Clinical trial NCT06621368: Effect of Two Years of Resistance Training on Health Status in Postmenopausal Women: Longitudinal Study Active Aging.
Official title: Effect of Two Years of Resistance Training on Muscular Strength, Body Composition, Functional Fitness, Metabolic Biomarkers, Cognition, and Cardiac Parameters in Postmenopausal Women: Longitudinal Study Active Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: bone mineral density
health´s women
skeletal muscle mass
motor performance
strength training
metabolism
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 60 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Body Fat
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Muscle mass
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Cardiac function
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: MoCA
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Stroop test
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Set shifting
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Verbal fluency tasks
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Depressive symptoms
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Anxiety symptoms
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
measure: Bone
timeFrame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: State University of Londrina
state: Paraná
Study officials:
References:
citation: 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.
citation: 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.