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Completed

NCT Number: NCT02900898

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic exercise and Mediterranean diet

Other

DE, MD

Other names: Diet and physical treatment

Dynamic exercise

Other

DE

Other names: Physical treatment

Mediterranean Diet

Other

MD

Other names: Diet treatment

Control

Other

Control

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

    Time frame: 24 weeks

    Change in resistance, reactance, phase angle. Impedance vector analysis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

LILIA CASTILLO MARTINEz

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2016
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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