Effects of Multicomponent Training on Inflammation Parameters and Muscle Quality in Elderly Obese Woman
Primary Purpose
Aging Disorder, Obesity, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multicomponent Training
Sponsored by
About this trial
This is an interventional health services research trial for Aging Disorder focused on measuring anabolic resistance, obesity, inflammation, physical exercise
Eligibility Criteria
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)
Sites / Locations
- University of São Paulo, School of Physical Education and Sports of Ribeirão PretoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group (CG)
Exercise Group (EG)
Arm Description
Patients will recieve no intervention for the period of 12 weeks
Patients will undergo a 12 week multicomponent training program
Outcomes
Primary Outcome Measures
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
Changes in muscle quality
Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention
Secondary Outcome Measures
Changes in muscle function
Evaluate the muscle function trough the load test pre and post intervention
Changes in metabolic parameters - fasting blood glucose
Changes in fasting blood glucose samples in pre and post intervention
Changes in metabolic parameters - insulin sensitivity
Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention
Changes in muscle remodeling peptides
Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention
Body composition changes
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Changes of physical performance
Physical performance changes, evaluated through physical tests.
Changes in blood myostatin
Changes in blood myostatin levels pre and post intervention
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry
Changes in metabolic parameters - lipid profile
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Full Information
NCT ID
NCT05552677
First Posted
September 15, 2022
Last Updated
September 20, 2022
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05552677
Brief Title
Effects of Multicomponent Training on Inflammation Parameters and Muscle Quality in Elderly Obese Woman
Official Title
Effects of Multicomponent Training on Inflammation Parameters in Correlation With Muscle Quality and Function in Elderly Obese Woman
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Disorder, Obesity, Inflammation
Keywords
anabolic resistance, obesity, inflammation, physical exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
Patients will recieve no intervention for the period of 12 weeks
Arm Title
Exercise Group (EG)
Arm Type
Experimental
Arm Description
Patients will undergo a 12 week multicomponent training program
Intervention Type
Other
Intervention Name(s)
Multicomponent Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in inflamatory markers
Description
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
Title
Changes in muscle quality
Description
Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in muscle function
Description
Evaluate the muscle function trough the load test pre and post intervention
Time Frame
12 weeks
Title
Changes in metabolic parameters - fasting blood glucose
Description
Changes in fasting blood glucose samples in pre and post intervention
Time Frame
12 weeks
Title
Changes in metabolic parameters - insulin sensitivity
Description
Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention
Time Frame
12 weeks
Title
Changes in muscle remodeling peptides
Description
Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention
Time Frame
12 weeks
Title
Body composition changes
Description
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Time Frame
12 weeks
Title
Changes of physical performance
Description
Physical performance changes, evaluated through physical tests.
Time Frame
12 weeks
Title
Changes in blood myostatin
Description
Changes in blood myostatin levels pre and post intervention
Time Frame
12 weeks
Title
Indirect calorimetry assessment
Description
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry
Time Frame
12 weeks
Title
Changes in metabolic parameters - lipid profile
Description
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia G Travieso, Specialist
Phone
16988084179
Email
sofia.travieso@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen C de Freitas, PhD
Organizational Affiliation
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
City
Ribeirão Preto
State/Province
Sp
ZIP/Postal Code
14048-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen C de Freitas, PhD
Phone
+55 16 3602-0345
Email
ellenfreitas@usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Multicomponent Training on Inflammation Parameters and Muscle Quality in Elderly Obese Woman
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