CopdNCT04376892
Quality of Life and Exercise Capacity in COPD
An observational study of Copd and Quality of Life, run by Izmir Katip Celebi University.
Trial summary
COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Quality of Life, Exercise Capacity
- What is being tested?
- Quality of life measurement
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2020
- Phase
- Observational
- 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
Study population: COPD patients
Who may be able to join
- COPD patients completed all tests and qustionnaires
Who cannot join
- -
About this study
Official title: The Effect of Exercise Capacity on Quality of Life in COPD Patients
COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be determined as Group 4. The groups were compared in terms of quality of life, psychological symptoms and dyspnea.
Read the detailed description
Quality of life affects the mortality rate independently in patients with COPD. The treatment applied in COPD does not stop the decrease in lung function, nor does it prolong the survival time. Spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. Therefore, evaluating the quality of life has become an important measure of treatment in COPD patients. Quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. Identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments Our aim is to exercise capacity in COPD patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.
- Conditions
- Copd, Quality of Life, Exercise Capacity
- Being tested
- Quality of life measurement
- Keywords
- copd, quality of life, exercise capacity
- 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.
Quality of life measurementOther
Quality of life measurement by St. George Respiratory questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Exercise capacity under 149 meter Receives: Other: Quality of life measurement | |
| Group 2 | Exercise capacity between 150 and 249 meter Receives: Other: Quality of life measurement | |
| Group 3 | Exercise capacity between 250 and 349 meter Receives: Other: Quality of life measurement | |
| Group 4 | Exercise capacity above 340 Receives: Other: Quality of life measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire
St. George Respiratory Questionnaire
Measured: 20 minutes
Secondary outcomes (3)
Dyspnea Severity
mMRC
Measured: 5 minutes
Respiratory Function
Respiratory Function Test
Measured: 20 minutes
Anxiety Depression
Hospital anxiety and Depression Qustionnaire
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 posted6 May 2020
- Study startJan 2013
- Primary completionSep 2019
- Study completionMay 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 516 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
- NCT04376892
- Sponsor's protocol ID
- IKCU2
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hulya S, Ilknur N, Gulru P. Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease. Heart Lung. 2020 Nov-Dec;49(6):753-757. doi: 10.1016/j.hrtlng.2020.09.008. Epub 2020 Sep 23.
PubMed 32979640
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Capacity on Quality of Life in COPD Patients
- ClinicalTrials.gov ID
- NCT04376892
- Acronym / sponsor ID
- IKCU2
- Conditions
- Copd, Quality of Life, Exercise Capacity
- Keywords
- copd, quality of life, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 6 May 2020 (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.
COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be determined as Group 4. The groups were compared in terms of quality of life, psychological symptoms and dyspnea.
Detailed description
Quality of life affects the mortality rate independently in patients with COPD. The treatment applied in COPD does not stop the decrease in lung function, nor does it prolong the survival time. Spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. Therefore, evaluating the quality of life has become an important measure of treatment in COPD patients. Quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. Identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments Our aim is to exercise capacity in COPD patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Quality of life measurementExercise capacity under 149 meter |
| Group 2 | – | Other: Quality of life measurementExercise capacity between 150 and 249 meter |
| Group 3 | – | Other: Quality of life measurementExercise capacity between 250 and 349 meter |
| Group 4 | – | Other: Quality of life measurementExercise capacity above 340 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (1 listed)
- COPD patients completed all tests and qustionnaires
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 |
|---|---|---|
| Quality of life measurementQuality of life measurement by St. George Respiratory questionnaire | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Quality of life questionnaire
Time frame: 20 minutes
St. George Respiratory Questionnaire
3 secondary outcomes
Dyspnea Severity
Time frame: 5 minutes
Respiratory Function
Time frame: 20 minutes
Anxiety 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 6 May 2020.
- Derived from this study: PubMed 32979640Hulya S, Ilknur N, Gulru P. Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease. Heart Lung. 2020 Nov-Dec;49(6):753-757. doi: 10.1016/j.hrtlng.2020.09.008. Epub 2020 Sep 23.
- Individual participant dataSharing planned: No
Related trials for Copd
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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?
An observational study of Copd and Quality of Life, 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 1 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 6 May 2020. 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?
Quality of life questionnaire (time frame: 20 minutes). 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 NCT04376892, 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 6 May 2020.