Inflammation Clinical Trial
Official title:
Effect of a Dynamic Exercise Program in Combination With a Mediterranean Diet on Body Composition, Strength, Inflammatory Markers, Joint Mobility and Disease Activity in Women With Rheumatoid Arthritis
NCT number | NCT02900898 |
Other study ID # | CLIC004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | December 2020 |
Verified date | February 2021 |
Source | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rheumatoid arthritis (RA) is a chronic autoimmune disease with metabolic alterations due mainly by the liberation of catabolic cytokines leading to changes in body composition as rheumatoid cachexia. Dynamic exercise (DE) has demonstrated to improve muscular, strength and joint function as well as inflammatory process. Also, a diet focused on the consumption of certain fatty acids like the Mediterranean is recommended to reduce inflammation. The aim of this study is to assess the effect of a dynamic exercise program in combination with a Mediterranean diet in strength, joint mobility and disease activity in women with RA.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients older than 18 years. - Women (nonpregnant). - Patients with confirmed RA and functional classification I - III. - Patients who voluntarily accept previously signed informed consent Exclusion Criteria: - Patients participating in other investigations. - Patients with chronic renal failure, cancer, HIV, heart failure. - Patients with inability to perform physical exercises. - Patients who make a structured exercise plan (rehabilitation) at the time of inclusion in the study. - Patients with systemic lupus erythematosus, psoriatic arthritis, gout, fibromyalgia, scleroderma, Sjögren's syndrome or some other autoimmune pathology. - Patients with functional class IV. - Patients with partial or total joint replacement. - Patients who are taking any dietary supplement at the time of inclusion in the study. - Patients who are treated with biological drugs. |
Country | Name | City | State |
---|---|---|---|
Mexico | Juan Antonio Pineda Juárez | Mexico City | Tlalpan |
Lead Sponsor | Collaborator |
---|---|
LILIA CASTILLO MARTINEz |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in body composition by bioelectric impedance analysis at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | Change in resistance, reactance, phase angle. Impedance vector analysis | 24 weeks | |
Secondary | Change from baseline in muscular strength | Change from baseline in muscular strength by hand dynamometry at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | 24 weeks | |
Secondary | Change from baseline in inflammatory cytokines and chemokines by spectrophotometry | Change from baseline in inflammatory cytokines and chemokines by spectrophotometry assay ELISA at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | 24 weeks | |
Secondary | Change from baseline in joint mobility by goniometry | Change from baseline in joint mobility by goniometry at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | 24 weeks | |
Secondary | Change from baseline in disease activity by DAS28 | Change from baseline in disease activity by DAS28 at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | 24 weeks | |
Secondary | Change from baseline in physical capacity by 6 minute walk test | Change from baseline in physical capacity by 6 minute walk test at 24 weeks after dynamic exercise program in conjunction with a diet based on the Mediterranean pattern | 24 weeks |
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