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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381976
Other study ID # UEL09167-2/2015
Secondary ID
Status Completed
Phase N/A
First received December 18, 2017
Last updated December 21, 2017
Start date March 2, 2015
Est. completion date July 24, 2015

Study information

Verified date December 2017
Source Universidade Estadual de Londrina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compared different frequency low-volume resistance training (RT) on total, android, gynoid and trunk body fat in obese older women


Description:

The aim of this study was to compare the effect of resistance training with different frequencies on total, android, gynoid and trunk body fat in obese older women. Recruitment was carried out through newspaper and radio advertisements, and home delivery flyers in residential neighborhoods. All participants completed health history and physical activity questionnaires, and met the following inclusion criteria: 60 years of age or older, relative body fat ≥ 32 assessed by whole body dual-energy X-ray absorptiometry (DXA), physically independent, free from cardiac or orthopedic dysfunction that would have precluded them from performing the tests or the training program associated with the study, not receiving hormonal replacement therapy, and not performing physical exercise more than once a week in the six months preceding the beginning of the investigation.Written informed consent was obtained from all participants after a detailed description of study procedures was provided. This study was conducted in accordance with the Declaration of Helsinki and approved by the local Ethics Research Committee, and was carried out over a period of 16 weeks, with 12 weeks dedicated to the resistance training program, and 4 weeks directed to testing. Anthropometric, body composition, and dietary intake measurements were performed during weeks 1-2, and 15-16. A supervised progressive resistance training was performed between weeks 3-14. The control group did not perform any type of organized physical exercise during the study period. Supervised resistance training was performed during the 12 weeks of training. All participants were individually supervised by physical education professionals throughout each training session to ensure that the study's training protocol was followed and to ensure subject safety. The group 2X performed the program twice a week (Tuesdays and Thursdays), while group 3X performed three sessions a week (Mondays, Wednesdays, and Fridays). The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date July 24, 2015
Est. primary completion date July 6, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 60 years of age or older;

- relative body fat = 32 assessed by whole body dual-energy X-ray absorptiometry (DXA);

- physically independent;

- free from cardiac or orthopedic dysfunction that would have precluded them from performing the tests or the training program associated with the study;

- not receiving hormonal replacement therapy;

- not performing physical exercise more than once a week in the six months preceding the beginning of the investigation.

Exclusion Criteria:

• All subjects not participating in 85% of the total sessions of training or withdrawl

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention 2X/week (G2X)
Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.
Intervention 3X/week (G3X)
Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual de Londrina

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body composition Whole-body dual-energy X-ray absorptiometry (DXA) scans (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) were used to assess total body fat, trunk fat, gynoid fat and android fat. Prior to scanning, participants were instructed to remove all objects containing metal. Scans were performed with the subjects lying in the supine position along the table's longitudinal centerline axis. Feet were taped together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. Both calibration and analysis were carried out by a skilled laboratory technician. Equipment calibration followed the manufacturer's recommendations. The software generated standard lines that set apart the limbs from the trunk and head. These lines were adjusted by the same technician using specific anatomical points determined by the manufacturer. The results are presented in kilograms (kg) baseline and 12 weeks
Primary Change in fat z-score A composite z-score, was calculated using the following formula: (total body fat z-score) + (gynoid body fat z-score) + (android fat z-score) / 3. Z-scores were obtained from the DXA using standard software. baseline and 12 weeks
Secondary Changes in Anthropometry Parameters Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale (Balmak, Laboratory Equipment Labstore, Curitiba, Paraná, Brazil), with the participants wearing light workout clothing and no shoes. Height was measured with a stadiometer attached to the scale to the nearest 0.1 cm, with subjects standing without shoes. These parameter will be combined to report body mass index that will be calculate as body mass in kilograms divided by the square of height in meters. baseline and 12 weeks
Secondary Changes in Dietary intake Participants were instructed by a dietitian to complete a food record on three nonconsecutive days (two week days and one weekend day) pre- and post-intervention. Participants were given specific instructions regarding the recording of portion sizes and quantities to identify all food and fluid intake, in addition to viewing food models in order to enhance precision. The amount of protein, carbohydrate, and lipid were calculated using nutrition analysis software (Avanutri Processor Nutrition Software, Rio de Janeiro, Brazil; Version 3.1.4). The sum of the three macronutrients will be presented by total energy intake which will be expressed per kcal/kg per day. baseline and 12 weeks
Secondary Changes in Total Strength Maximal dynamic strength was evaluated using the one repetition maximum (1RM) test assessed in the chest press, knee extension, and preacher curl exercises, performed in this exact order. Testing for each exercise was preceded by a warmup set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warmup was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load and were given three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the final load lifted in which the subject was able to complete only one single maximal execution. Total strength was determined by the sum of the 3 exercises, expressed in kg. baseline and 12 weeks
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