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Arthritis, RheumatoidNCT02900898

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

A study testing Dynamic exercise and Mediterranean diet, Dynamic exercise and Mediterranean diet in people with Arthritis, Rheumatoid and Dietary Modifications, run by LILIA CASTILLO MARTINEz at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Dynamic exercise and Mediterranean diet, Dynamic exercise and Mediterranean diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteMexico
Study dates
Aug 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years.
  • Women (nonpregnant).
  • Patients with confirmed RA and functional classification I - III.
  • Patients who voluntarily accept previously signed informed consent

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Juan Antonio Pineda Juárez

    Mexico City, Tlalpan, 14080

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Dynamic exercise and Mediterranean diet, Dynamic exercise, Mediterranean diet, Control
Medical subject headings
Arthritis, Rheumatoid, Motor Activity, Glucocorticoid Receptor Deficiency, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic exercise and Mediterranean dietOther

    Also called Diet and physical treatment

    DE, MD

  • Dynamic exerciseOther

    Also called Physical treatment

    DE

  • Mediterranean dietOther

    Also called Diet treatment

    MD

  • ControlOther

    Control

Study groups in NCT02900898
Study groupRoleWhat they receive
Dynamic exercise and Mediterranean dietExperimentalDE: 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.
Receives: Other: Dynamic exercise and Mediterranean diet
Dynamic exerciseExperimentalDE: 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.
Receives: Other: Dynamic exercise
Mediterranean dietExperimentalMD: 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.
Receives: Other: Mediterranean diet
ControlActive comparatorThis group will not carry out interventions.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Measured: 24 weeks

Secondary outcomes (5)

  1. 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

    Measured: 24 weeks

  2. 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

    Measured: 24 weeks

  3. 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

    Measured: 24 weeks

  4. 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

    Measured: 24 weeks

  5. 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02900898
Sponsor's protocol ID
CLIC004
Status last verified
Feb 2021
First submitted
24 Aug 2016
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36372851

  • 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.

    PubMed 35548581

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic exercise and Mediterranean diet, Dynamic exercise and Mediterranean diet in people with Arthritis, Rheumatoid and Dietary Modifications, run by LILIA CASTILLO MARTINEz at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02900898, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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