Back to resultsPulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease COPD
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Extensive Pulmonary Rehabilitation Program
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease COPD focused on measuring COPD, Cognitive Dysfunction, Pulmonary Rehabilitation, Quality of life, Cognitive rehabilitation
Eligibility Criteria
Inclusion Criteria:
- COPD
- Referral to the Extensive Pulmonary Rehabilitation Program
Exclusion Criteria:
- Unfinished primary school
- Referral to the Compact Pulmonary Rehabilitation Program
Sites / Locations
- Revant Schoondonck Center for Pulmonary Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Extensive Pulmonary Rehabilitation (ERP)
Waiting List Control group
Arm Description
Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.
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.
Outcomes
Primary Outcome Measures
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
Change in Mood and Anxiety
Hospital Anxiety and Depression Scale (HADS)
Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
Change in Quality of Life
Saint George Respiratory Questionnaire (SGRQ)
SF-36 Health Survey
Change in 6 Minute Walking distance Test(6-MWT)
6 Minute Walking distance Test (6-MWT)
Change in Subjective Cognitive Functioning
Cognitive Failures Questionnaire (CFQ)
Secondary Outcome Measures
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.
Change in Fatigue
Chronic Respiratory Questionnaire (CRQ), subscale fatigue
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.
Full Information
NCT ID
NCT01682447
First Posted
July 16, 2012
Last Updated
October 27, 2017
Sponsor
Tilburg University
Collaborators
Revant Schoondonck Center for Pulmonary Rehabilitation Breda, Revant Innovation foundation, Fonds NutsOhra
1. Study Identification
Unique Protocol Identification Number
NCT01682447
Brief Title
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
Official Title
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tilburg University
Collaborators
Revant Schoondonck Center for Pulmonary Rehabilitation Breda, Revant Innovation foundation, Fonds NutsOhra
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease COPD
Keywords
COPD, Cognitive Dysfunction, Pulmonary Rehabilitation, Quality of life, Cognitive rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extensive Pulmonary Rehabilitation (ERP)
Arm Type
Experimental
Arm Description
Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.
Arm Title
Waiting List Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Extensive Pulmonary Rehabilitation Program
Intervention Description
Fulltime pulmonary rehabilitation program. Duration: 12 weeks
Primary Outcome Measure Information:
Title
Change in Objective Cognitive functioning
Description
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.
Title
Change in Mood and Anxiety
Description
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.
Title
Change in Quality of Life
Description
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.
Title
Change in 6 Minute Walking distance Test(6-MWT)
Description
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.
Title
Change in Subjective Cognitive Functioning
Description
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.
Secondary Outcome Measure Information:
Title
Adherence to pulmonary rehabilitation
Description
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.
Title
Change in Fatigue
Description
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.
Title
Dropout from pulmonary rehabilitation
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD
Referral to the Extensive Pulmonary Rehabilitation Program
Exclusion Criteria:
Unfinished primary school
Referral to the Compact Pulmonary Rehabilitation Program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margriet M. Sitskoorn, PhD.
Organizational Affiliation
Tilburg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan-Willem Meijer, MD., PhD.
Organizational Affiliation
Revant Revalidatiecentrum Breda
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dirk Van Ranst, MD.
Organizational Affiliation
Revant Revalidatiecentrum Breda
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlijn A.M. Campman, MSc.
Organizational Affiliation
Tilburg University
Official's Role
Study Chair
Facility Information:
Facility Name
Revant Schoondonck Center for Pulmonary Rehabilitation
City
Breda
ZIP/Postal Code
4817 JW
Country
Netherlands
12. IPD Sharing Statement
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Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
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