Connective Tissue Diseases and Vitamin D Deficiency

NCT ID: NCT05065814

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-07-01

Brief Summary

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Connective tissue disease (CTD) covers all heterogeneous and broad immunological diseases. These immunological diseases are characterized by inflammation, tissue damage, and abnormal repair. Disorders such as fibrotic tissue or loss of function are seen in the degeneration of the target organ. There is a complex relationship between genetic and environmental factors on the basis of these disorders.

Vitamin D deficiency has been frequently observed in autoimmune diseases such as systemic lupus erythematosus, diabetes mellitus, and rheumatoid arthritis. Vitamin D deficiency is primarily seen with musculoskeletal complaints and is an early warning of osteomalacia. Muscle weakness is most common in the trunk, shoulders and hips. It is characterized by difficulty in climbing stairs, getting up from sitting or lying position, feeling of heaviness in the legs, duck-like gait, difficulty getting up from a chair, fatigue easily, inability to lift objects with arms and hands. Patients experience decreased exercise capacity as a result of pain and muscle weakness. In addition, vitamin D deficiency causes smooth muscle contraction and an increase in airway inflammation. As a result, it was observed that the disease course and symptoms were more severe in CVD patients with vitamin D deficiency. In a study conducted with rheumatoid arthritis patients, the quality of life, physical activity and depression levels of patients with vitamin D deficiency were compared with the control group. The evaluation parameters of rheumatoid arthritis patients were worse than the control group. Vitamin D levels were compared with sleep, anxiety and depression levels in patients with systemic lupus erythematosus. A positive relationship was found between vitamin D deficiency and sleep disturbance level. It has been observed that the life expectancy of patients with connective tissue disease is significantly reduced compared to healthy ones. Exercise capacity and oxygen consumption decreased in these patients.

Detailed Description

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Outpatient connective tissue disease patients (systemic sclerosis and systemic lupus erythematosus) with stable medical conditions will be referred for physiotherapy and rehabilitation after being examined by the relevant physician. Physiotherapy evaluation will be made by the physiotherapist. In addition; healthy individuals who accepted and gave consent to participate in the study without any chronic disease for the healthy control group will be included in the study.

Conditions

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Connective Tissue Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Systemic lupus erythematosus group

Demographic information of systemic lupus erythematosus patients who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Group Type OTHER

Systemic lupus erythematosus group

Intervention Type OTHER

Demographic information of systemic lupus erythematosus who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Systemic sclerosis group

Demographic information of systemic sclerosis who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Group Type OTHER

Systemic sclerosis group

Intervention Type OTHER

Demographic information of Systemic sclerosis who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Healthy control group

Healthy individuals with no chronic diseases who agreed to participate in the study and gave their consent will be included in the study.

Group Type OTHER

Healthy control group

Intervention Type OTHER

Healthy individuals with no chronic diseases who agreed to participate in the study and gave their consent will be included in the study.

Interventions

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Systemic lupus erythematosus group

Demographic information of systemic lupus erythematosus who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Intervention Type OTHER

Systemic sclerosis group

Demographic information of Systemic sclerosis who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.

Intervention Type OTHER

Healthy control group

Healthy individuals with no chronic diseases who agreed to participate in the study and gave their consent will be included in the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with stable general condition treated with standard medical treatment
* Patients between the ages of 18-65

Exclusion Criteria

* Patients who cannot cooperate with the assessment
* Those who have orthopedic problems or neurological diseases that will affect the evaluation of functional capacity
* Patients with pneumonia or any acute infection at the time of assessment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Fulden Sarı

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deran OSKAY, Prof

Role: STUDY_DIRECTOR

Gazi University

Locations

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Gazi University

Çankaya, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fulden SARİ, doctorate

Role: CONTACT

+90 5069654352

Deran OSKAY, Prof

Role: CONTACT

Facility Contacts

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Fulden SARİ, doktorate

Role: primary

Other Identifiers

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205

Identifier Type: -

Identifier Source: org_study_id

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