Prevention of Falls in Older Adults by Specific and Progressive Balance Training (BETA)

March 7, 2018 updated by: Agneta Stahle, Karolinska Institutet
Three months of balance training with follow-up 6 and 12 months thereafter.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 60 years with either osteoporosis or Parkinsons disease

Exclusion Criteria:

  • under 60 years

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Care as usual
Other: Intervention
Participants in the intervention group receive balance training during 3 months 3 times per week
Other: Specific and progressive balance training
Specific and progressive balance training for the intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance performance - one leg stand
Time Frame: up to 24 months
One leg stand during 30 seconds
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of falling FES-I
Time Frame: up to 24 months
Questionnaire measuring fear of falling
up to 24 months
Health related quality of life - SF-36
Time Frame: up to 24 months
Questionnaire measuring health related quality of life
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

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 (Actual)

January 1, 2010

Primary Completion (Actual)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • K2011-69P-20908-02-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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