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

This study has been completed.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01313481
First received: March 22, 2010
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Accidental Falls
Distorted Balance
Behavioral: Group exercise
Behavioral: Home exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effect of Otago Exercise Delivered as Home Exercise or Group Exercise in Fall-prone Older Persons

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Functional Balance by use of the Berg Balance Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Mobility by the Timed Get up-and-go [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Functional leg muscle strength by a Sit-to-stand test [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Number of raise-up trials in 30 sec, picked from the Senior Fitness test

  • Health related quality of life by the Short Formular 36 (SF-36) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313481

Locations
Norway
Vestfold hospital
Tonsberg, Vestfold, Norway, N-3103
Sponsors and Collaborators
Norwegian University of Science and Technology
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
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01313481     History of Changes
Other Study ID Numbers: 6.2008.1352
Study First Received: March 22, 2010
Last Updated: October 18, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Older persons
Exercise
Balance

ClinicalTrials.gov processed this record on August 26, 2014