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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2013

Interventions

  • Other: Extensive Pulmonary Rehabilitation Program
    • Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 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 Measures

  • 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.
  • 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
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • COPD
  • Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Tilburg
  • Collaborator
    • Revant Schoondonck Center for Pulmonary Rehabilitation Breda
  • Provider of Information About this Clinical Study
    • Principal Investigator: Margriet M. Sitskoorn, Professor, PhD – University of Tilburg
  • Overall Official(s)
    • Margriet M. Sitskoorn, PhD., Principal Investigator, Tilburg University
    • Jan-Willem Meijer, MD., PhD., Study Chair, Revant Revalidatiecentrum Breda
    • Dirk Van Ranst, MD., Study Chair, Revant Revalidatiecentrum Breda
    • Carlijn A.M. Campman, MSc., Study Chair, Tilburg University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.