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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease COPD
• Interventions: Other: Extensive Pulmonary Rehabilitation Program

• Registration Number: NCT01682447
• Lead Sponsor: Tilburg University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• COPD
• Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria

• Unfinished primary school
• Referral to the Compact Pulmonary Rehabilitation Program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extensive Pulmonary Rehabilitation (ERP)	Extensive Pulmonary Rehabilitation Program	Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.

Primary Outcome Measures

Name	Time	Method
Change in Mood and Anxiety	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.	Hospital Anxiety and Depression Scale (HADS); Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
Change in Quality of Life	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.	Saint George Respiratory Questionnaire (SGRQ); SF-36 Health Survey
Change in 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.	6 Minute Walking distance Test (6-MWT)
Change in Objective Cognitive functioning	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.	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 Subjective Cognitive Functioning	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.	Cognitive Failures Questionnaire (CFQ)

Secondary Outcome Measures

Name	Time	Method
Dropout from pulmonary rehabilitation	From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.	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.
Adherence to pulmonary rehabilitation	These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.	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	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.	Chronic Respiratory Questionnaire (CRQ), subscale fatigue

Trial Locations

Locations (1)

Revant Schoondonck Center for Pulmonary Rehabilitation; 🇳🇱 Breda, Netherlands