ObesityNCT03381976
Body Fat and Frequency of Resistance Training
A study testing Intervention 2X/week (G2X) and Intervention 3X/week (G3X) in people with Obesity, run by Universidade Estadual de Londrina.
Trial summary
This study compared different frequency low-volume resistance training (RT) on total, android, gynoid and trunk body fat in obese older women 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
- Obesity
- What is being tested?
- Intervention 2X/week (G2X) and Intervention 3X/week (G3X)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 24 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- 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.
Who cannot join
- All subjects not participating in 85% of the total sessions of training or withdrawl
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Intervention 2X/week (G2X), Intervention 3X/week (G3X)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 2X/week (G2X)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 2X/week (G2X) | Active comparator | This group performed resistance training twice a week (Tuesdays and Thursdays) Receives: Other: Intervention 2X/week (G2X) |
| Intervention 3X/week (G3X) | Active comparator | This group performed resistance training three sessions a week (Mondays, Wednesdays, and Fridays). Receives: Other: Intervention 3X/week (G3X) |
| Control group (GC) | No intervention | This group did not perform any type of organized physical exercise during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Secondary outcomes (3)
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start2 Mar 2015
- Primary completion6 Jul 2015
- Study completion24 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crisieli Maria Tomeleri, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381976
- Sponsor's protocol ID
- UEL09167-2/2015
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Frequency Low-volume Resistance Training on Body Fat in Obese Older: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03381976
- Acronym / sponsor ID
- UEL09167-2/2015
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 6 Jul 2015 (actual)
- Study completion
- 24 Jul 2015 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared different frequency low-volume resistance training (RT) on total, android, gynoid and trunk body fat in obese older women
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 2X/week (G2X) | Active comparator | Other: Intervention 2X/week (G2X)This group performed resistance training twice a week (Tuesdays and Thursdays) |
| Intervention 3X/week (G3X) | Active comparator | Other: Intervention 3X/week (G3X)This group performed resistance training three sessions a week (Mondays, Wednesdays, and Fridays). |
| Control group (GC) | No intervention | –This group did not perform any type of organized physical exercise during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- All subjects not participating in 85% of the total sessions of training or withdrawl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention 2X/week (G2X) |
| 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. | Other | Intervention 3X/week (G3X) |
Primary outcome
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)
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.
3 secondary outcomes
Changes in Anthropometry Parameters
Time frame: baseline and 12 weeks
Changes in Dietary intake
Time frame: baseline and 12 weeks
Changes in Total Strength
Time frame: baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 2X/week (G2X) and Intervention 3X/week (G3X) in people with Obesity, run by Universidade Estadual de Londrina.
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 6 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: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: baseline and 12 weeks). 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?
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 22 Dec 2017.