Resistance Exercise Training in the Older Population With Obesity (RETOPO)

January 22, 2025 updated by: Nicolas Vidal-Seguel,, Universidad de La Frontera

Effects of a Resistance Exercise Training Program on Skeletal Muscle Quality, Immune Response and Physical Performance in Normal Weight Versus Obesity Older Women

Background:

Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.

Hypothesis:

A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.

Goals:

The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.

Methodology:

The present clinical trial will consider 2 groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat <25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % >32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.

Hypothesis:

A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.

Goals:

The primary aim of this study is evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.

Specific goals:

To evaluate the effects of a 12-week resistance exercise training program in elderly women between 60 and 79 years of age with obesity, in comparison to older people with normal weight of the same age range on parameters of:

  • Muscle architecture (muscle thickness, pennation angle and fascicle length) and muscle quality functionalities (power and strength).
  • Immune response through inflammatory cytokines: Tumor necrosis factor a (TNFa) interleukin-1 (IL-1), IL-6, IL-8 and induction of neutrophil extracellular traps (NETosis).
  • Physical performance (SPPB), Body composition (BIA) and quality of life (SF-36).

Methodology:

The present clinical trial will consider 2 study groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat <25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % >32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated.

Study parameters/endpoints

  • The main study endpoint is the decrease in echointensity as a marker of muscle quality, evaluated through ultrasonography in the quadriceps muscles of the lower limbs of participants subjected to 12 weeks of resistance training.
  • Secondary endpoints include: Muscle architecture parameter (morphological aspects of muscle quality); muscle thickness, pennation angle and fascicle length; Functional parameters of muscle quality, maximum voluntary isometric strength of knee extensors and lower limb power; Immune response in blood (TNFa, IL-1, IL-6, IL-8 and NETosis); Physical performance (SPPB), evaluation of maximum strength (1RM) and handgrip strength; Body composition (fat mass and total muscle mass and for each lower limb) and anthropometry (waist - hip, thigh and calf circumference, leg length and knee height); And Level of physical activity (IPAQ) and Quality of Life (SF-36).
  • Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, insulin, HOMA index, blood pressure, heart rate and perception of effort using the Borg scale.

Expected results:

The effect of resistance exercise training on muscle quality in normal-weight versus obese older women is still unclear. The present research project aims to demonstrate the effectiveness of this training modality in improving muscle quality parameters, as well as measures of immune response and physical performance in older women. However, the investigators believe that the impact will be greater in women with obesity, as they present greater baseline alterations compared to older normal weight women. The possible findings will define the scientific-practical foundations for the prescription of physical training in older women with obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Chile
    • Araucanía
      • Temuco, Araucanía, Chile, 4780000
    • IX Región De La Araucanía

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Older women between 60 and 79 years old who live in the community, that is, they do not live in nursing homes or similar.
  • Older people with normal weight (BMI=18.5 to 24.9 kg/m2 and % fat <25.9) and those with obesity (BMI= 30 to 39.9 Kg/m2 and % fat > 32).
  • Cognitive ability to follow verbal orders.

Exclusion Criteria:

  • Neuromuscular or mobility disorders that do not allow resistance training to be carried out safely (debilitating arthritis, spasticity/rigidity, neurological disorders and paralysis).
  • Use of nutritional supplementation that can regulate skeletal muscle (leucine, glutamine, casein, whey-protein, fatty acids and creatine).
  • Untreated and/or uncontrolled chronic diseases.
  • Have carried out a training program with resistance exercises in the last 6 months.

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: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Weight
All volunteers Normal Weight: BMI=18.5 kg/m2 to 24.9 kg/m2 and % fat <25.9%, n=16
Other: Prolonged resistance exercise training
Training with resistance exercises for upper and lower limbs will be carried out 3 times a week (Monday, Wednesday and Friday) for 12 weeks for all participants. The training will follow the guidelines of the American College of Sports Medicine ("American College of Sports Medicine Position Stand. Progression Models in Resistance Training for Healthy Adults," 2009) and will consist of a 5-minute cardiovascular warm-up on a cycle ergometer, followed by weight training. Resistance training will be carried out with exercise machines: 5 sets of leg press, leg extension and leg flexion for lower limbs and 3 sets of chest press and triceps extension for upper limbs. Subsequently, the participants will perform global flexibility exercises for 5 minutes to return to calm.
Experimental: Obese
All volunteers Obesity: BMI= 30.0 kg/m2 to 39.9 kg/m2 m2 and % fat > 32%, n=16.
Other: Prolonged resistance exercise training
Training with resistance exercises for upper and lower limbs will be carried out 3 times a week (Monday, Wednesday and Friday) for 12 weeks for all participants. The training will follow the guidelines of the American College of Sports Medicine ("American College of Sports Medicine Position Stand. Progression Models in Resistance Training for Healthy Adults," 2009) and will consist of a 5-minute cardiovascular warm-up on a cycle ergometer, followed by weight training. Resistance training will be carried out with exercise machines: 5 sets of leg press, leg extension and leg flexion for lower limbs and 3 sets of chest press and triceps extension for upper limbs. Subsequently, the participants will perform global flexibility exercises for 5 minutes to return to calm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Intramuscular adipose tissue infiltration evaluated by echointensity (Pixel Intensity 0 to 255) in the rectus femoris and vastus intermedius muscles of both lower limbs
Before, and after 12 weeks of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Muscle thickness (centimeters) evaluated in the rectus femoris and vastus intermedius muscles of both lower limbs. The muscle thickness evaluated as the distance between the deep and superficial fascia.
Before, and after 12 weeks of training
Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Pennation angle (degree) evaluated in the rectus femoris and vastus intermedius muscles of both lower limbs. The pennation angle evaluated as the angle between the fascicle and the deep fascia. The average of three measurements will be calculated
Before, and after 12 weeks of training
Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Fascicle length (centimeters) evaluated in the rectus femoris and vastus intermedius muscles of both lower limbs. Fascicle length = sin(y +90º) × MT/ sin(180º-(y +180º- PA)), where "y" is the angle between the superficial and deep facia, while PA is the pennation angle, while MT is the Muscle thickness.
Before, and after 12 weeks of training
Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Measurement of physical performance via SPPB
Before, and after 12 weeks of training
Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Maximal strength assessment via 1RM testing of leg press, leg extension, leg flexion, chest press and triceps extension
Before, and after 12 weeks of training
Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training
Time Frame: Before, and after 12 weeks of training
Maximal strength assessment via 1RM testing of JAMAR(R) handheld dynamometer.
Before, and after 12 weeks of training
Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The maximum voluntary isometric knee extension force (Newton) evaluated in both lower limbs (always maintaining randomness in the limbs).
Before, and after 12 weeks of training
Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The muscle power of the lower limbs (Watt) evaluated by equation STS Men Power.
Before, and after 12 weeks of training
Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The immune response evaluated by TNFa,IL-1, IL-6, IL-8 (pg/ml)
Before, and after 12 weeks of training
Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The NETosis (%) evaluated with live cell imaging in donated neutrophils cultured with serum from the participants for 30 h.
Before, and after 12 weeks of training
Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The Whole Body lean mass (Kg) through TANITA MC 980U PLUS
Before, and after 12 weeks of training
Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The Whole Body fat mass (Kg) through TANITA MC 980U PLUS
Before, and after 12 weeks of training
Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The physical activity level evaluated by International Physical Activity Questionnaire, short version. Classifying the level of physical activity as low, moderate or high.
Before, and after 12 weeks of training
Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise training.
Time Frame: Before, and after 12 weeks of training
The Quality of Life level evaluated by SF-36 questionnaire. The score ranges from 0 to 100%, where a higher score High implies a better quality of life related to health.
Before, and after 12 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de La Frontera

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GABRIEL MARZUCA, Msc, PhD, Universidad de La Frontera. Temuco, Chile

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RETOPO2024

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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