NCT01778972

Brief Summary

Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 29, 2021

Status Verified

April 1, 2019

Enrollment Period

6.1 years

First QC Date

January 16, 2013

Last Update Submit

September 28, 2021

Conditions

Keywords

Fall preventionHome exerciseStrength trainingBalance training

Outcome Measures

Primary Outcomes (1)

  • Frequence of falls will be measured with a monthly fall-calender

    A fall-calender with registration of falls on a monthly bases will be used to record falls. The fall-calender should be sent in each month. Falls will be followed-up with telephone interviews.

    Two year

Secondary Outcomes (3)

  • Fall-related injuries will be measured by telephone interviews.

    Two years

  • Physical performance will be measured with Short Physical Performance Battery (SPPB)

    Two years

  • Dynamic balance will be assessed with Mini-BESTest

    Two years

Other Outcomes (4)

  • Fall-related self-efficacy will be measured with Fall efficacy scale, Swedish version.

    Two years

  • Grip strength will be measured with Jamar Hand Dynamometer

    Two years

  • Physical Activity level will be measured with Frändin/Grimby activity scale.

    Two years

  • +1 more other outcomes

Study Arms (3)

Otago home training programme

EXPERIMENTAL

Otago home exercise programme was designed specifically to prevent fall. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Other: Otago home exercise programme

Motivational interviewing plus Otago

EXPERIMENTAL

This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.

Other: Motivational interviewing plus Otago

Control grop

NO INTERVENTION

Participants are instructed to live their ordinary lives.

Interventions

Otago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Otago home training programme

This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.

Motivational interviewing plus Otago

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older, community-dwelling, in need of homecare or rollator

You may not qualify if:

  • Cognitive impairment (below 25 on Mini Mental test) Not able to transfer independently indoors -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Homes

Uppsala, Sweden

Location

Homes

Västerås, Sweden

Location

Related Publications (2)

  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  • Arkkukangas M, Hultgren S. Implementation of motivational interviewing in a fall prevention exercise program: experiences from a randomized controlled trial. BMC Res Notes. 2019 May 14;12(1):270. doi: 10.1186/s13104-019-4309-x.

MeSH Terms

Conditions

Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Karin E Hellström, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR
  • Ann-Christin Johansson, PhD

    Mälardalens University, Sweden

    PRINCIPAL INVESTIGATOR
  • Anne Söderlund, Professor

    Mälardalens University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior Lecturer

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 29, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

September 29, 2021

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations