Connective Tissue Diseases and Vitamin D Deficiency

NCT05065814 | Unknown

• 1 other identifier: 205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Connective Tissue Diseases

Keywords

connective tissue disease; muscle strength; exercise capacity

Outcome Measures

Primary Outcomes (2)

• Functional exercise capacity

  Functional exercise capacity will be evaluated with the 6-minute walk test according to the European Respiratory Society and American Thoracic Society (ATS/ERS) criteria.

  First day

• Peripheral muscle strength

  Shoulder flexors, shoulder abductors, knee extensors and hip flexors of the patients will be evaluated with a portable digital hand dynamometer.

  First day

Secondary Outcomes (6)

• Numerical Evaluation Scale-Pain

  First day

• Modified Medical Research Council Dyspnea Scale

  First day

• Hospital Anxiety and Depression Scale

  First day

• Fatigue Severity Scale

  First day

• International Physical Activity Questionnaire-short form

  First day

Study Arms (3)

Systemic lupus erythematosus group

OTHER

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.

Other: Systemic lupus erythematosus group

Systemic sclerosis group

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.

Other: Systemic sclerosis group

Healthy control group

OTHER

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

Other: Healthy control group

Interventions

Systemic lupus erythematosus group 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 lupus erythematosus group

Systemic sclerosis group 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.

Systemic sclerosis group

Healthy control group OTHER

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

Healthy control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Çankaya, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Deran OSKAY, Prof

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Fulden SARİ, doctorate

CONTACT

+90 5069654352; fuldensari@hotmail.com

Deran OSKAY, Prof

CONTACT

deranoskay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

TU (1)