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

February 8, 2021 updated by: LILIA CASTILLO MARTINEz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Juan Antonio Pineda Juárez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Dynamic exercise and Mediterranean diet
DE, MD
Other Names:
  • Diet and physical treatment
Experimental: 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.
Other: Dynamic exercise
DE
Other Names:
  • Physical treatment
Experimental: 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.
Other: Mediterranean diet
MD
Other Names:
  • Diet treatment
Active Comparator: Control
This group will not carry out interventions.
Other: Control
Control

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LILIA CASTILLO MARTINEz

Investigators

  • Principal Investigator: Juan A Pineda Juárez, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Director: Lilia Castillo Martínez, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Study Chair: 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 Director: 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 Cosio Villegas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIC004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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