CClinicalTrials.gg
Status unknownNCT05552677Updated Sep 23, 2022

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

An interventional study of Multicomponent Training in Aging Disorder, Obesity and Inflammation, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Aging Disorder
  • Obesity
  • Inflammation

Browse trials for

Keywords

  • anabolic resistance
  • obesity
  • inflammation
  • physical exercise
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's planned enrollment of 38 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • BMI between 30 and 40kg/m²;

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
38 participants (estimated)

Study arms

  • 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

Interventions

  • OtherMulticomponent 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

06

What researchers measure

Primary outcomes

  1. Changes in inflamatory markers

    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

    Time frame: 12 weeks

  2. Changes in muscle quality

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

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in muscle function

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

    Time frame: 12 weeks

  2. Changes in metabolic parameters - fasting blood glucose

    Changes in fasting blood glucose samples in pre and post intervention

    Time frame: 12 weeks

  3. Changes in metabolic parameters - insulin sensitivity

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

    Time frame: 12 weeks

  4. Changes in muscle remodeling peptides

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

    Time frame: 12 weeks

  5. Body composition changes

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

    Time frame: 12 weeks

  6. Changes of physical performance

    Physical performance changes, evaluated through physical tests.

    Time frame: 12 weeks

  7. Changes in blood myostatin

    Changes in blood myostatin levels pre and post intervention

    Time frame: 12 weeks

  8. Indirect calorimetry assessment

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

    Time frame: 12 weeks

  9. Changes in metabolic parameters - lipid profile

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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
    Ribeirão Preto, Sp 14048-900, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05552677
Lead sponsor
University of Sao Paulo
Responsible party
Ellen Cristini de Freitas (Principal Investigator, University of Sao Paulo) — Principal investigator
First posted
Sep 23, 2022
Start date
Aug 1, 2022
Primary completion
Nov 1, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Sep 23, 2022

Study contacts

Sofia G Travieso, Specialist
Contact
sofia.travieso@usp.br
16988084179
Ellen C de Freitas, PhD
principal investigator · University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion