COPDNCT03319108

Comorbidity and Pulmonary Rehabilitation in COPD

A study testing Exercise in people with COPD, run by Izmir Katip Celebi University.

Completed

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

Trial summary

Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD
What is being tested?: Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 173 participants
Where: No sites listed yet
Study dates: Jan 2013to Feb 2017
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

About this study

Official title: The Effect of Severity of Co-morbidity on Outcomes of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

Read the detailed description

Chronic Obstructive Pulmonary Disease (COPD) is associated not only with respiratory system effects but also with systemic outcomes leading to numerous chronic comorbidities, and it is well known that patients benefit from pulmonary rehabilitation programs. However, the effect of presence of comorbidity on the outcome of pulmonary rehabilitation in patients with COPD is not clear. Therefore, our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes We included a total of 173 patients referred to the Izmir Suat Seren Chest Diseases and Surgery Training and Research Hospital Pulmonary Rehabilitation Unit. Comorbidities were recorded based on self reports. Charlson Comorbid Indexes (CCI) were calculated. Patients who defined at least one comorbidity were divided into two groups according to CCI; 1-3 as Group 1 and 4 and above as Group 2. Six minute walk test, mMRC dyspnea scale, SGRQ Respiratory Disease Questionnaire, respiratory function tests and arterial blood gases performed for assessment of patients before and after 16 sessions of pulmonary rehabilitation program.

Conditions: COPD
Being tested: Exercise
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

ExerciseOther
Pulmonary Rehabilitation Program for 8 weeks

Study groups in NCT03319108
Study group	Role	What they receive
Low Comorbidity Index Score	Other	CCI; 1-3 as Group 1 Receives: Other: Exercise
High Comorbidity Index Score	Other	CCI; 4 and above as Group 2 Receives: Other: Exercise

What is being measured

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

Exercise Capacity
Six minute walk test
Measured: 6 minute

Secondary outcomes (4)

Respiratory Functions
Pulmonary Function Tests
Measured: 30 minutes
Dyspnea
MMRC dyspnea scale
Measured: 5 minutes
Disease Specific Quality of Life
St George Respiratory Questionnaire
Measured: 20 minutes
Health Related Quality of Life
SF-36
Measured: 20 minutes

Timeline

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

Jan 2013Feb 2017

First posted24 Oct 2017
Study startJan 2013
Primary completionDec 2016
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03319108
Sponsor's protocol ID: IzmirKCU5
Status last verified: Oct 2017
First submitted: 19 Oct 2017
Last updated: 24 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Naz I, Sahin H, Varol Y, Komurcuoglu B. The effect of comorbidity severity on pulmonary rehabilitation outcomes in chronic obstructive pulmonary disease patients. Chron Respir Dis. 2019 Jan-Dec;16:1479972318809472. doi: 10.1177/1479972318809472.
PubMed 30428708

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?

Official record

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
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Severity of Co-morbidity on Outcomes of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
ClinicalTrials.gov ID: NCT03319108
Acronym / sponsor ID: IzmirKCU5
Conditions: COPD
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Izmir Katip Celebi UniversityUniversity, hospital or other
Study start: Jan 2013 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 24 Oct 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low Comorbidity Index Score	Other	Other: ExerciseCCI; 1-3 as Group 1
High Comorbidity Index Score	Other	Other: ExerciseCCI; 4 and above as Group 2

Who may qualify

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

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
ExercisePulmonary Rehabilitation Program for 8 weeks	Other	High Comorbidity Index Score, Low Comorbidity Index Score

Primary outcome

Exercise Capacity
Time frame: 6 minute
Six minute walk test

4 secondary outcomes

Respiratory Functions
Time frame: 30 minutes
Dyspnea
Time frame: 5 minutes
Disease Specific Quality of Life
Time frame: 20 minutes
Health Related Quality of Life
Time frame: 20 minutes

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 24 Oct 2017.
Derived from this study: PubMed 30428708Naz I, Sahin H, Varol Y, Komurcuoglu B. The effect of comorbidity severity on pulmonary rehabilitation outcomes in chronic obstructive pulmonary disease patients. Chron Respir Dis. 2019 Jan-Dec;16:1479972318809472. doi: 10.1177/1479972318809472.
Individual participant dataSharing planned: No

Related trials for 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
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with COPD, run by Izmir Katip Celebi University.

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

Who may be eligible to take part?

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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Exercise Capacity (time frame: 6 minute). 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 NCT03319108, which also lists 1 linked publication.

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 24 Oct 2017.