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

Study Overview
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Brief Summary
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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).

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

Conditions
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Chronic Obstructive Pulmonary Disease COPD

Intervention / Treatment
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* Other: Extensive Pulmonary Rehabilitation Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD Referral to the Extensive Pulmonary Rehabilitation Program Exclusion Criteria: Unfinished primary school Referral to the Compact Pulmonary Rehabilitation Program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensive Pulmonary Rehabilitation (ERP)<br>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<br>* Fulltime pulmonary rehabilitation program. Duration: 12 weeks<br>|
| No Intervention: Waiting List Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Objective Cognitive functioning | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Cognitive Dysfunction, Pulmonary Rehabilitation, Quality of life, Cognitive rehabilitation