Effect of Two Years of Resistance Training on Health Status in Postmenopausal Women: Longitudinal Study Active Aging.

NCT06621368 | Recruiting

• 1 other identifier: GEPEMENE 2024b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed.

Conditions

Aging

Keywords

bone mineral density; health´s women; skeletal muscle mass; motor performance; strength training; metabolism

Outcome Measures

Primary Outcomes (2)

• Body Fat

  Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

• Muscle mass

  Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

Secondary Outcomes (9)

• Cardiovascular risk factors

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

• Cardiac function

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

• MoCA

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

• Stroop test

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

• Set shifting

  from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

Study Arms (2)

control group = participants maintained their usual activities normally

NO INTERVENTION

Participants maintained their ususal activities normally

exercise group = participants performed two years of strength training

EXPERIMENTAL

Participants will performed two years of strength training

Other: Exercise; Other: Control-no treatment

Interventions

Exercise OTHER

the RT program will consist of eight exercises for different body segments, namely: vertical bench press, horizontal leg press, low row, leg extension, scott curl, leg curl, triceps pulley and seated calf raise. Every 12 weeks of training, the program will be restructured with changes in the order in which the exercises are performed, the number of sets, the number of repetitions or the training system in an attempt to avoid a supposed adaptive plateau. The protocols in each stage will follow the recommendations for prescribing RT for the elderly, aiming at improving strength and hypertrophy, namely: a combination of single-joint and multi-joint exercises (free weights and machines), slow or moderate execution speed (ratio 1:2 for concentric and eccentric muscle actions, respectively), one to three sets of multiple repetitions, 8-12 RM or 10-15 RM, with recovery intervals between sets of one to two minutes, and a training frequency of two to three weekly sessions, on alternate days.

Also known as: Resistance traning

exercise group = participants performed two years of strength training

Control-no treatment OTHER

Participants will maintain their daily activities.

exercise group = participants performed two years of strength training

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• physically independent;
• not have cardiovascular, musculoskeletal or metabolic limitations that prevent the practice of physical exercises or the execution of motor tests;
• not being on hormone replacement therapy;
• not being involved in physical exercise more than once a week, over the six months prior to the start of the study.

You may not qualify if:

• not participating in at least 85% of the training and not attending the assessments.

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

State University of Londrina

Londrina, Paraná, 86057-970, Brazil

RECRUITING

Related Publications (2)

• Nabuco HCG, Tomeleri CM, Sugihara Junior P, Fernandes RR, Cavalcante EF, Antunes M, Ribeiro AS, Teixeira DC, Silva AM, Sardinha LB, Cyrino ES. Effects of Whey Protein Supplementation Pre- or Post-Resistance Training on Muscle Mass, Muscular Strength, and Functional Capacity in Pre-Conditioned Older Women: A Randomized Clinical Trial. Nutrients. 2018 May 3;10(5):563. doi: 10.3390/nu10050563.

  PMID: 29751507 BACKGROUND

• Dos Santos L, Cyrino ES, Antunes M, Santos DA, Sardinha LB. Sarcopenia and physical independence in older adults: the independent and synergic role of muscle mass and muscle function. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):245-250. doi: 10.1002/jcsm.12160. Epub 2016 Nov 8.

  PMID: 27897417 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 1, 2024
• Study Start: November 23, 2023
• Primary Completion: December 20, 2025
• Study Completion (Estimated): November 23, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)