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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900898
• Other study ID #: CLIC004
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Dynamic exercise and Mediterranean diet
DE, MD
• Dynamic exercise
DE
• Mediterranean diet
MD
• Control
Control

Locations

Country	Name	City	State
Mexico	Juan Antonio Pineda Juárez	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
LILIA CASTILLO MARTINEz

Country where clinical trial is conducted

Mexico, 

Outcome

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