NCT05021068

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 19, 2021

Last Update Submit

August 24, 2021

Conditions

Keywords

copdposturerespiratory functiondyspnea

Outcome Measures

Primary Outcomes (1)

  • Spinal Structure and Mobility

    Spinal mouse measurement

    15 minutes (single application)

Secondary Outcomes (2)

  • Pulmonary Functions

    10 minutes (single application)

  • Dyspnea Severity

    5 minutes (single application)

Study Arms (2)

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.

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.

Other: Postural Assessment

Interventions

Spinal mouse measurement

Also known as: Respiratory Function Test, MMRC Dyspnea measurement
COPD PatientsControl Group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients over 18 years old

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

Izmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory InsufficiencyDyspneaRespiratory Aspiration

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

March 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations