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

October 27, 2017 updated by: Margriet M. Sitskoorn, Tilburg University

Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Breda, Netherlands, 4817 JW
        • Revant Schoondonck Center for Pulmonary Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD
  • Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria:

  • Unfinished primary school
  • Referral to the Compact Pulmonary Rehabilitation Program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Extensive Pulmonary Rehabilitation Program
Fulltime pulmonary rehabilitation program. Duration: 12 weeks
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Objective Cognitive functioning
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
CNS-Vital Signs, computerized neuropsychological assessment WMS - Verbal Paired Associates Direct Recall Word fluency-category (GIT): animals & profession Letter fluency: D-A-T Purdue Pegboard
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Change in Mood and Anxiety
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.

Hospital Anxiety and Depression Scale (HADS)

Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Change in Quality of Life
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.

Saint George Respiratory Questionnaire (SGRQ)

SF-36 Health Survey
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Change in 6 Minute Walking distance Test(6-MWT)
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
6 Minute Walking distance Test (6-MWT)
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Change in Subjective Cognitive Functioning
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Cognitive Failures Questionnaire (CFQ)
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to pulmonary rehabilitation
Time Frame: These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.

Percentage of attendance of treatment session is collected from patients medical records.

Adherence to pulmonary rehabilitation is specified as the percentage of the prescribed treatment sessions that patients actually attend. Adherence is further specified in the following categories: disease, motivation, other.

We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of adherence to pulmonary rehabilitation.
These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.
Change in Fatigue
Time Frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Chronic Respiratory Questionnaire (CRQ), subscale fatigue
In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
Dropout from pulmonary rehabilitation
Time Frame: From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.

Dropout can be specified as the percentage of patients who, though eligible, do not start pulmonary rehabilitation or patients who do not finish pulmonary rehabilitation. Dropout is further specified in the following categories: death, disease, motivation, practical (e.g. move).

We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of dropout from pulmonary rehabilitation.
From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tilburg University

Collaborators

Fonds NutsOhra
Revant Schoondonck Center for Pulmonary Rehabilitation Breda
Revant Innovation foundation

Investigators

  • Principal Investigator: Margriet M. Sitskoorn, PhD., Tilburg University
  • Study Chair: Jan-Willem Meijer, MD., PhD., Revant Revalidatiecentrum Breda
  • Study Chair: Dirk Van Ranst, MD., Revant Revalidatiecentrum Breda
  • Study Chair: Carlijn A.M. Campman, MSc., Tilburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL33713.008.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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