- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920151
Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty (BECA)
September 28, 2016 updated by: Marisete Peralta Safons, Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- more than one year of postoperative total hip or knee arthroplasty
Exclusion Criteria:
- total hip AND knee arthroplasty
- other surgeries of the lower limbs and spine
- autoimmune disease
- contraindication for physical exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BALANCE EXERCISES CIRCUIT
balance exercises circuit for three months, twice weekly, 50 minutes per day.
|
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
Other Names:
|
No Intervention: CONTROL GROUP
usual routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: three months
|
evaluates functional balance
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickScreen scale
Time Frame: three months
|
fall risk assessement
|
three months
|
Falls Efficacy Scale
Time Frame: three months
|
self-efficacy or confidence in performing activities without falling
|
three months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
static balance
Time Frame: three months
|
static balance assessed by force plate
|
three months
|
Timed Up and Go
Time Frame: three months
|
functional performance and functional balance
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marisete P Safons, Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
September 12, 2016
First Submitted That Met QC Criteria
September 28, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Estimate)
September 30, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Gepafi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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