Effect of the Otago Programme Delivered as Home Exercise or Group Exercise

Accidental Falls Clinical Trial

— FALLFOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313481
• Other study ID #: 6.2008.1352
• Status: Completed
• Phase: N/A
• First received: March 22, 2010
• Last updated: July 18, 2016
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Accidental Falls
• Distorted Balance

Intervention

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

Locations

Country	Name	City	State
Norway	Vestfold hospital	Tonsberg	Vestfold

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Fund for Postgraduate Training in Physiotherapy, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Kyrdalen IL, Moen K, Røysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Balance by use of the Berg Balance Scale		3 months	No
Secondary	Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version		3 and 6 months	No
Secondary	Mobility by the Timed Get up-and-go		3 and 6 months	No
Secondary	Functional leg muscle strength by a Sit-to-stand test	Number of raise-up trials in 30 sec, picked from the Senior Fitness test	3 and 6 months	No
Secondary	Health related quality of life by the Short Formular 36 (SF-36)		3 and 6 months	No