Hip ReplacementBECANCT02920151
Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty
A study testing balance exercises circuit in people with Hip Replacement and Knee Replacement, run by Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos.
Trial summary
This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Replacement, Knee Replacement, Postural Balance
- What is being tested?
- balance exercises circuit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than one year of postoperative total hip or knee arthroplasty
Who cannot join
- total hip AND knee arthroplasty
- other surgeries of the lower limbs and spine
- autoimmune disease
- contraindication for physical exercise
About this study
Official title: Effects of Balance Exercises Circuit in Patients With Total Hip or Knee Arthroplasty (BECA): A Randomized Clinical Trial
This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners.
Read the detailed description
Balance Exercise Circuit (BEC) program, includes exercise that specifically challenge sensory inputs from mechanoreceptors as well as from the visual and vestibular systems. It is composed of 13 stations, involving static and dynamic balance exercises, including tandem walking, forward-backward stepping, wide-stance gait, functional reach, heel lift, toe press, balance on unstable surfaces, and standing on one leg. The BEC lasts 50 min, two times per week for a total of 12 weeks. Progression of exercises occurred every 3 weeks and was closely supervised to ensure safety. Each BEC session comprised of warm-up and stretching (10 min), exercise circuit (30 min), and cool-down (10 min).
- Conditions
- Hip Replacement, Knee Replacement, Postural Balance
- Being tested
- balance exercises circuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance exercises circuitOther
Also called exercises
Thirteen workstations were organized in a circuit format on involved multidirectional gait in different bases of support, unstable surfaces, functional reach, exercise with balls, and single-leg stance
| Study group | Role | What they receive |
|---|---|---|
| BALANCE EXERCISES CIRCUIT | Experimental | balance exercises circuit for three months, twice weekly, 50 minutes per day. Receives: Other: balance exercises circuit |
| CONTROL GROUP | No intervention | usual routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
evaluates functional balance
Measured: three months
Secondary outcomes (2)
QuickScreen scale
fall risk assessement
Measured: three months
Falls Efficacy Scale
self-efficacy or confidence in performing activities without falling
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ReplacementStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marisete Peralta Safons, Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
- Investigators
- Marisete P Safons, Principal investigator, Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920151
- Sponsor's protocol ID
- Gepafi
- Acronym
- BECA
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Exercises Circuit in Patients With Total Hip or Knee Arthroplasty (BECA): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02920151
- Acronym / sponsor ID
- BECA / Gepafi
- Conditions
- Hip Replacement, Knee Replacement, Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Grupo de Estudos e Pesquisas Sobre Atividade Física Para IdososUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Sep 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.
This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners.
Detailed description
Balance Exercise Circuit (BEC) program, includes exercise that specifically challenge sensory inputs from mechanoreceptors as well as from the visual and vestibular systems. It is composed of 13 stations, involving static and dynamic balance exercises, including tandem walking, forward-backward stepping, wide-stance gait, functional reach, heel lift, toe press, balance on unstable surfaces, and standing on one leg. The BEC lasts 50 min, two times per week for a total of 12 weeks. Progression of exercises occurred every 3 weeks and was closely supervised to ensure safety. Each BEC session comprised of warm-up and stretching (10 min), exercise circuit (30 min), and cool-down (10 min).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BALANCE EXERCISES CIRCUIT | Experimental | Other: balance exercises circuitbalance exercises circuit for three months, twice weekly, 50 minutes per day. |
| CONTROL GROUP | No intervention | –usual routine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- more than one year of postoperative total hip or knee arthroplasty
Key exclusion criteria (4 listed)
- total hip AND knee arthroplasty
- other surgeries of the lower limbs and spine
- autoimmune disease
- contraindication for physical exercise
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 |
|---|---|---|
| balance exercises circuitAlso: exercisesThirteen workstations were organized in a circuit format on involved multidirectional gait in different bases of support, unstable surfaces, functional reach, exercise with balls, and single-leg stance | Other | BALANCE EXERCISES CIRCUIT |
Primary outcome
Berg Balance Scale
Time frame: three months
evaluates functional balance
2 secondary outcomes
QuickScreen scale
Time frame: three months
Falls Efficacy Scale
Time frame: three months
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 30 Sep 2016.
- Individual participant dataSharing planned: No
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Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
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RecruitingPhase 4
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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.
Marisete P Safons principal investigator
Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
Questions about this trial
What is this clinical trial studying?
A study testing balance exercises circuit in people with Hip Replacement and Knee Replacement, run by Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos.
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 4 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 30 Sep 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?
Berg Balance Scale (time frame: three months). 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 30 Sep 2016.