NCT03464825

Brief Summary

Three months of balance training with follow-up 6 and 12 months thereafter.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable quality-of-life

Status
unknown

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

January 1, 2010

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

8 years

First QC Date

March 3, 2017

Last Update Submit

March 7, 2018

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Balance performance - one leg stand

    One leg stand during 30 seconds

    up to 24 months

Secondary Outcomes (2)

  • Fear of falling FES-I

    up to 24 months

  • Health related quality of life - SF-36

    up to 24 months

Study Arms (2)

Intervention

OTHER

Participants in the intervention group receive balance training during 3 months 3 times per week

Other: Specific and progressive balance training

Control

NO INTERVENTION

Care as usual

Interventions

Specific and progressive balance trainingOTHER

Specific and progressive balance training for the intervention group

Intervention

Eligibility Criteria

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

You may qualify if:

  • over 60 years with either osteoporosis or Parkinsons disease

You may not qualify if:

  • under 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One intervention group receiving Specific and progressive balance training One control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 14, 2018

Study Start

January 1, 2010

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share