Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06160141
Study type Interventional
Source Universidade Estadual de Londrina
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date December 20, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1