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Completed

NCT Number: NCT01682447

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD Chronic Disease Cognition Disorders Cognitive Dysfunction Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Revant Schoondonck Center for Pulmonary Rehabilitation

Breda, 4817 JW, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD
  • Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion criteria

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

Treatment and study plan

Extensive Pulmonary Rehabilitation Program

Other

Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Tilburg University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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