HealthyNCT02852642
Plyometric Training for Elderly Women
A study testing Exercise in people with Healthy, run by University of Sao Paulo.
Trial summary
Introduction: the physiological aging process induces several structural changes in the musculoskeletal system. These, in turn, result in functional changes that are reflected in the senescent dependency, determining the reduction in their quality of life. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jul 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sedentary women, not using bone alteration medication physically able
Who cannot join
- attending less than 80% of the intervention sessions and not attending the final evaluation
About this study
Official title: Structure and Musculoskeletal Function, Functional Capacity and Quality of Life of Elderly Women in Response to a Plyometric Training Model Based on the Stretch-shortening Cycle
Introduction: the physiological aging process induces several structural changes in the musculoskeletal system. These, in turn, result in functional changes that are reflected in the senescent dependency, determining the reduction in their quality of life. Power training has been identified as ideal to mitigate the effects of aging. However, there are indications that an intervention based on the potentiation of the stretch-shortening cycle action is a better choice.
Read the detailed description
Study hypotheses: the participants of the proposed intervention will increase their bone mineral density, muscle volume, functional capacity and will show some improvement in their gait, as well as in their quality of life. Purposes: the main objective of this study was to propose a training model based in the potentiation of the stretch-shortening cycle action and assess its effects on selected parameters of musculoskeletal morphology, functional capacity and quality of life of elderly women.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- power training, plyometric training, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Plyometric training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Power training model based in the potentiation of the stretch-shortening cycle. Receives: Other: Exercise |
| Control | No intervention | Maintaining daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone microstructure
Tibia and radius trabecular and cortical bone density
Measured: through study completion, an average of 6 months
body composition
Lean and fat body mass
Measured: through study completion, an average of 6 months
gait kinematics
toe clearance: minimum vertical distance of the forefoot and the ground during swing phase
Measured: through study completion, an average of 6 months
balance
Center of pressure displacement
Measured: through study completion, an average of 6 months
function capacity assessment
timed up and go test
Measured: through study completion, an average of 6 months
electromyography gait analysis
Knee extensors and flexors muscles co-contraction during the gait cycle
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Pedro Pinho, University of Sao Paulo
- Investigators
- Alberto C Amadio, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852642
- Sponsor's protocol ID
- PlyoElderly
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structure and Musculoskeletal Function, Functional Capacity and Quality of Life of Elderly Women in Response to a Plyometric Training Model Based on the Stretch-shortening Cycle
- ClinicalTrials.gov ID
- NCT02852642
- Acronym / sponsor ID
- PlyoElderly
- Conditions
- Healthy
- Keywords
- power training, plyometric training, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Aug 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.
Introduction: the physiological aging process induces several structural changes in the musculoskeletal system. These, in turn, result in functional changes that are reflected in the senescent dependency, determining the reduction in their quality of life. Power training has been identified as ideal to mitigate the effects of aging. However, there are indications that an intervention based on the potentiation of the stretch-shortening cycle action is a better choice.
Detailed description
Study hypotheses: the participants of the proposed intervention will increase their bone mineral density, muscle volume, functional capacity and will show some improvement in their gait, as well as in their quality of life. Purposes: the main objective of this study was to propose a training model based in the potentiation of the stretch-shortening cycle action and assess its effects on selected parameters of musculoskeletal morphology, functional capacity and quality of life of elderly women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExercisePower training model based in the potentiation of the stretch-shortening cycle. |
| Control | No intervention | –Maintaining daily activities |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sedentary women, not using bone alteration medication physically able
Key exclusion criteria (1 listed)
- attending less than 80% of the intervention sessions and not attending the final evaluation
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 |
|---|---|---|
| ExercisePlyometric training | Other | Exercise |
Primary outcome
Bone microstructure
Time frame: through study completion, an average of 6 months
Tibia and radius trabecular and cortical bone density
body composition
Time frame: through study completion, an average of 6 months
Lean and fat body mass
gait kinematics
Time frame: through study completion, an average of 6 months
toe clearance: minimum vertical distance of the forefoot and the ground during swing phase
balance
Time frame: through study completion, an average of 6 months
Center of pressure displacement
function capacity assessment
Time frame: through study completion, an average of 6 months
timed up and go test
electromyography gait analysis
Time frame: through study completion, an average of 6 months
Knee extensors and flexors muscles co-contraction during the gait cycle
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 2 Aug 2016.
- 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.
Alberto C Amadio, PhD study director
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy, run by University of Sao Paulo.
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: finished, as of the sponsor's last update on 2 Aug 2016. 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?
Bone microstructure (time frame: through study completion, an average of 6 months). The study lists 6 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 2 Aug 2016.