SarcopeniaNCT02681744
Sarcopenia, Obesity, and Resistance Training
A study testing Resistance Training in people with Sarcopenia and Aging, run by University of Brasilia at 1 site in Brazil.
Trial summary
The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Aging, Obesity
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Aug 2016
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community older women (aged between 60 and 80 years).
Who cannot join
- individuals with any metallic implant or artificial pacemaker, who had undergone hip surgery, who were unable to walk without assistance and those affected by metabolic or endocrine disorders that affect the muscular system.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Educação Física
Brasília, Federal District, 70910900
Silvia G Neri, MSc, +556182055934, silvia_grn@hotmail.com
About this study
Official title: Effects of Resistance Training on Sarcopenic Obesity Index in Older Women: a RCT.
The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.
Read the detailed description
To examine the effects of resistance training on sarcopenic obesity in older women, a representative sample of older women from Brasília, Brazil (n>244 subjects), will be recruited and invited to undergo body composition measurement using dual-energy x-ray absorptiometry. Moreover, the Sarcopenic Obesity index and isokinetic strength evaluations will be performed. It will be a single-blind randomized, controlled 24-week clinical trial, in which experimental group will receive a progressive resistance training program, meanwhile control group will receive instructions to maintain their lifestyle habits. Randomization will be conducted by computer-generated list in blocks of 10. Additionally, body composition, strength assessment, and sarcopenic index will collected and compared after the intervention period.
- Conditions
- Sarcopenia, Aging, Obesity
- Being tested
- Resistance Training
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Also called Strength Training
24-weeks of progressive strength training
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | These participants will be instructed to maintain their habits during 24 weeks. Before and after the aforementioned period, they will be asked to perform body composition and strength assessments, using DXA and isokinetic dynamometer, respectively. |
| Experimental group | Experimental | Participants from the experimental group will assign to the resistance training program undergo physician screening at rest and under cardiopulmonary exercise test conditions before starting the program. Following a three-week familiarization process, participants undergo one repetition maximum (1-RM) testing for each of the exercises of the training program. This procedure intended to determine exercise load and will be systematically repeated in four-week intervals. Volunteers will train thrice per week during 24 weeks. The training program will involve the following exercises: chest press, lat pulldown, knee extension, hamstrings curl, leg press, hip abduction. Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratorial Body Composition assessment (DXA)
DXA-derived body fat and DXA-derived fat free mass
Measured: 30 minutes
Secondary outcomes (1)
Isokinetic peak torque of leg extension (dynamometer isokinetic)
Dominant leg extension peak torque will be recorded in three sets of maximal effort
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Moreno Lima, University of Brasilia
- Investigators
- Ricardo M Lima, PhD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681744
- Sponsor's protocol ID
- 487622/2012-0
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Sarcopenic Obesity Index in Older Women: a RCT.
- ClinicalTrials.gov ID
- NCT02681744
- Acronym / sponsor ID
- 487622/2012-0
- Conditions
- Sarcopenia, Aging, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- 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.
The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.
Detailed description
To examine the effects of resistance training on sarcopenic obesity in older women, a representative sample of older women from Brasília, Brazil (n>244 subjects), will be recruited and invited to undergo body composition measurement using dual-energy x-ray absorptiometry. Moreover, the Sarcopenic Obesity index and isokinetic strength evaluations will be performed. It will be a single-blind randomized, controlled 24-week clinical trial, in which experimental group will receive a progressive resistance training program, meanwhile control group will receive instructions to maintain their lifestyle habits. Randomization will be conducted by computer-generated list in blocks of 10. Additionally, body composition, strength assessment, and sarcopenic index will collected and compared after the intervention period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –These participants will be instructed to maintain their habits during 24 weeks. Before and after the aforementioned period, they will be asked to perform body composition and strength assessments, using DXA and isokinetic dynamometer, respectively. |
| Experimental group | Experimental | Behavioral: Resistance TrainingParticipants from the experimental group will assign to the resistance training program undergo physician screening at rest and under cardiopulmonary exercise test conditions before starting the program. Following a three-week familiarization process, participants undergo one repetition maximum (1-RM) testing for each of the exercises of the training program. This procedure intended to determine exercise load and will be systematically repeated in four-week intervals. Volunteers will train thrice per week during 24 weeks. The training program will involve the following exercises: chest press, lat pulldown, knee extension, hamstrings curl, leg press, hip abduction. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community older women (aged between 60 and 80 years).
Key exclusion criteria (1 listed)
- individuals with any metallic implant or artificial pacemaker, who had undergone hip surgery, who were unable to walk without assistance and those affected by metabolic or endocrine disorders that affect the muscular system.
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 |
|---|---|---|
| Resistance TrainingAlso: Strength Training24-weeks of progressive strength training | Behavioural | Experimental group |
Primary outcome
Laboratorial Body Composition assessment (DXA)
Time frame: 30 minutes
DXA-derived body fat and DXA-derived fat free mass
1 secondary outcome
Isokinetic peak torque of leg extension (dynamometer isokinetic)
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Ricardo M Lima, PhD principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Sarcopenia and Aging, run by University of Brasilia at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo M Lima, PhD (+556184908490, gefsunb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratorial Body Composition assessment (DXA) (time frame: 30 minutes). 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 15 Feb 2016.