identifier Type: -

Identifier Source: org_study_id