Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02900898
Other study ID # CLIC004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date December 2020

Study information

Verified date February 2021
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Other:
Dynamic exercise and Mediterranean diet
DE, MD
Dynamic exercise
DE
Mediterranean diet
MD
Control
Control

Locations

Country Name City State
Mexico Juan Antonio Pineda Juárez Mexico City Tlalpan

Sponsors (1)

Lead Sponsor Collaborator
LILIA CASTILLO MARTINEz

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 weeks
Secondary 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 24 weeks
Secondary 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 24 weeks
Secondary 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 24 weeks
Secondary 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 24 weeks
Secondary 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 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A