Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06160141 |
| Other study ID # |
GEPEMENE 2023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
December 20, 2019 |
Study information
| Verified date |
November 2023 |
| Source |
Universidade Estadual de Londrina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: This study aimed to determine the effect of 48 weeks of resistance training (RT) on
cardiac function in older women. Methods: Sixty-four older women (≥ 60 years), physically
independent, were selected for this study. Participants were randomized into a training group
(TG, n = 33) and a control group (CG, n = 31). The RT program was conducted over 48 weeks,
three sessions a week, on nonconsecutive days, in the morning hours. Participants performed
eight exercises for the whole body (chest press, horizontal leg press, seated row, leg
extension, triceps pushdown, lying leg curl, preacher curl, seated calf raise) in three sets
of 8-12 repetitions. The echocardiography was performed according to current guidelines
before and after 48 weeks by an experienced echocardiographer blinded to patient status and
group assignment. One-repetition maximum (1-RM) tests were used to analyze muscular strength.
Glusoce, lipid profile, and C-reactive protein were measured. DEXA was used to measure body
fat and muscle mass.
Description:
Echocardiography exams were performed according to current guidelines, at baseline and the
end of the study, by an experienced echocardiographer blinded to patient status and group
assignment in a Philips ultrasound machine, model iE33 (Philips Medical Solutions, Noord
Brabant, The Netherlands), equipped with S5-1 and X5-1 transducer. According to current
recommendations, cardiac chamber dimensions, volumes, and left ventricular mass were
measured. Mitral inflow velocities were assessed using pulsed-wave Doppler in the apical
four-chamber view, with the sample volume placed between the tips of the mitral leaflets;
velocities were recorded at end-expiration. Tissue Doppler velocities were acquired at
end-expiration, in the apical 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. Pulsed wave Doppler velocities at the upper right pulmonary vein
were also recorded. For all parameters, the average of three consecutive heartbeats was
recorded.
Dietary intake - The 24-hour dietary recall method was used to analyze the participants'
habitual intake throughout the study. Assessments were performed on three non-consecutive
days of the week, in the first and last two weeks of each intervention phase. During the
interviews, a photographic manual of food portion size was presented to the participants to
improve the quality of food intake reports. Homemade measurements of the nutritional values
of food were converted into grams and milliliters by the online software Virtual Nutri Plus
(Keeple®, Rio de Janeiro, RJ, Brazil) for diet analysis. All foods not found in the program
database were added to food tables.
Muscular strength Maximal dynamic strength was evaluated using one-repetition maximum (1RM)
tests on the chest press, leg extension, and preacher curl exercises (Ipiranga Fitness,
Presidente Prudente, SP, Brazil), respectively, following standard procedures 17,18. Three
1RM testing sessions were performed in the morning, separated by 48 h intervals. In each
session, participants completed a warm-up of 10-15 repetitions before each exercise with
approximately 50% of the estimated load to the first attempt, followed by three maximal
attempts. For the first day of testing, the first selected load was based on the researchers'
experience and perception of the difficulty (effort) with which participants performed the
warm-up. If the first attempt was completed, the load was added for the subsequent attempts
(3-10% of the previous effort). If an attempt was unsuccessful, load was removed in the same
proportion. The rest period was three to five minutes between attempts and five minutes
between exercises. The load for the first attempt in the second and third sessions was the
maximal obtained in the previous session. Participants were encouraged to perform two
repetitions with the selected load during each effort in the three exercises. The 1RM was
recorded as the heaviest load lifted in which participants could complete only one voluntary
muscle action among the three sessions. In addition, a total muscular strength score was
calculated as the sum of the highest scores in each of the three exercises. Two experienced
researchers supervised each exercise during testing sessions to standardize technique
reliability and ensure the safety of participants.
Body composition. Dual-energy X-ray absorptiometry exams were performed in a Lunar Prodigy
device, model NRL 41990 (General Electric, Madison, USA), to determine the total, regional
lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and
android fat masses. 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. The same technician adjusted these lines using
specific anatomical points determined by the manufacturer and performed all analyses during
the intervention. A predictive equation estimated total-body skeletal muscle mass from ALST.
Functional fitness tests - Four motor tests determined functional fitness: gait speed (4-m
usual walking speed), walking agility, 30-s chair stand, and 6-min walk (6MWT). Three
evaluators used stopwatches (KIKOS, São Paulo, SP, Brazil) to measure participants' time
walking a 4-m usual walking speed. Adhesive tapes on the floor demarcated this distance with
additional 2-m patches before and after the 4-m main patch. Participants walked 8-m, but only
the time spent walking the middle 4-m was timed to the nearest 0.01 s. Participants completed
three attempts, with the mean used for analysis. For the walking agility test, participants
were seated on a chair supported by a wall, with their back in contact with the backrest,
feet fully supported on the floor, and hands rested on the thighs. Participants were
requested to stand up, walk around a cone at a distance of 2.44 m in front of the chair,
return to the chair and sit down. Participants were instructed to complete the path as
quickly as possible without running. Time was recorded to the nearest 0.01 s with a stopwatch
from the initial movement to rise from the chair until returning to sit down again.
Participants completed three trials, with the best one recorded for analysis. For the 30-s
chair stand test, participants were seated on a chair supported by a wall, with their back in
contact with the backrest, feet fully supported on the floor, and hands crossed to rest on
their opposite shoulders. Participants performed the maximum sit-to-stand repetitions
possible within 30 seconds. An evaluator recorded the time and counted the number of
completed repetitions performed. For the 6MWT, each participant was instructed to walk as far
as possible, without running, around a rectangular path (4.6 x 18.4 m, total perimeter: 46.0
m) marked with ribbons and cones on the floor for 6-min. An evaluator timed the test time,
counted the number of laps, and calculated the total distance covered with an accuracy of one
meter. The 6MWT assesses walking ability and endurance.
Metabolic biomarkers - The blood sample (venous) was collected in a tube containing a
dipotassium ethylenediaminetetraacetic acid (12 ml, vacuum-sealed system; Vacutainer,
England) between 7:00 and 9:00 a.m. by a trained laboratory technician after an overnight
fast of at least 12 h. Participants rested in a seated position for at least five minutes
before withdrawing 5 ml of blood from a prominent superficial vein in the antecubital space.
All samples were centrifuged at 3,000 rpm for 15 min, and plasma or serum aliquots were
stored at -80° C until assayed. As determined in human plasma, inter- and intra-assay
coefficients of variation were < 10%. Measurements of serum levels of high-sensitivity
C-reactive protein, glucose, total cholesterol (TC), high-density lipoprotein cholesterol
(HDL-c), and triglycerides (TG) were determined by standard methods in a specialized
laboratory at University Hospital. The low-density lipoprotein cholesterol (LDL-c) was
calculated using the following equation: LDL-c = TC - (HDL-c + TG/5). The analyses were
performed using a Dimension RxL Max biochemical auto-analyzer system (Siemens Dade Behring,
Erlangen, Germany) according to established methods in the literature consistent with the
manufacturer's protocol.
Resistance training program - The RT program was performed over 48 weeks, three times per
week (Mondays, Wednesdays, and Fridays), during the morning, in the University fitness
facility. Participants were personally supervised by Physical Education professionals (1-2
supervisors per exercise) with substantial RT experience to ensure consistent and safe
exercise performance. Throughout the intervention period, the RT program was carried out on
machines and free weights (Ipiranga Fitness, Presidente Prudente, SP, Brasil).
Participants performed four exercises for the trunk and upper limbs (chest press, seated row,
triceps pushdown, preacher curl) and four exercises for the lower limbs (horizontal leg
press, leg extension, lying leg curl, seated calf raise) in three sets of 8-12 repetitions.
The participants were instructed to inhale during the eccentric phase and exhale during the
concentric phase while maintaining a constant movement velocity at a ratio of approximately
1:2 s (concentric and eccentric muscle actions, respectively). Rest intervals were 1-2 and
2-3 min between sets and exercises. The training load was individually adjusted for each
exercise weekly, according to the number of repetitions performed during the last training
session, to ensure that the subjects kept performing at the ideal intensity for the
repetition zone. In these situations, training loads were increased by 2-5% for upper-limb
exercises and 5-10% for lower-limb exercises.
