Effects of Multicomponent Training on Inflammation Parameters and Muscle Quality in Elderly Obese Woman

Obesity Clinical Trial

Official title:

Effects of Multicomponent Training on Inflammation Parameters in Correlation With Muscle Quality and Function in Elderly Obese Woman

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552677
• Other study ID #: Exercise_Inflammation
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2022
• Source: University of Sao Paulo
• Contact: Sofia G Travieso, Specialist
• Phone: 16988084179
• Email: sofia.travieso[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Population aging worldwide has increased substantially in recent years. In order to prevent disabling diseases and improve the quality of life, it is necessary to understand the conditions related to the health of this specific population. One of the known alterations that occur in the body is the increased low-grade systemic inflammatory process, anabolic resistance, and muscle catabolism. These conditions can negatively interfere with muscle quality and functionality. However, the maintenance of the metabolic and physical functionality of muscle tissue can be preserved by performing physical exercises throughout life because of its anti-inflammatory mechanisms. In the present study, a multicomponent training program that combines aerobic, strength, balance, and flexibility capacities was used. The hypothesis is that performing this type of physical exercise will mitigate meta-inflammation and its negative effects, in addition to stimulating anabolic signals and reducing insulin resistance present in anabolic resistance, leading to improved quality and muscle functionality in elderly women with obesity.

Description:

Population aging worldwide has increased substantially in recent years. Therefore, it is necessary to know and understand the conditions related to the health of this specific population in order to prevent disabling diseases and improve the quality of life. One of the major concerns associated with the senescence process is the various physiological changes that can occur in the body. Body composition changes, bone loss, muscle catabolism, an increased low-grade systemic inflammatory process, and anabolic resistance all contribute to the development and/or worsening of several aging-related diseases. In particular, chronic low-grade inflammation, also known as meta-inflammation, can negatively interfere with muscle quality and functionality by reducing the muscle's ability to use energy substrates, amino acids, and perform protein synthesis. However, the maintenance of the metabolic and physical functionality of muscle tissue can be preserved by performing physical exercise throughout life because physical exercise can stimulate anti-inflammatory mechanisms. In the present study, a multicomponent training program will be used, which consists of training that combines aerobic, strength, balance, and flexibility capacities, and is capable of reducing inflammatory parameters and increasing physical and muscular capacities, resulting in a better quality of life and being thus attractive to this specific population. In view of this approach, the hypothesis is that performing this type of physical exercise is capable of mitigating meta-inflammation and its negative effects, in addition to stimulating anabolic signals and reducing insulin resistance present in anabolic resistance, leading to improved quality and muscle functionality in elderly women with obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 30, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI between 30 and 40kg/m²;

Exclusion Criteria:

• alcoholics
• smokers
• diseases that prevents the practice of physical activity
• medical impediment to the practice of physical exercise throughout the study
• infectious diseases
• coronary diseases
• chronic kidney diseases
• chronic use of corticosteroids
• chronic use of immunomodulators
• undergoing nutritional monitoring or weight loss treatment
• score =13 for cognitive screening on the Mini-Mental State Examination (MMSE)

Related Conditions & MeSH terms

• Aging Disorder
• Inflammation
• Obesity

Intervention

Other:
• Multicomponent Training
Participants will perform a multicomponent training that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 12 weeks

Locations

Country	Name	City	State
Brazil	University of São Paulo, School of Physical Education and Sports of Ribeirão Preto	Ribeirão Preto	Sp

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in inflamatory markers	Evaluate the inflamatory markers PCR, IL-1ß, IL-6, IL-10, IL-15, TNF-a, NF?ß, NLRP3, myonectin, SIRT1, sTNFR1, IL-10, IL-13, adiponectin	12 weeks
Primary	Changes in muscle quality	Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention	12 weeks
Secondary	Changes in muscle function	Evaluate the muscle function trough the load test pre and post intervention	12 weeks
Secondary	Changes in metabolic parameters - fasting blood glucose	Changes in fasting blood glucose samples in pre and post intervention	12 weeks
Secondary	Changes in metabolic parameters - insulin sensitivity	Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention	12 weeks
Secondary	Changes in muscle remodeling peptides	Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention	12 weeks
Secondary	Body composition changes	Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA	12 weeks
Secondary	Changes of physical performance	Physical performance changes, evaluated through physical tests.	12 weeks
Secondary	Changes in blood myostatin	Changes in blood myostatin levels pre and post intervention	12 weeks
Secondary	Indirect calorimetry assessment	Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry	12 weeks
Secondary	Changes in metabolic parameters - lipid profile	Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention	12 weeks