Resistance Exercise Training in the Older Population With Obesity

NCT ID: NCT06367296

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-06-01

Brief 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. 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Normal Weight

All volunteers Normal Weight: BMI=18.5 kg/m2 to 24.9 kg/m2 and % fat \<25.9%, n=16

Group Type: EXPERIMENTAL

Prolonged resistance exercise training

Intervention Type: OTHER

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.

Obese

All volunteers Obesity: BMI= 30.0 kg/m2 to 39.9 kg/m2 m2 and % fat \> 32%, n=16.

Group Type: EXPERIMENTAL

Prolonged resistance exercise training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Vidal-Seguel,

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GABRIEL MARZUCA, Msc, PhD

Role: STUDY_DIRECTOR

Universidad de La Frontera. Temuco, Chile

Locations

Universidad de La Frontera

Temuco, IX Región de La Araucanía, Chile

Site Status: NOT_YET_RECRUITING

Gabriel Marzuca

Temuco, Región de la Araucanía, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Nicolás Vidal-Seguel, MSc

Role: CONTACT

nicolasenrique.vidal@ufrontera.cl

998595445

GABRIEL MARZUCA, MSc, PhD

Role: CONTACT

gabriel.marzuca@ufrontera.cl

996343630

Facility Contacts

Nicolás Vidal-Seguel, MSc

Role: primary

nicolasenrique.vidal@ufrontera.cl

998595445

GABRIEL MARZUCA, MSc, PhD

Role: backup

gabriel.marzuca@ufrontera.cl

996343630

GABRIEL MARZUCA

Role: primary

gabriel.marzuca@ufrontera.cl

996343630

Other Identifiers

RETOPO2024

Identifier Type: -

Identifier Source: org_study_id