Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease

• Sponsor: Izmir Katip Celebi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05021068
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Postural; Defect; Respiratory Function Impaired; Dyspnea	Other: Postural Assessment

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 98 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Investigation of The Relationship Between Spinal Structure and Mobility and Respiratory Functions in Chronic Obstructive Pulmonary Disease
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Spinal mouse measurement; Other Names: Respiratory Function Test MMRC Dyspnea measurement
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; Spinal mouse measurement; Other Names: Respiratory Function Test MMRC Dyspnea measurement

Outcome Measures

Primary Outcome Measures

1. Spinal Structure and Mobility [15 minutes (single application)]

   Spinal mouse measurement

Secondary Outcome Measures

1. Pulmonary Functions [10 minutes (single application)]

   Respiratory Function Test

2. Dyspnea Severity [5 minutes (single application)]

   Modified Medical Research Dyspnea Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital	İzmir		Turkey	35620

Sponsors and Collaborators

• Izmir Katip Celebi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilknur Naz, Assoc. Prof, Izmir Katip Celebi University
• ClinicalTrials.gov Identifier: NCT05021068
• Other Study ID Numbers: IKC1233
• First Posted: Aug 25, 2021
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ilknur Naz, Assoc. Prof, Izmir Katip Celebi University: copd; posture; respiratory function; dyspnea
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea; Respiratory Insufficiency

Study Results

No Results Posted as of Aug 30, 2021