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

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ClinicalTrials.gov Identifier: NCT02900898
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Dietary Modifications Motor Activity Body Composition, Beneficial Physical Activity Inflammation Other: Dynamic exercise and Mediterranean diet Other: Dynamic exercise Other: Mediterranean diet Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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Arms and Interventions
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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 Name: 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 Name: 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 Name: Diet treatment
Active Comparator: Control
This group will not carry out interventions.
 Other: Control
Control


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 24 weeks ]
    Change in resistance, reactance, phase angle. Impedance vector analysis


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900898


Contacts
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Contact: Lilia Castillo Martínez, PhD cam7125@gmail.com
Contact: Juan A Pineda Juárez, PhD pinedaj.ja@gmail.com

Locations
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Mexico
Juan Antonio Pineda Juárez Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: Lilia Castillo Martínez, PhD       cam7125@gmail.com   
Contact: Mariel Lozada Mellado, BS       mlozada48@gmail.com   
Sponsors and Collaborators
LILIA CASTILLO MARTINEz
Investigators
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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 Cosío Villegas
More Information
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Responsible Party: LILIA CASTILLO MARTINEz, Medical Research Scientist, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02900898     History of Changes
Other Study ID Numbers: CLIC004
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes