Clinical trial NCT02900898: Exercise and Mediterranean Diet on Body Composition, Disease Activity and Inflammatory Markers in Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Dietary Modifications
Motor Activity
Body Composition, Beneficial
Physical Activity
Inflammation
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in muscular strength
timeFrame: 24 weeks
measure: Change from baseline in inflammatory cytokines and chemokines by spectrophotometry
timeFrame: 24 weeks
measure: Change from baseline in joint mobility by goniometry
timeFrame: 24 weeks
measure: Change from baseline in disease activity by DAS28
timeFrame: 24 weeks
measure: Change from baseline in physical capacity by 6 minute walk test
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Juan Antonio Pineda Juárez
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Juan A Pineda Juárez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Lilia Castillo Martínez, PhD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Mariel Lozada Mellado, BSc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Midori Ogata Medel, BSc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Rocío Cervantes Gaytán, BSc
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Andrea Hinojosa Azaola, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Jorge Alcocer Varela, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Luis Llorente Peters, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
name: Arturo Orea Tejeda, MD
role: STUDY_DIRECTOR
References:
citation: Ogata-Medel M, Llorente L, Hinojosa-Azaola A, Lozada-Mellado M, Pineda-Juarez JA, Rocha-Gonzalez HI, Castillo-Martinez L. Cachexia measured by bioelectrical impedance vector analysis and risk of infection in women with rheumatoid arthritis. Clin Rheumatol. 2023 Feb;42(2):391-397. doi: 10.1007/s10067-022-06431-5. Epub 2022 Nov 14.
citation: Lozada-Mellado M, Llorente L, Hinojosa-Azaola A, Garcia-Morales JM, Ogata-Medel M, Alcocer-Varela J, Pineda-Juarez JA, Castillo-Martinez L. Comparison of the Impacts of a Dynamic Exercise Program vs. a Mediterranean Diet on Serum Cytokine Concentrations in Women With Rheumatoid Arthritis. A Secondary Analysis of a Randomized Clinical Trial. Front Nutr. 2022 Apr 25;9:834824. doi: 10.3389/fnut.2022.834824. eCollection 2022.