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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01682447
Enrollment
261
Registered
2012-09-11
Start date
2011-01-31
Completion date
2014-06-30
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease COPD

Keywords

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

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).

Interventions

OTHERExtensive Pulmonary Rehabilitation Program

Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Sponsors

Revant Schoondonck Center for Pulmonary Rehabilitation Breda
CollaboratorUNKNOWN
Revant Innovation foundation
CollaboratorUNKNOWN
Fonds NutsOhra
CollaboratorOTHER
Tilburg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* COPD * Referral to the Extensive Pulmonary Rehabilitation Program

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Subjective Cognitive FunctioningIn 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)
Change in Mood and AnxietyIn 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 LifeIn 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 functioningIn 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

Secondary

MeasureTime frameDescription
Change in FatigueIn 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
Dropout from pulmonary rehabilitationFrom 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 rehabilitationThese 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026