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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Revant Schoondonck Center for Pulmonary Rehabilitation Breda
Revant Innovation foundation
NutsOhra Foundation
Information provided by (Responsible Party):
Margriet M. Sitskoorn, University of Tilburg
ClinicalTrials.gov Identifier:
NCT01682447
First received: July 16, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease COPD
Other: Extensive Pulmonary Rehabilitation Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Primary Outcome 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Cognitive Failures Questionnaire (CFQ)


Secondary Outcome 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 128
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD
  • Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria:

  • Unfinished primary school
  • Referral to the Compact Pulmonary Rehabilitation Program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682447

Locations
Netherlands
Revant Schoondonck Center for Pulmonary Rehabilitation
Breda, Netherlands, 4817 JW
Sponsors and Collaborators
University of Tilburg
Revant Schoondonck Center for Pulmonary Rehabilitation Breda
Revant Innovation foundation
NutsOhra 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
  More Information

No publications provided

Responsible Party: Margriet M. Sitskoorn, Professor, PhD, University of Tilburg
ClinicalTrials.gov Identifier: NCT01682447     History of Changes
Other Study ID Numbers: NL33713.008.10
Study First Received: July 16, 2012
Last Updated: June 27, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University of Tilburg:
COPD
Cognitive Dysfunction
Pulmonary Rehabilitation
Quality of life
Cognitive rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014