Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease copd
Treatment extensive pulmonary rehabilitation program
Sponsor University of Tilburg
Collaborator Revant Schoondonck Center for Pulmonary Rehabilitation Breda
Start date January 2011
End date December 2014
Trial size 128 participants
Trial identifier NCT01682447, NL33713.008.10

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.
extensive pulmonary rehabilitation program
Fulltime pulmonary rehabilitation program. Duration: 12 weeks
(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.

Primary Outcomes

Measure
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.
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.
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.
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.
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.

Secondary Outcomes

Measure
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.
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.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - COPD - Referral to the Extensive Pulmonary Rehabilitation Program Exclusion Criteria: - Unfinished primary school - Referral to the Compact Pulmonary Rehabilitation Program

Additional Information

Official title Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Principal investigator Margriet M. Sitskoorn, PhD.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Tilburg.