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Connective Tissue Diseases and Vitamin D Deficiency

Primary Purpose

Connective Tissue Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Systemic lupus erythematosus group
Systemic sclerosis group
Healthy control group
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Connective Tissue Diseases focused on measuring connective tissue disease, muscle strength, exercise capacity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Systemic lupus erythematosus group

Systemic sclerosis group

Healthy control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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'.
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.

Full Information

First Posted
July 15, 2021
Last Updated
October 1, 2021
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05065814
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Connective Tissue Diseases
Keywords
connective tissue disease, muscle strength, exercise capacity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic lupus erythematosus group
Arm Type
Other
Arm Description
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.
Arm Title
Systemic sclerosis group
Arm Type
Other
Arm Description
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.
Arm Title
Healthy control group
Arm Type
Other
Arm Description
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
Intervention Name(s)
Systemic lupus erythematosus group
Intervention Description
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
Intervention Name(s)
Systemic sclerosis group
Intervention Description
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
Intervention Name(s)
Healthy control group
Intervention Description
Healthy individuals with no chronic diseases who agreed to participate in the study and gave their consent will be included in the study.
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
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.
Time Frame
First day
Title
Peripheral muscle strength
Description
Shoulder flexors, shoulder abductors, knee extensors and hip flexors of the patients will be evaluated with a portable digital hand dynamometer.
Time Frame
First day
Secondary Outcome Measure Information:
Title
Numerical Evaluation Scale-Pain
Description
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.
Time Frame
First day
Title
Modified Medical Research Council Dyspnea Scale
Description
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.
Time Frame
First day
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
First day
Title
Fatigue Severity Scale
Description
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.
Time Frame
First day
Title
International Physical Activity Questionnaire-short form
Description
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'.
Time Frame
First day
Title
Short-form 36
Description
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.
Time Frame
First day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fulden SARİ, doctorate
Phone
+90 5069654352
Email
fuldensari@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deran OSKAY, Prof
Email
deranoskay@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran OSKAY, Prof
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Çankaya
State/Province
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulden SARİ, doktorate
Email
fuldensari@hotmail.com

12. IPD Sharing Statement

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Connective Tissue Diseases and Vitamin D Deficiency

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