NCT05552677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 15, 2022

Last Update Submit

September 20, 2022

Conditions

Keywords

anabolic resistanceobesityinflammationphysical exercise

Outcome Measures

Primary Outcomes (2)

  • 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

    12 weeks

  • Changes in muscle quality

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

    12 weeks

Secondary Outcomes (9)

  • Changes in muscle function

    12 weeks

  • Changes in metabolic parameters - fasting blood glucose

    12 weeks

  • Changes in metabolic parameters - insulin sensitivity

    12 weeks

  • Changes in muscle remodeling peptides

    12 weeks

  • Body composition changes

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control Group (CG)

NO INTERVENTION

Patients will recieve no intervention for the period of 12 weeks

Exercise Group (EG)

EXPERIMENTAL

Patients will undergo a 12 week multicomponent training program

Other: Multicomponent Training

Interventions

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

Exercise Group (EG)

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 30 and 40kg/m²;

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Related Publications (1)

  • Travieso SG, Ortiz GU, Abud GF, Villalba MM, Junqueira GP, Gomes MM, Marchini JS, Freitas EC. Effects of Multicomponent Training on Metabolic and Functional Health of Older Women With Obesity: A Randomized Clinical Trial. J Aging Phys Act. 2025 Aug 26:1-13. doi: 10.1123/japa.2024-0341. Online ahead of print.

MeSH Terms

Conditions

ObesityInflammationMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBehavior

Study Officials

  • Ellen C de Freitas, PhD

    University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia G Travieso, Specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 23, 2022

Study Start

August 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 30, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations