Clinical trial NCT01682447: Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
Official title: Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: COPD
Cognitive Dysfunction
Pulmonary Rehabilitation
Quality of life
Cognitive rehabilitation
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Revant Schoondonck Center for Pulmonary Rehabilitation Breda
name: Revant Innovation foundation
name: Fonds NutsOhra
First posted: 2012-09-11
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: Inclusion Criteria:

* COPD
* Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Objective Cognitive functioning
timeFrame: 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.
measure: Change in Mood and Anxiety
timeFrame: 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.
measure: Change in Quality of Life
timeFrame: 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.
measure: Change in 6 Minute Walking distance Test(6-MWT)
timeFrame: 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.
measure: Change in Subjective Cognitive Functioning
timeFrame: 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
timeFrame: These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.
measure: Change in Fatigue
timeFrame: 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.
measure: Dropout from pulmonary rehabilitation
timeFrame: From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Revant Schoondonck Center for Pulmonary Rehabilitation
Study officials:
affiliation: Tilburg University
name: Margriet M. Sitskoorn, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Revant Revalidatiecentrum Breda
name: Jan-Willem Meijer, MD., PhD.
role: STUDY_CHAIR
affiliation: Revant Revalidatiecentrum Breda
name: Dirk Van Ranst, MD.
role: STUDY_CHAIR
affiliation: Tilburg University
name: Carlijn A.M. Campman, MSc.
role: STUDY_CHAIR
References: