CopdNCT04009538
Re-Rehabilitation in Chronic Obstrctive Pulmonary Disease
A study testing Rehabilitation program in people with Copd and Smoking, run by Izmir Katip Celebi University.
Trial summary
Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Smoking, Smoking Cessation
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2019
- 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
- Above 18 years
- Completed PR program
Who cannot join
- -
About this study
Official title: The Effect of Re-Rehabilitation in Patients With COPD
Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.
Read the detailed description
Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.
Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.
- Conditions
- Copd, Smoking, Smoking Cessation, Rehabilitation; Tobacco Use
- Being tested
- Rehabilitation program
- Keywords
- copd, smoking, Smoking Cessation, Rehabilitation; Tobacco Use
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
Also called exercise
exercise program twice a week
| Study group | Role | What they receive |
|---|---|---|
| COPD patients participated PR program | Experimental | COPD patients participated first and second PR program Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Six minutes walk test
Measured: 6 minutes
Secondary outcomes (4)
Respiratory Functions
Pulmonary Function Test
Measured: 30 minutes
Dyspnea Sensation
We used "Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. The score "1" represents the best level, where the score "5" indicates the poorest.
Measured: 5 minutes
Disease Specific Quality of Life
We used St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms.
Measured: 20 minutes
Anxiety and Depression
Hospital Anxiety and Depression (HAD) Inventory was used for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJan 2013
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- COPD patient participated first and second rehabilitation program
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009538
- Sponsor's protocol ID
- IzmirKCU1
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Re-Rehabilitation in Patients With COPD
- ClinicalTrials.gov ID
- NCT04009538
- Acronym / sponsor ID
- IzmirKCU1
- Conditions
- Copd, Smoking, Smoking Cessation, Rehabilitation; Tobacco Use
- Keywords
- copd, smoking, Smoking Cessation, Rehabilitation; Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 5 Jul 2019 (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.
Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.
Detailed description
Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.
Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- COPD patient participated first and second rehabilitation program
| Arm | Type | Receives |
|---|---|---|
| COPD patients participated PR program | Experimental | Other: Rehabilitation programCOPD patients participated first and second PR program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years
- Completed PR program
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Rehabilitation programAlso: exerciseexercise program twice a week | Other | COPD patients participated PR program |
Primary outcome
Exercise Capacity
Time frame: 6 minutes
Six minutes walk test
4 secondary outcomes
Respiratory Functions
Time frame: 30 minutes
Dyspnea Sensation
Time frame: 5 minutes
Disease Specific Quality of Life
Time frame: 20 minutes
Anxiety and Depression
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 5 Jul 2019.
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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.
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 Rehabilitation program in people with Copd and Smoking, 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?
The sponsor lists 2 inclusion and 1 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 5 Jul 2019. 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 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.