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Clinical Trials/NCT01682447
NCT01682447
Completed
Not Applicable

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

Tilburg University1 site in 1 country261 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease COPD
Sponsor
Tilburg University
Enrollment
261
Locations
1
Primary Endpoint
Change in Mood and Anxiety
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
June 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tilburg University
Responsible Party
Principal Investigator
Principal Investigator

Margriet M. Sitskoorn

Professor, PhD

Tilburg University

Eligibility Criteria

Inclusion Criteria

  • Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

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

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)

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

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)

Secondary Outcomes

  • Dropout from pulmonary rehabilitation(From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.)
  • 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(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.)

Study Sites (1)

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