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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02920151
Other study ID # Gepafi
Secondary ID
Status Completed
Phase N/A
First received September 12, 2016
Last updated September 28, 2016
Start date February 2015
Est. completion date August 2016

Study information

Verified date September 2016
Source Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
balance exercises circuit
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos

Outcome

Type Measure Description Time frame Safety issue
Other static balance static balance assessed by force plate three months No
Other Timed Up and Go functional performance and functional balance three months No
Primary Berg Balance Scale evaluates functional balance three months No
Secondary QuickScreen scale fall risk assessement three months No
Secondary Falls Efficacy Scale self-efficacy or confidence in performing activities without falling three months No
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