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

Primary Purpose

Arthritis, Rheumatoid, Dietary Modifications, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Dynamic exercise and Mediterranean diet
Dynamic exercise
Mediterranean diet
Control
Sponsored by
LILIA CASTILLO MARTINEz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Juan Antonio Pineda Juárez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Dynamic exercise and Mediterranean diet

Dynamic exercise

Mediterranean diet

Control

Arm Description

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.

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.

This group will not carry out interventions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
August 24, 2016
Last Updated
February 8, 2021
Sponsor
LILIA CASTILLO MARTINEz
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1. Study Identification

Unique Protocol Identification Number
NCT02900898
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LILIA CASTILLO MARTINEz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Dietary Modifications, Motor Activity, Body Composition, Beneficial, Physical Activity, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic exercise and Mediterranean diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Dynamic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will not carry out interventions.
Intervention Type
Other
Intervention Name(s)
Dynamic exercise and Mediterranean diet
Other Intervention Name(s)
Diet and physical treatment
Intervention Description
DE, MD
Intervention Type
Other
Intervention Name(s)
Dynamic exercise
Other Intervention Name(s)
Physical treatment
Intervention Description
DE
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Other Intervention Name(s)
Diet treatment
Intervention Description
MD
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control
Primary Outcome Measure Information:
Title
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
Description
Change in resistance, reactance, phase angle. Impedance vector analysis
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in muscular strength
Description
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
Time Frame
24 weeks
Title
Change from baseline in inflammatory cytokines and chemokines by spectrophotometry
Description
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
Time Frame
24 weeks
Title
Change from baseline in joint mobility by goniometry
Description
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
Time Frame
24 weeks
Title
Change from baseline in disease activity by DAS28
Description
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
Time Frame
24 weeks
Title
Change from baseline in physical capacity by 6 minute walk test
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A Pineda Juárez, PhD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lilia Castillo Martínez, PhD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mariel Lozada Mellado, BSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Midori Ogata Medel, BSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rocío Cervantes Gaytán, BSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Hinojosa Azaola, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorge Alcocer Varela, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis Llorente Peters, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arturo Orea Tejeda, MD
Organizational Affiliation
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Official's Role
Study Director
Facility Information:
Facility Name
Juan Antonio Pineda Juárez
City
Mexico City
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36372851
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.
Results Reference
derived
PubMed Identifier
35548581
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.
Results Reference
derived

Learn more about this trial

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

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