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

NCT01682447 | Completed

• 1 other identifier: NL33713.008.10
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease COPD

Keywords

COPD; Cognitive Dysfunction; Pulmonary Rehabilitation; Quality of life; Cognitive rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Adherence to pulmonary rehabilitation

  These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.

• 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.

• Dropout from pulmonary rehabilitation

  From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.

Study Arms (2)

Extensive Pulmonary Rehabilitation (ERP)

EXPERIMENTAL

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

Waiting List Control group

NO INTERVENTION

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.

Interventions

Extensive Pulmonary Rehabilitation Program OTHER

Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Extensive Pulmonary Rehabilitation (ERP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD
• Referral to the Extensive Pulmonary Rehabilitation Program

You may not qualify if:

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

Sponsors & Collaborators

• Tilburg University: lead
• Revant Schoondonck Center for Pulmonary Rehabilitation Breda: collaborator
• Revant Innovation foundation: collaborator
• Fonds NutsOhra: collaborator

Study Sites (1)

Revant Schoondonck Center for Pulmonary Rehabilitation

Breda, 4817 JW, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Margriet M. Sitskoorn, PhD.

  Tilburg University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: September 11, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

NL (1)