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AgingRETOPONCT06367296

Resistance Exercise Training in the Older Population With Obesity

A study testing Prolonged resistance exercise training in people with Aging and Obesity, run by Universidad de La Frontera at 2 sites in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 79 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aging, Obesity
What is being tested?
Prolonged resistance exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesChile
Study dates
1 Jul 2024to 1 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 79 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolás Vidal-Seguel, MSc contact

998595445

nicolasenrique.vidal@ufrontera.cl

GABRIEL MARZUCA, MSc, PhD contact

996343630

gabriel.marzuca@ufrontera.cl

Chile2 sites, 2 recruiting
  • Gabriel Marzuca

    Temuco, Araucania, 4780000

    GABRIEL MARZUCA, 996343630, gabriel.marzuca@ufrontera.cl

    Recruiting
  • Universidad de La Frontera

    Temuco, IX Región de La Araucanía, 4780000

    Nicolás Vidal-Seguel, MSc, 998595445, nicolasenrique.vidal@ufrontera.cl

    GABRIEL MARZUCA, MSc, PhD, 996343630, gabriel.marzuca@ufrontera.cl

    Not yet recruiting

Other trials in Chile

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Aging, Obesity
Being tested
Prolonged resistance exercise training
Keywords
Strength training, Malnutrition due to excess, Biochemical markers, Clinical anatomy
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged resistance exercise trainingOther

    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.

Study groups in NCT06367296
Study groupRoleWhat they receive
Normal WeightExperimentalAll volunteers Normal Weight: BMI=18.5 kg/m2 to 24.9 kg/m2 and % fat <25.9%, n=16
Receives: Other: Prolonged resistance exercise training
ObeseExperimentalAll volunteers Obesity: BMI= 30.0 kg/m2 to 39.9 kg/m2 m2 and % fat > 32%, n=16.
Receives: Other: Prolonged resistance exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise 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

    Measured: Before, and after 12 weeks of training

Secondary outcomes (14)
  1. Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise 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.

    Measured: Before, and after 12 weeks of training

  2. Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise 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

    Measured: Before, and after 12 weeks of training

  3. Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise 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.

    Measured: Before, and after 12 weeks of training

  4. Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training

    Measurement of physical performance via SPPB

    Measured: Before, and after 12 weeks of training

  5. Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training

    Maximal strength assessment via 1RM testing of leg press, leg extension, leg flexion, chest press and triceps extension

    Measured: Before, and after 12 weeks of training

  6. Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training

    Maximal strength assessment via 1RM testing of JAMAR(R) handheld dynamometer.

    Measured: Before, and after 12 weeks of training

  7. Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training.

    The maximum voluntary isometric knee extension force (Newton) evaluated in both lower limbs (always maintaining randomness in the limbs).

    Measured: Before, and after 12 weeks of training

  8. Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training.

    The muscle power of the lower limbs (Watt) evaluated by equation STS Men Power.

    Measured: Before, and after 12 weeks of training

  9. Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training.

    The immune response evaluated by TNFa,IL-1, IL-6, IL-8 (pg/ml)

    Measured: Before, and after 12 weeks of training

  10. Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training.

    The NETosis (%) evaluated with live cell imaging in donated neutrophils cultured with serum from the participants for 30 h.

    Measured: Before, and after 12 weeks of training

  11. Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training.

    The Whole Body lean mass (Kg) through TANITA MC 980U PLUS

    Measured: Before, and after 12 weeks of training

  12. Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training.

    The Whole Body fat mass (Kg) through TANITA MC 980U PLUS

    Measured: Before, and after 12 weeks of training

  13. Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training.

    The physical activity level evaluated by International Physical Activity Questionnaire, short version. Classifying the level of physical activity as low, moderate or high.

    Measured: Before, and after 12 weeks of training

  14. Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise 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.

    Measured: Before, and after 12 weeks of training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start1 Jul 2024
  3. Primary completion28 Jan 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

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
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06367296
Sponsor's protocol ID
RETOPO2024
Acronym
RETOPO
Status last verified
Jan 2025
First submitted
2 Apr 2024
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prolonged resistance exercise training in people with Aging and Obesity, run by Universidad de La Frontera at 2 sites in Chile.

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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolás Vidal-Seguel, MSc (998595445, nicolasenrique.vidal@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training (time frame: Before, and after 12 weeks of training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jan 2025.

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