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

Chronic Obstructive Pulmonary Disease COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682447
• Other study ID #: NL33713.008.10
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: October 27, 2017
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2017
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD

• Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria:

• Unfinished primary school

• Referral to the Compact Pulmonary Rehabilitation Program

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Extensive Pulmonary Rehabilitation Program
Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Locations

Country	Name	City	State
Netherlands	Revant Schoondonck Center for Pulmonary Rehabilitation	Breda

Sponsors (4)

Lead Sponsor	Collaborator
University of Tilburg	Fonds NutsOhra, Revant Innovation foundation, Revant Schoondonck Center for Pulmonary Rehabilitation Breda

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.