OsteoporosisNCT03448276
Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia
A study testing Training in the vibrating platform and Walk in people with Osteoporosis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Training in the vibrating platform and Walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2018to 8 Aug 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
- Patients without severe neurological disease, vascular disorders, labyrinthitis and blindness;
- No use of gait auxiliaries;
- No history of fractures of the lower limbs in the last year;
- Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points) accordance with the usual physical activity questionnaire (QAFH).
Who cannot join
- -Patients who submit to hypertensive peak, nausea and dizziness during the training program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect Of Whole-Body Vibration And Walk Over Muscle Strength, Balance And Functional Performance In Elderly People With Osteoporosis And Osteopenia: Clinical Randomized Controlled Trial
Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and providing beneficial effects in bone metabolism. Stress induced by more vigorous activities such as weight lifting, increases the risk of injury, particularly in the elderly. Therefore, alternative strategies with lower risk of injury are indicated such as whole body vibration and walk.
Objective: Compare the effect whole body vibration and walking on muscular strength, balance and functional performance in the elderly with Osteoporosis and Osteopenia
Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will follow the guidelines established in the Consolidated Standards of Reporting Trials (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session. All participants will be subjected to the initial and final assessment.
- Conditions
- Osteoporosis
- Being tested
- Training in the vibrating platform, Walk
- Keywords
- Osteoporosis, Muscle Strength, Postural Balance, Vibration, Walking
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the vibrating platformOther
20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.
WalkOther
Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.
| Study group | Role | What they receive |
|---|---|---|
| Training in the vibrating platform | Experimental | 20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. Receives: Other: Training in the vibrating platform |
| Walk | Active comparator | Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. Receives: Other: Walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Test of 1 repetition maximum (1RM)
Measured: 20 minutes
Balance
Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.
Measured: 20 minutes
Functional performance
Timed Up and Go test (TUG)
Measured: 20 minutes
Balance
Stabilometry by Baropodometry
Measured: 20 minutes
Secondary outcomes (1)
Plantar pressure distribution
Baropodometry
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 posted28 Feb 2018
- Study start26 Feb 2018
- Primary completion9 Jan 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Parallel groups
- Model description
- Two groups: The experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448276
- Sponsor's protocol ID
- Vibration, Walk And Osteop
- Other IDs
- CAAE N. 80679117.5.0000.5208
- Status last verified
- Oct 2019
- First submitted
- 2 Feb 2018
- Last updated
- 22 Oct 2019
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect Of Whole-Body Vibration And Walk Over Muscle Strength, Balance And Functional Performance In Elderly People With Osteoporosis And Osteopenia: Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03448276
- Acronym / sponsor ID
- Vibration, Walk And Osteop
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Muscle Strength, Postural Balance, Vibration, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 28 Feb 2018 (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.
Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and providing beneficial effects in bone metabolism. Stress induced by more vigorous activities such as weight lifting, increases the risk of injury, particularly in the elderly. Therefore, alternative strategies with lower risk of injury are indicated such as whole body vibration and walk.
Objective: Compare the effect whole body vibration and walking on muscular strength, balance and functional performance in the elderly with Osteoporosis and Osteopenia
Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will follow the guidelines established in the Consolidated Standards of Reporting Trials (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session. All participants will be subjected to the initial and final assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two groups: The experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session.
| Arm | Type | Receives |
|---|---|---|
| Training in the vibrating platform | Experimental | Other: Training in the vibrating platform20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. |
| Walk | Active comparator | Other: WalkWill be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
- Patients without severe neurological disease, vascular disorders, labyrinthitis and blindness;
- No use of gait auxiliaries;
- No history of fractures of the lower limbs in the last year;
- Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points) accordance with the usual physical activity questionnaire (QAFH).
Key exclusion criteria (1 listed)
- -Patients who submit to hypertensive peak, nausea and dizziness during the training program.
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 |
|---|---|---|
| Training in the vibrating platform20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. | Other | Training in the vibrating platform |
| WalkWill be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling. | Other | Walk |
Primary outcome
Muscular strength
Time frame: 20 minutes
Test of 1 repetition maximum (1RM)
Balance
Time frame: 20 minutes
Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.
Functional performance
Time frame: 20 minutes
Timed Up and Go test (TUG)
Balance
Time frame: 20 minutes
Stabilometry by Baropodometry
1 secondary outcome
Plantar pressure distribution
Time frame: 20 minutes
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 Oct 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the vibrating platform and Walk in people with Osteoporosis, run by Universidade Federal de Pernambuco 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 5 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 Oct 2019. 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?
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?
Muscular strength (time frame: 20 minutes). The study lists 4 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 Oct 2019.