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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
261
Fulltime pulmonary rehabilitation program. Duration: 12 weeks
Revant Schoondonck Center for Pulmonary Rehabilitation
Breda, Netherlands
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
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.
Change in Mood and Anxiety
Hospital Anxiety and Depression Scale (HADS) Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
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.
Change in Quality of Life
Saint George Respiratory Questionnaire (SGRQ) SF-36 Health Survey
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.
Change in 6 Minute Walking distance Test(6-MWT)
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.
Change in Subjective Cognitive Functioning
Cognitive Failures Questionnaire (CFQ)
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.
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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.
Time frame: 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
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.
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.
Time frame: From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.