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

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05552677
Collaborator
(none)
38
1
2
5
7.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multicomponent Training
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Clinical TrialRandomized Clinical Trial
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Effects of Multicomponent Training on Inflammation Parameters in Correlation With Muscle Quality and Function in Elderly Obese Woman
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group (CG)

Patients will recieve no intervention for the period of 12 weeks

Experimental: Exercise Group (EG)

Patients will undergo a 12 week multicomponent training program

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

Outcome Measures

Primary Outcome Measures

  1. Changes in inflamatory markers [12 weeks]

    Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, TNF-α, NFκβ, NLRP3, myonectin, SIRT1, sTNFR1, IL-10, IL-13, adiponectin

  2. Changes in muscle quality [12 weeks]

    Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention

Secondary Outcome Measures

  1. Changes in muscle function [12 weeks]

    Evaluate the muscle function trough the load test pre and post intervention

  2. Changes in metabolic parameters - fasting blood glucose [12 weeks]

    Changes in fasting blood glucose samples in pre and post intervention

  3. Changes in metabolic parameters - insulin sensitivity [12 weeks]

    Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention

  4. Changes in muscle remodeling peptides [12 weeks]

    Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention

  5. Body composition changes [12 weeks]

    Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA

  6. Changes of physical performance [12 weeks]

    Physical performance changes, evaluated through physical tests.

  7. Changes in blood myostatin [12 weeks]

    Changes in blood myostatin levels pre and post intervention

  8. Indirect calorimetry assessment [12 weeks]

    Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry

  9. Changes in metabolic parameters - lipid profile [12 weeks]

    Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ribeirão Preto Sp Brazil 14048-900

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Principal Investigator: Ellen C de Freitas, PhD, University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ellen Cristini de Freitas, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT05552677
Other Study ID Numbers:
  • Exercise_Inflammation
First Posted:
Sep 23, 2022
Last Update Posted:
Sep 23, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ellen Cristini de Freitas, Principal Investigator, University of Sao Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2022