Pain, ChronicNCT04048408
Comparison of Respiratory Muscle, Pain, Functional Performance and Cognitive Status in Obstructive Lung Diseases
An observational study of Pain, Chronic and Obstructive Pulmonary Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Obstructive Pulmonary Disease, Cognitive Impairment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 24 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstructive lung diseases in 18-65 years old
Who may be able to join
- To be diagnosed with obstructive pulmonary disease,
- Have not experienced acute exacerbation in the last 3 months,
- Being between the ages of 18-65,
- Not having chronic pain problems,
- Volunteer for research,
- To be able to walk and cooperate.
Who cannot join
- To be able to diagnose neurological disorder,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
- Criteria for Non-Inclusion for healthy group
- To have any cardiopulmonary disease,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Ankara, Please Choose A State, 06100
About this study
Official title: Assessment of Cognitive Status, Pain, Functional Status, Postural Awareness, Respiratory Muscle Strength and Endurance in Obstructive Pulmonary Diseases
In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients. There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.
- Conditions
- Pain, Chronic, Obstructive Pulmonary Disease, Cognitive Impairment, Functional Disturbance
- Medical subject headings
- Chronic Pain, Lung Diseases, Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive lung diseases group | Not described | |
| Healthy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Pain Perception Threshold and Tolerance With Algometer
Measured: 01.01.2019-31.08.2019
Secondary outcomes (4)
Cognitive Function Assessment
Montreal Cognitive Assessment Test (MoCA)
Measured: 01.01.2019-31.08.2019
Functional capacity assesment
6 minute walk test
Measured: 01.01.2019-31.08.2019
Postural awareness assesment
Body Awareness Questionnare is a likert type questionnare and total score ranges from 18-126. Higher scores mean better body awareness level
Measured: 01.01.2019-31.08.2019
Respiratory muscle strength and endurance measurement
Mouth pressure measurement
Measured: 01.01.2019-31.08.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Jan 2019
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naciye Vardar-Yagli, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe UniversityMelda Saglam, PhD, Principal investigator, Hacettepe UniversityDeniz Inal Ince, Professor, Principal investigator, Hacettepe UniversityHulya Arikan, Professor, Principal investigator, Hacettepe UniversityNaciye Vardar Yagli, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048408
- Sponsor's protocol ID
- GO 18/109
- Status last verified
- Jul 2020
- First submitted
- 6 Aug 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Status, Pain, Functional Status, Postural Awareness, Respiratory Muscle Strength and Endurance in Obstructive Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT04048408
- Acronym / sponsor ID
- GO 18/109
- Conditions
- Pain, Chronic, Obstructive Pulmonary Disease, Cognitive Impairment, Functional Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 7 Aug 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.
In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients. There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive lung diseases group | – | – |
| Healthy group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive lung diseases in 18-65 years old
Key inclusion criteria (6 listed)
- To be diagnosed with obstructive pulmonary disease,
- Have not experienced acute exacerbation in the last 3 months,
- Being between the ages of 18-65,
- Not having chronic pain problems,
- Volunteer for research,
Key exclusion criteria (5 listed)
- To be able to diagnose neurological disorder,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
- Criteria for Non-Inclusion for healthy group
- To have any cardiopulmonary disease,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Perception
Time frame: 01.01.2019-31.08.2019
Pain Perception Threshold and Tolerance With Algometer
4 secondary outcomes
Cognitive Function Assessment
Time frame: 01.01.2019-31.08.2019
Functional capacity assesment
Time frame: 01.01.2019-31.08.2019
Postural awareness assesment
Time frame: 01.01.2019-31.08.2019
Respiratory muscle strength and endurance measurement
Time frame: 01.01.2019-31.08.2019
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 29 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
Melda Saglam, PhD principal investigator
Hacettepe University
Deniz Inal Ince, Professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Obstructive Pulmonary Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 29 Jul 2020. 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 Turkey (Türkiye). 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?
Pain Perception (time frame: 01.01.2019-31.08.2019). 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 29 Jul 2020.