NCT06367296

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

April 2, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

Strength trainingMalnutrition due to excessBiochemical markersClinical anatomy

Outcome Measures

Primary Outcomes (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

    Before, and after 12 weeks of training

Secondary Outcomes (14)

  • Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training

    Before, and after 12 weeks of training

  • Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training

    Before, and after 12 weeks of training

  • Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training

    Before, and after 12 weeks of training

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

    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

    Before, and after 12 weeks of training

  • +9 more secondary outcomes

Study Arms (2)

Normal Weight

EXPERIMENTAL

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

Obese

EXPERIMENTAL

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

Other: Prolonged resistance exercise training

Interventions

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.

Normal WeightObese

Eligibility Criteria

Age60 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de La Frontera

Temuco, IX Región de La Araucanía, 4780000, Chile

NOT YET RECRUITING

Gabriel Marzuca

Temuco, Región de la Araucanía, 4780000, Chile

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GABRIEL MARZUCA, Msc, PhD

    Universidad de La Frontera. Temuco, Chile

    STUDY DIRECTOR

Central Study Contacts

Nicolás Vidal-Seguel, MSc

CONTACT

GABRIEL MARZUCA, MSc, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 16, 2024

Study Start

July 1, 2024

Primary Completion

January 28, 2025

Study Completion

June 1, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations