Clinical trial NCT05065814: Connective Tissue Diseases and Vitamin D Deficiency
Official title: The Effect of Vitamin D Deficiency on Exercise Capacity and Peripheral Muscle Strength
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Connective Tissue Diseases
Keywords: connective tissue disease
muscle strength
exercise capacity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
Secondary outcomes:
measure: Numerical Evaluation Scale-Pain
timeFrame: First day
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: First day
measure: Hospital Anxiety and Depression Scale
timeFrame: First day
measure: Fatigue Severity Scale
timeFrame: First day
measure: International Physical Activity Questionnaire-short form
timeFrame: First day
measure: Short-form 36
timeFrame: First day
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Gazi University
state: Ankara
Study officials:
affiliation: Gazi University
name: Deran OSKAY, Prof
role: STUDY_DIRECTOR
References: