- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552677
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
Conditions
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
- Name: Sofia G Travieso, Specialist
- Phone Number: 16988084179
- Email: sofia.travieso@usp.br
Study Locations
-
-
Sp
-
Ribeirão Preto, Sp, Brazil, 14048-900
- Recruiting
- University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
-
Contact:
- Ellen C de Freitas, PhD
- Phone Number: +55 16 3602-0345
- Email: ellenfreitas@usp.br
-
-
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.
Sponsor
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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