- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381976
Body Fat and Frequency of Resistance Training
December 21, 2017 updated by: Crisieli Maria Tomeleri, Universidade Estadual de Londrina
Effects of Different Frequency Low-volume Resistance Training on Body Fat in Obese Older: A Randomized Controlled Trial
This study compared different frequency low-volume resistance training (RT) on total, android, gynoid and trunk body fat in obese older women
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention 2X/week (G2X)
This group performed resistance training twice a week (Tuesdays and Thursdays)
|
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.
|
Active Comparator: Intervention 3X/week (G3X)
This group performed resistance training three sessions a week (Mondays, Wednesdays, and Fridays).
|
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.
|
No Intervention: Control group (GC)
This group did not perform any type of organized physical exercise during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition
Time Frame: baseline and 12 weeks
|
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
|
Change in fat z-score
Time Frame: baseline and 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Anthropometry Parameters
Time Frame: baseline and 12 weeks
|
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
|
Changes in Dietary intake
Time Frame: baseline and 12 weeks
|
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
|
Changes in Total Strength
Time Frame: baseline and 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2015
Primary Completion (Actual)
July 6, 2015
Study Completion (Actual)
July 24, 2015
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 21, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- UEL09167-2/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Intervention 2X/week (G2X)
-
Gary Van GuilderWestern Colorado University; Auckland University of TechnologyCompletedMetabolic Syndrome | Insulin Resistance | Endothelial Dysfunction | Atherogenic DyslipidemiaUnited States
-
George Fox UniversityRecruitingBlood Flow Restriction TrainingUnited States
-
NYU Langone HealthCompletedDiabetesUnited States
-
University of FloridaNational Institute on Aging (NIA)Recruiting
-
University of TwenteCompleted
-
Chinese University of Hong KongCompletedMild Cognitive ImpairmentHong Kong
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Sun Yat-sen UniversityNot yet recruiting
-
Barbara Ann Karmanos Cancer InstituteRecruitingCancer SurvivorsUnited States
-
McGill UniversityActive, not recruitingStress | Sleep | Depressive Symptoms | Anxiety Disorders and Symptoms | Affect | Non-suicidal Self-injury | Wellness, PsychologicalCanada