Chronic Obstructive Pulmonary Disease COPDNCT01682447

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

A study testing Extensive Pulmonary Rehabilitation Program in people with Chronic Obstructive Pulmonary Disease COPD, run by Tilburg University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease COPD
What is being tested?: Extensive Pulmonary Rehabilitation Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 261 participants
Where: 1 siteNetherlands
Study dates: Jan 2011to Jun 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

COPD
Referral to the Extensive Pulmonary Rehabilitation Program

Who cannot join

Unfinished primary school
Referral to the Compact Pulmonary Rehabilitation Program

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Revant Schoondonck Center for Pulmonary Rehabilitation
Breda, 4817 JW

Other trials in Netherlands

About this study

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

Conditions: Chronic Obstructive Pulmonary Disease COPD
Being tested: Extensive Pulmonary Rehabilitation Program
Keywords: COPD, Cognitive Dysfunction, Pulmonary Rehabilitation, Quality of life, Cognitive rehabilitation
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extensive Pulmonary Rehabilitation ProgramOther
Fulltime pulmonary rehabilitation program. Duration: 12 weeks

Study groups in NCT01682447
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jun 2014

First posted11 Sep 2012 (estimated)
Study startJan 2011
Primary completionDec 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary Disease COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682447
Sponsor's protocol ID: NL33713.008.10
Status last verified: Oct 2017
First submitted: 16 Jul 2012
Last updated: 31 Oct 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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All Chronic Obstructive Pulmonary Disease COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01682447
Acronym / sponsor ID: NL33713.008.10
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: COPD, Cognitive Dysfunction, Pulmonary Rehabilitation, Quality of life, Cognitive rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Tilburg UniversityUniversity, hospital or other
Collaborators: Revant Schoondonck Center for Pulmonary Rehabilitation Breda, Revant Innovation foundation, Fonds NutsOhra
Study start: Jan 2011
Primary completion: Dec 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Extensive Pulmonary Rehabilitation (ERP)	Experimental	Other: Extensive Pulmonary Rehabilitation ProgramParticipants in this group are measured on primary and secondary outcome measures before and after a 12 week 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

COPD
Referral to the Extensive Pulmonary Rehabilitation Program

Key exclusion criteria (2 listed)

Unfinished primary school
Referral to the Compact Pulmonary Rehabilitation Program

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extensive Pulmonary Rehabilitation ProgramFulltime pulmonary rehabilitation program. Duration: 12 weeks	Other	Extensive Pulmonary Rehabilitation (ERP)

Primary outcome

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.
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 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.
Hospital Anxiety and Depression Scale (HADS) Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
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.
Saint George Respiratory Questionnaire (SGRQ) SF-36 Health Survey
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.
6 Minute Walking distance Test (6-MWT)
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.
Cognitive Failures Questionnaire (CFQ)

3 secondary outcomes

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.

Related trials for Chronic Obstructive Pulmonary Disease COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margriet M. Sitskoorn, PhD. principal investigator

Tilburg University

Jan-Willem Meijer, MD., PhD. study chair

Revant Revalidatiecentrum Breda

Dirk Van Ranst, MD. study chair

Revant Revalidatiecentrum Breda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Extensive Pulmonary Rehabilitation Program in people with Chronic Obstructive Pulmonary Disease COPD, run by Tilburg University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01682447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.