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

NCT02900898 | Completed DMC

• 1 other identifier: CLIC004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in muscular strength

  24 weeks

• Change from baseline in inflammatory cytokines and chemokines by spectrophotometry

  24 weeks

• Change from baseline in joint mobility by goniometry

  24 weeks

• Change from baseline in disease activity by DAS28

  24 weeks

• Change from baseline in physical capacity by 6 minute walk test

  24 weeks

Study Arms (4)

Dynamic exercise and Mediterranean diet

EXPERIMENTAL

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

Dynamic exercise

EXPERIMENTAL

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

Mediterranean diet

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

This group will not carry out interventions.

Other: Control

Interventions

Dynamic exercise and Mediterranean diet OTHER

DE, MD

Also known as: Diet and physical treatment

Dynamic exercise and Mediterranean diet

Dynamic exercise OTHER

DE

Also known as: Physical treatment

Dynamic exercise

Mediterranean diet OTHER

MD

Also known as: Diet treatment

Mediterranean diet

Control OTHER

Control

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Women (nonpregnant).
• Patients with confirmed RA and functional classification I - III.
• Patients who voluntarily accept previously signed informed consent

You may not qualify if:

• Patients participating in other investigations.
• Patients with chronic renal failure, cancer, HIV, heart failure.
• Patients with inability to perform physical exercises.
• 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 treated with biological drugs.

Sponsors & Collaborators

• LILIA CASTILLO MARTINEz: lead

Study Sites (1)

Juan Antonio Pineda Juárez

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (2)

• 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.

  PMID: 36372851 DERIVED

• 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.

  PMID: 35548581 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity; Glucocorticoid Receptor Deficiency; Inflammation

Interventions

Diet, Mediterranean; Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Juan A Pineda Juárez, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Lilia Castillo Martínez, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

• Mariel Lozada Mellado, BSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

• Midori Ogata Medel, BSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

• Rocío Cervantes Gaytán, BSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

• Andrea Hinojosa Azaola, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

• Jorge Alcocer Varela, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

• Luis Llorente Peters, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

• Arturo Orea Tejeda, MD

  Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Research Scientist

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 14, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)