NCT02920151

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

September 12, 2016

Last Update Submit

September 28, 2016

Conditions

Hip ReplacementKnee ReplacementPostural Balance

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    evaluates functional balance

    three months

Secondary Outcomes (2)

  • QuickScreen scale

    three months

  • Falls Efficacy Scale

    three months

Other Outcomes (2)

  • static balance

    three months

  • Timed Up and Go

    three months

Study Arms (2)

BALANCE EXERCISES CIRCUIT

EXPERIMENTAL

balance exercises circuit for three months, twice weekly, 50 minutes per day.

Other: balance exercises circuit

CONTROL GROUP

NO INTERVENTION

usual routine

Interventions

balance exercises circuitOTHER

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

Also known as: exercises
BALANCE EXERCISES CIRCUIT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than one year of postoperative total hip or knee arthroplasty

You may not qualify if:

  • total hip AND knee arthroplasty
  • other surgeries of the lower limbs and spine
  • autoimmune disease
  • contraindication for physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marisete P Safons

    Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 30, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share