Aging DisorderNCT05552677
Effects of Multicomponent Training on Inflammation Parameters and Muscle Quality in Elderly Obese Woman
A study testing Multicomponent Training in people with Aging Disorder and Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Aging Disorder, Obesity, Inflammation
- What is being tested?
- Multicomponent Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 30 and 40kg/m²;
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
Ellen C de Freitas, PhD, +55 16 3602-0345, ellenfreitas@usp.br
About this study
Official title: 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.
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.
- Conditions
- Aging Disorder, Obesity, Inflammation
- Being tested
- Multicomponent Training
- Keywords
- anabolic resistance, obesity, inflammation, physical exercise
- Medical subject headings
- Obesity, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Multicomponent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Changes in muscle quality
Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention
Measured: 12 weeks
Secondary outcomes (9)
Changes in muscle function
Evaluate the muscle function trough the load test pre and post intervention
Measured: 12 weeks
Changes in metabolic parameters - fasting blood glucose
Changes in fasting blood glucose samples in pre and post intervention
Measured: 12 weeks
Changes in metabolic parameters - insulin sensitivity
Changes in insulin sensitivity, estimated through HOMA-IR pre and post intervention
Measured: 12 weeks
Changes in muscle remodeling peptides
Changes in PNPLA3 and PNP3 in blood samples in pre and post intervention
Measured: 12 weeks
Body composition changes
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Measured: 12 weeks
Changes of physical performance
Physical performance changes, evaluated through physical tests.
Measured: 12 weeks
Changes in blood myostatin
Changes in blood myostatin levels pre and post intervention
Measured: 12 weeks
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry
Measured: 12 weeks
Changes in metabolic parameters - lipid profile
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C de Freitas, PhD, Principal investigator, University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552677
- Sponsor's protocol ID
- Exercise_Inflammation
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;34(2):183-195. doi: 10.1123/japa.2024-0341. Print 2026 Apr 1.
PubMed 40858281
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multicomponent Training on Inflammation Parameters in Correlation With Muscle Quality and Function in Elderly Obese Woman
- ClinicalTrials.gov ID
- NCT05552677
- Acronym / sponsor ID
- Exercise_Inflammation
- Conditions
- Aging Disorder, Obesity, Inflammation
- Keywords
- anabolic resistance, obesity, inflammation, physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | No intervention | –Patients will recieve no intervention for the period of 12 weeks |
| Exercise Group (EG) | Experimental | Other: Multicomponent TrainingPatients will undergo a 12 week multicomponent training program |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 30 and 40kg/m²;
Key exclusion criteria (11 listed)
- alcoholics
- smokers
- diseases that prevents the practice of physical activity
- medical impediment to the practice of physical exercise throughout the study
- infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent TrainingParticipants 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 | Other | Exercise Group (EG) |
Primary outcome
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
Changes in muscle quality
Time frame: 12 weeks
Evaluate the quantity of intramuscular fat deposits trough ultrasound pre and post intervention
9 secondary outcomes
Changes in muscle function
Time frame: 12 weeks
Changes in metabolic parameters - fasting blood glucose
Time frame: 12 weeks
Changes in metabolic parameters - insulin sensitivity
Time frame: 12 weeks
Changes in muscle remodeling peptides
Time frame: 12 weeks
Body composition changes
Time frame: 12 weeks
Changes of physical performance
Time frame: 12 weeks
Changes in blood myostatin
Time frame: 12 weeks
Indirect calorimetry assessment
Time frame: 12 weeks
Changes in metabolic parameters - lipid profile
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 40858281Travieso 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;34(2):183-195. doi: 10.1123/japa.2024-0341. Print 2026 Apr 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen C de Freitas, PhD principal investigator
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Training in people with Aging Disorder and Obesity, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia G Travieso, Specialist (16988084179, sofia.travieso@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inflamatory markers (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.