An interventional study of Dynamic exercise and Mediterranean diet and Dynamic exercise in Arthritis, Rheumatoid, Dietary Modifications and Motor Activity, sponsored by LILIA CASTILLO MARTINEz. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by LILIA CASTILLO MARTINEz · Not applicable, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with LILIA CASTILLO MARTINEz as lead sponsor.
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Exclusion Criteria:
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.
Other: Dynamic exercise and Mediterranean diet
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.
Other: Dynamic exercise
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.
Other: Mediterranean diet
This group will not carry out interventions.
Other: Control
DE, MD
Also known as: Diet and physical treatment
DE
Also known as: Physical treatment
MD
Also known as: Diet treatment
Control
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
Plan to share: No
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