ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01313481
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : July 19, 2016
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

Brief 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.

Condition or disease Intervention/treatment Phase
Accidental Falls Distorted Balance Behavioral: Group exercise Behavioral: Home exercise Not Applicable

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  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Functional Balance by use of the Berg Balance Scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version [ Time Frame: 3 and 6 months ]
  2. Mobility by the Timed Get up-and-go [ Time Frame: 3 and 6 months ]
  3. 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

  4. Health related quality of life by the Short Formular 36 (SF-36) [ Time Frame: 3 and 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01313481     History of Changes
Other Study ID Numbers: 6.2008.1352
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

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