Connective Tissue Diseases and Vitamin D Deficiency

The Effect of Vitamin D Deficiency on Exercise Capacity and Peripheral Muscle Strength

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.

Study Overview

• Status: Recruiting
• Conditions: Connective Tissue Diseases
• Intervention / Treatment: Other: Systemic lupus erythematosus group; Other: Systemic sclerosis group; Other: Healthy control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey
      • Recruiting
      • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: 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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire-short form	Physical activity level was evaluated with Turkish valid and reliable International Physical Activity (IPAQ) questionnaire. The questionnaire consisting of 7 questions gives information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered as a separate question. A score is obtained in total score metabolic equivalent (MET)-minutes. According to the result, physical activity level is classified as 'inactive', 'minimally active' and 'very active'.	First day
Hospital Anxiety and Depression Scale	A valid and reliable Turkish Hospital Anxiety and Depression Scale (HADS) was used to determine the anxiety and depression levels of the patients. In the questionnaire consisting of a total of 14 questions, odd-numbered questions assess anxiety and even-numbered questions assess depression. It has two subgroups, anxiety (HADS-A) and depression (HADS-D). The lowest score that patients can get from both subgroups is 0, and the highest score is 21.	First day
Numerical Evaluation Scale-Pain	The Numeric Rating Scale (NRS) was used to determine the pain level of the patients at rest, activity and at night. Patients are asked to mark the numbers between 0 and 10 at the time of assessment, in terms of rest, activity and night pain.	First day
Modified Medical Research Council Dyspnea Scale	Assessment of dyspnea was assessed with the Modified Medical Research Council (MMRC) dyspnea scale. The MMRC is a category scale consisting of 5 statements about dyspnea, scored between 0-4.	First day
Fatigue Severity Scale	It will be evaluated with the Fatigue Severity Scale (FSS). It is a scale used by the individual to determine the perception of fatigue. The scale consists of nine items, each item is scored between 1-7. An increase in the total score obtained from the scale indicates that the severity of fatigue of the individual increases.	First day
Short-form 36	Quality of life will be evaluated with the Short-form 36 (SF-36), which is completed considering the last 4 weeks. SF-36 questionnaire; It includes a total of 36 questions in eight subgroups: physical function, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health. Separate scores are calculated for eight subgroups. SF-36 evaluates the negative and positive aspects of the general health condition together. Subgroup scores range from 0 to 100, with a high score indicating good health.	First day

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (ACTUAL): October 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: muscle strength; exercise capacity; connective tissue disease
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Connective Tissue Diseases
• Other Study ID Numbers: 205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No