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AgingNCT06621368

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

A study testing Exercise in people with Aging, run by Universidade Estadual de Londrina at 1 site in Brazil.

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

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. Read more about this study

Who is it for?
Ages 60 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBrazil
Study dates
23 Nov 2023to 23 Nov 2026
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

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

Brazil1 site, 1 recruiting
  • State University of Londrina

    Londrina, Paraná, 86057-970

    Edílson S Cyrino, PhD, 55 43 9139-4509, edilsoncyrino@gmail.com

    Recruiting

Other trials in Brazil

About this study

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

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
Being tested
Exercise, Control-no treatment
Keywords
bone mineral density, health´s women, skeletal muscle mass, motor performance, strength training, metabolism

What participants receive

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

  • ExerciseOther

    Also called Resistance traning

    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.

  • Control-no treatmentOther

    Participants will maintain their daily activities.

Study groups in NCT06621368
Study groupRoleWhat they receive
control group = participants maintained their usual activities normallyNo interventionParticipants maintained their ususal activities normally
exercise group = participants performed two years of strength trainingExperimentalParticipants will performed two years of strength training
Receives: Other: Exercise; Other: Control-no treatment

What is being measured

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

  1. 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.

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

  2. 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.

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

Secondary outcomes (9)
  1. Cardiovascular risk factors

    HDL-c (mg/dL), LDL-c (mg/dL), Total cholesterol (mg/dL), Glucose (mg/dL), triglycerides(mg/dL), C-reactive protein (mg/dL)

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

  2. Cardiac function

    Echocardiography exams were performed accord- ing to current guidelines [18], at baseline and the end of the investigation, by an experienced echocardi- ographer blinded to patient status and group assign- ment, using a Philips ultrasound machine, model iE33 (Philips Medical Solutions, Noord Brabant, The Netherlands), equipped with an S5-1 and X5-1 transducer. According to current recommendations, cardiac chamber dimensions, volumes, and left ven- tricular mass were measured. Mitral inflow velocities were assessed using a pulsed-wave Doppler in the apical four-chamber view, with the sample volume placed between the tips of the mitral leaflets; veloci- ties were recorded at end-expiration. Tissue Doppler velocities were acquired at end-expiration, in the api- cal four-chamber view, with the sample positioned at the septal and lateral mitral annulus for determination of systolic (S'), early diastolic (E'), and late diastolic (A') velocities.

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

  3. MoCA

    The Brazilian version ofthe Montreal Cognitive Assessment (MoCA) was used to analyze the global cognitive function. The MoCA is a screening tool composed of 12 individually punctuated tasks grouped into eight cognitive domains. The total score ranges from 0 to 30 (higher values reflect better cognition). Cognitive domains and their respective punctuations are as follows: short-term memory (delayed recall, 5 points); visuospatial abilities (cube drawing, 1 point, clock drawing, 3 points); executive function (trail making test, 1 point; phonemic verbal fluency, 1 point; verbal abstraction, 2 points); attention, concentration, andwork- ing memory (cancelation, 1 point; subtraction, 3 points; digit span, 2 points); language (naming, 3 points; sentence repetition, 2 points); and orientation to time (3 points) and space (3 points).

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

  4. Stroop test

    The Stroop test version used in the present study consisted of 36 tasks. In every trial, one cue appeared at the top part of the screen and the bottom two response options, one matched and one mismatched. Participants had to press the directional button (\< or \>) corresponding to the position ofthe correct response as quickly and accurately as possible. The test consisted of three stages with 12 trials each: (I-congruent) an inked rect- angle (green, black, red, or blue) appeared, and participants had to choose the response corresponding to the ink name; (II- neutral) a color name (green, black, red, or blue) appeared in white ink, and participants had to choose the option corresponding to the color name; (III-incongruent) a color name appeared at the top of the screen in a different ink color (e.g., the word black in green ink). The participants had to respond to the ink color, not the color name (e.g., green in this example).

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

  5. Set shifting

    The Trail Making Tests parts A and B were used to assess set shifting. Part A assesses the psychomotor speed and requires the participant to draw lines that connect encircled numbers sequentially, such as drawing a line from 1 to 2, 2 to 3, 3 to 4, and so on. Part B consists ofencircled numbers and letters. Participants were instructed to draw a line as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they completed the task. We recorded the time (in seconds) they took to complete each task. We calculated the difference between part B and part A completion times to index set shifting. Smaller difference scores indicate better set shifting.

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

  6. Verbal fluency tasks

    Participants were asked to say asmany words as possible within 60 s (31). In the first trial, par- ticipants had to produce words starting with the letter "F" (letter fluency) and produce the name of animals (category fluency). The final score refers to the number ofwords correctly spoken in 60 s.

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

  7. Depressive symptoms

    The 15-item Geriatric Depres- sion Scale (GDS-15): The GDS-15 comprises 15 dichotomic items (yes or not) concerning different characteristics of geriatric depression as cognitive decline and somatic symptoms, with the final score ranging from 0 to 15, where the higher scores are worse.

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

  8. Anxiety symptoms

    Beck Anxiety Inventory (BAI): The BAI comprises 21 items (statements) about different anxiety symptoms with a 4-point Likert scale, with the final score ranging from 0 to 63, where the higher scores are worse.

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

  9. Bone

    Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total and regional bone mineral density (cm/m²). 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.

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

Timeline

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

  1. First posted1 Oct 2024
  2. Study start23 Nov 2023
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion23 Nov 2026 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621368
Sponsor's protocol ID
GEPEMENE 2024b
Status last verified
Sep 2024
First submitted
12 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29751507
  • 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.

    PubMed 27897417

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Aging, run by Universidade Estadual de Londrina at 1 site in Brazil.

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 5 inclusion and 1 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Fat (time frame: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06621368, which also lists 2 linked publications.

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 1 Oct 2024.

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