Exercise and Mediterranean Diet on Body Composition, Disease Activity and Inflammatory Markers in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by inflammation, joint pain, destruction of the synovial membranes and metabolic alterations due mainly by the liberation of tumor necrosis factor alpha and interleukin-1 beta mainly and leading to changes in body composition as rheumatoid cachexia, which is characterized by involuntary loss of muscular mass with or without loss of body weight and with or without gain of fat mass and therefore reducing physical activity and affecting nutrition. Alternative therapies that could improve these metabolical changes are Dynamic exercise (DE) which has demonstrated to improve muscular function and muscular strength, as well as joint mobility and joint inflammatory markers without negative effects on RA. Also, Mediterranean diet (MD) which is recommended to reduce inflammation by the high intake of monounsaturated and polyunsaturated and low in saturated fats. Previous studies report the benefits of nutritional interventions but in the majority of the cases therapies are based on specific foods and not in the form of diet. Likewise, physical interventions are different regarding in time and type of movement. However both interventions have shown ambiguous findings in terms of body composition (mainly) and which prevents drawing conclusions and generate recommendations on the implementation of these therapies (in combination). As far as the investigators know, no studies evaluating the effect of a diet and exercise combined. Thus the aim of this study is to assess the effect of DE program in combination with a MD on body composition, strength, joint mobility and disease activity in women with RA.

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

Conditions
-----------------
Arthritis, Rheumatoid, Dietary Modifications, Motor Activity, Body Composition, Beneficial, Physical Activity, Inflammation

Intervention / Treatment
-----------------
* Other: Dynamic exercise and Mediterranean diet
* Other: Dynamic exercise
* Other: Mediterranean diet
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic exercise and Mediterranean diet<br>DE: divided in stretch: arms, hands, legs, knees, for 20 seconds (s), resting 5, warming and flexion: making small circles forward and backward for 20 s, resting 5, DE: resistance (contraction, twisting) using therapeutic leagues with 20 repetitions, resting 10 s. Aerobic part will perform in a treadmill by 20 minutes (monitoring blood pressure and heart rate) and relaxation: involved the stretching part. MD: Individualized diet (energy expenditure) according to age, ideal weight and height. Distribution of macronutrients will be 50% carbohydrates, 30% lipids and 20% of proteins. This diet is according to the Mediterranean diet patterns and consist in five meals: breakfast, snack, principal meal, snack and dinner. All recommended meals include type of food and method of preparation. | Other: Dynamic exercise and Mediterranean diet<br>* DE, MD<br>* Other names: Diet and physical treatment;|
| Experimental: Dynamic exercise<br>DE: divided in stretch: arms, hands, legs, knees, for 20 seconds (s), resting 5, warming and flexion: making small circles forward and backward for 20 s, resting 5, DE: resistance (contraction, twisting) using therapeutic leagues with 20 repetitions, resting 10 s. Aerobic part will perform in a treadmill by 20 minutes (monitoring blood pressure and heart rate) and relaxation: involved the stretching part. | Other: Dynamic exercise<br>* DE<br>* Other names: Physical treatment;|
| Experimental: Mediterranean diet<br>MD: Individualized diet (energy expenditure) according to age, ideal weight and height. Distribution of macronutrients will be 50% carbohydrates, 30% lipids and 20% of proteins. This diet is according to the Mediterranean diet patterns and consist in five meals: breakfast, snack, principal meal, snack and dinner. All recommended meals include type of food and method of preparation. | Other: Mediterranean diet<br>* MD<br>* Other names: Diet treatment;|
| Active Comparator: Control<br>This group will not carry out interventions. | Other: Control<br>* Control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |