Effect of the Otago Programme Delivered as Home Exercise or Group Exercise (FALLFOR)

July 18, 2016 updated by: Norwegian University of Science and Technology

A Randomized Controlled Trial of the Effect of Otago Exercise Delivered as Home Exercise or Group Exercise in Fall-prone Older Persons

The study aims to assess the effect on functional balance of Otago exercise performed as home exercise versus group exercise. The investigators hypothesize that Otago exercise is more effective performed as group exercise than home exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study sample is drawn from persons referred to a falls outpatient clinic. Group exercise and home exercise are delivered by trained physiotherapists. Home exercise follows the original Otago exercise protocol. Group exercise is performed twice a week. The length of the intervention period is 3 months. The main outcome measure is the Berg Balance Scale.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vestfold
      • Tonsberg, Vestfold, Norway, N-3103
        • Vestfold hospital

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • referred to an outpatient falls clinic
  • have fallen previous year or have gait or balance problems

Exclusion Criteria:

  • Mini Mental Status Examination (MMSE) < 22
  • Not able to walk 10 m without support from another person

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group exercise
Otago exercise performed in groups
Behavioral: Group exercise
Otago exercise performed in groups of 4-8 patients, 2 times a week over 12 weeks
ACTIVE_COMPARATOR: Home exercise
Otago exercise performed as home exercise
Behavioral: Home exercise
Otago exercise performed as home exercise 3 times a weeks over 12 weeks. Individually tailored physical balance and muscle strength exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Balance by use of the Berg Balance Scale
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version
Time Frame: 3 and 6 months
3 and 6 months
Mobility by the Timed Get up-and-go
Time Frame: 3 and 6 months
3 and 6 months
Functional leg muscle strength by a Sit-to-stand test
Time Frame: 3 and 6 months
Number of raise-up trials in 30 sec, picked from the Senior Fitness test
3 and 6 months
Health related quality of life by the Short Formular 36 (SF-36)
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

South-Eastern Norway Regional Health Authority
Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators

  • Principal Investigator: Jorunn L Helbostad, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 10, 2011

First Posted (ESTIMATE)

March 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6.2008.1352

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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