NCT01313481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

March 22, 2010

Last Update Submit

July 18, 2016

Conditions

Keywords

Older personsExerciseBalance

Outcome Measures

Primary Outcomes (1)

  • Functional Balance by use of the Berg Balance Scale

    3 months

Secondary Outcomes (4)

  • Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version

    3 and 6 months

  • Mobility by the Timed Get up-and-go

    3 and 6 months

  • Functional leg muscle strength by a Sit-to-stand test

    3 and 6 months

  • Health related quality of life by the Short Formular 36 (SF-36)

    3 and 6 months

Study Arms (2)

Group exercise

EXPERIMENTAL

Otago exercise performed in groups

Behavioral: Group exercise

Home exercise

ACTIVE COMPARATOR

Otago exercise performed as home exercise

Behavioral: Home exercise

Interventions

Group exerciseBEHAVIORAL

Otago exercise performed in groups of 4-8 patients, 2 times a week over 12 weeks

Group exercise
Home exerciseBEHAVIORAL

Otago exercise performed as home exercise 3 times a weeks over 12 weeks. Individually tailored physical balance and muscle strength exercise

Home exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold hospital

Tønsberg, Vestfold, N-3103, Norway

Location

Related Publications (1)

  • Kyrdalen IL, Moen K, Roysland 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 2013 Dec 11.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jorunn L Helbostad, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 11, 2011

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations