Trial record 2 of 281 for:
pulmonary rehabilitation
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
This study is currently recruiting participants.
Verified September 2012 by University of Tilburg
Sponsor:
University of Tilburg
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: September 6, 2012
Last verified: September 2012
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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: | February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682447
Contacts
| Contact: Carlijn A.M. Campman, MSc. | +31-13-4663197 | c.a.m.campman@uvt.nl |
Locations
| Netherlands | |
| Revant Schoondonck Center for Pulmonary Rehabilitation | Recruiting |
| Breda, Netherlands, 4817 JW | |
| Contact: Carlijn A.M. Campman, MSc. +31-13-366-3197 c.a.m.campman@uvt.nl | |
| Principal Investigator: Jan-Willem Meijer, PhD | |
| Principal Investigator: Dirk Van Ranst | |
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: | September 6, 2012 |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013