COPDNCT05021068
Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease
An observational study of COPD and Postural; Defect, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients. The aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Postural; Defect, Respiratory Function Impaired
- What is being tested?
- Postural Assessment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2021
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: COPD patients over 18 years old
Who may be able to join
- Volunteer to participate in the study
- Be over 18 years old
- Being clinically stable
- Not having a COPD attack in the last 3 months at least
Who cannot join
- Refusing to participate in the research
- Having had spinal surgery Presence of back and shoulder pain
- Idiopathic scoliosis
- Ankylosing spondylitis
- Presence of respiratory disease other than COPD
- Difficulty understanding verbal commands
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Izmir, 35620
About this study
Official title: Investigation of The Relationship Between Spinal Structure and Mobility and Respiratory Functions in Chronic Obstructive Pulmonary Disease
In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.
The aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease characterized by irreversible airway limitation. In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.It has been observed that balance systems, functional balance tests, posturography, posture assessment systems, force platform and inclinometer measurements are used in studies on postural control assessment in COPD patients.There are a limited number of studies in which devices that objectively present the degree of deviation in spinal curves are used in patients with COPD, and posture and lung volume and capacities are evaluated.
Therefore, the aim of this study is to investigate the changes in spine structure and mobility in COPD patients and to reveal their relationship with static and dynamic lung volumes and capacities.
- Conditions
- COPD, Postural; Defect, Respiratory Function Impaired, Dyspnea
- Being tested
- Postural Assessment
- Keywords
- copd, posture, respiratory function, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Dyspnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural AssessmentOther
Also called Respiratory Function Test, MMRC Dyspnea measurement
Spinal mouse measurement
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | The respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded.
Spinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed.
Patients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score. Receives: Other: Postural Assessment | |
| Control Group | The respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded.
Spinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed.
Patients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score. Receives: Other: Postural Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Structure and Mobility
Spinal mouse measurement
Measured: 15 minutes (single application)
Secondary outcomes (2)
Pulmonary Functions
Respiratory Function Test
Measured: 10 minutes (single application)
Dyspnea Severity
Modified Medical Research Dyspnea Scale
Measured: 5 minutes (single application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Mar 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
- Target duration
- 1 Day
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
- NCT05021068
- Sponsor's protocol ID
- IKC1233
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Relationship Between Spinal Structure and Mobility and Respiratory Functions in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05021068
- Acronym / sponsor ID
- IKC1233
- Conditions
- COPD, Postural; Defect, Respiratory Function Impaired, Dyspnea
- Keywords
- copd, posture, respiratory function, dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 25 Aug 2021 (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 recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.
The aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease characterized by irreversible airway limitation. In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.It has been observed that balance systems, functional balance tests, posturography, posture assessment systems, force platform and inclinometer measurements are used in studies on postural control assessment in COPD patients.There are a limited number of studies in which devices that objectively present the degree of deviation in spinal curves are used in patients with COPD, and posture and lung volume and capacities are evaluated.
Therefore, the aim of this study is to investigate the changes in spine structure and mobility in COPD patients and to reveal their relationship with static and dynamic lung volumes and capacities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | – | Other: Postural AssessmentThe respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded. Spinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed. Patients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score. |
| Control Group | – | Other: Postural AssessmentThe respiratory functions of the participants will be measured in accordance with the ATS-ERS criteria. After measurement; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), inspiratory capacity (IC), vital capacity (VC) parameters will be recorded. Spinal structure and mobility will be evaluated with the Spinal Mouse device in the sagittal and frontal planes in standing and sitting positions. For the sagittal plane, the measurements were first in the neutral, then in the maximum flexion and extension positions, for the frontal plane; neutral, right and left lateral flexions will be performed. Patients will be asked to mark the level of activity that causes dyspnea on the Medical Council Research Scale (MMRC) Dyspnea Score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COPD patients over 18 years old
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- Be over 18 years old
- Being clinically stable
- Not having a COPD attack in the last 3 months at least
Key exclusion criteria (6 listed)
- Refusing to participate in the research
- Having had spinal surgery Presence of back and shoulder pain
- Idiopathic scoliosis
- Ankylosing spondylitis
- Presence of respiratory disease other than COPD
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 |
|---|---|---|
| Postural AssessmentAlso: Respiratory Function Test, MMRC Dyspnea measurementSpinal mouse measurement | Other | COPD Patients, Control Group |
Primary outcome
Spinal Structure and Mobility
Time frame: 15 minutes (single application)
Spinal mouse measurement
2 secondary outcomes
Pulmonary Functions
Time frame: 10 minutes (single application)
Dyspnea Severity
Time frame: 5 minutes (single application)
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 30 Aug 2021.
- Individual participant dataSharing planned: No
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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.
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 COPD and Postural; Defect, run by Izmir Katip Celebi 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 4 inclusion and 6 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 30 Aug 2021. 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?
Spinal Structure and Mobility (time frame: 15 minutes (single application)). 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 30 Aug 2021.