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

September 20, 2022 updated by: Ellen Cristini de Freitas, University of Sao Paulo

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Sp
      • Ribeirão Preto, Sp, Brazil, 14048-900
        • Recruiting
        • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in inflamatory markers
Time Frame: 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
12 weeks
Changes in muscle quality
Time Frame: 12 weeks
Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in muscle function
Time Frame: 12 weeks
Evaluate the muscle function trough the load test pre and post intervention
12 weeks
Changes in metabolic parameters - fasting blood glucose
Time Frame: 12 weeks
Changes in fasting blood glucose samples in pre and post intervention
12 weeks
Changes in metabolic parameters - insulin sensitivity
Time Frame: 12 weeks
Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention
12 weeks
Changes in muscle remodeling peptides
Time Frame: 12 weeks
Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention
12 weeks
Body composition changes
Time Frame: 12 weeks
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
12 weeks
Changes of physical performance
Time Frame: 12 weeks
Physical performance changes, evaluated through physical tests.
12 weeks
Changes in blood myostatin
Time Frame: 12 weeks
Changes in blood myostatin levels pre and post intervention
12 weeks
Indirect calorimetry assessment
Time Frame: 12 weeks
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry
12 weeks
Changes in metabolic parameters - lipid profile
Time Frame: 12 weeks
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exercise_Inflammation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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