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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT02900898 |
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Date of registration:
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24/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Exercise and Mediterranean Diet on Body Composition, Disease Activity and Inflammatory Markers in Rheumatoid Arthritis
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Scientific title:
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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 |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02900898 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Mariel Lozada Mellado, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Juan A Pineda Juárez, PhD |
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Address:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Rocío Cervantes Gaytán, BSc |
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Address:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Lilia Castillo Martínez, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Arturo Orea Tejeda, MD |
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Address:
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Email:
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Affiliation:
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Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas |
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Name:
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Andrea Hinojosa Azaola, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Jorge Alcocer Varela, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Luis Llorente Peters, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Name:
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Midori Ogata Medel, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Dietary Modifications
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Physical Activity
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Motor Activity
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Body Composition, Beneficial
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Inflammation
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Intervention(s)
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Other: Dynamic exercise and Mediterranean diet
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Other: Mediterranean diet
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Other: Dynamic exercise
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Other: Control
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change from baseline in joint mobility by goniometry
[Time Frame: 24 weeks]
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Change from baseline in disease activity by DAS28
[Time Frame: 24 weeks]
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Change from baseline in muscular strength
[Time Frame: 24 weeks]
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Change from baseline in physical capacity by 6 minute walk test
[Time Frame: 24 weeks]
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Change from baseline in inflammatory cytokines and chemokines by spectrophotometry
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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