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

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid; Dietary Modifications; Body Composition, Beneficial; Motor Activity; Inflammation; Physical Activity
• Interventions: Other: Mediterranean diet; Other: Dynamic exercise; Other: Control; Other: Dynamic exercise and Mediterranean diet

• Registration Number: NCT02900898
• Lead Sponsor: LILIA CASTILLO MARTINEz

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	Mediterranean diet	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.
Dynamic exercise	Dynamic exercise	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.
Control	Control	This group will not carry out interventions.
Dynamic exercise and Mediterranean diet	Dynamic exercise and Mediterranean diet	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.

Primary Outcome Measures

Name	Time	Method
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	24 weeks	Change in resistance, reactance, phase angle. Impedance vector analysis

Secondary Outcome Measures

Name	Time	Method
Change from baseline in disease activity by DAS28	24 weeks	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
Change from baseline in muscular strength	24 weeks	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
Change from baseline in joint mobility by goniometry	24 weeks	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
Change from baseline in physical capacity by 6 minute walk test	24 weeks	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
Change from baseline in inflammatory cytokines and chemokines by spectrophotometry	24 weeks	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

Trial Locations

Locations (1)

Juan Antonio Pineda Juárez; 🇲🇽 Mexico City, Tlalpan, Mexico