Reduction of fear of falling and associated increase in functional ability, activity level and quality of life in community-living older adults who are at risk for falling: a randomised controlled trial

ISRCTN ISRCTN43792817
DOI https://doi.org/10.1186/ISRCTN43792817
Secondary identifying numbers 014-91-052
Submission date
07/10/2004
Registration date
09/11/2004
Last edited
01/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof G.I.J.M. Kempen
Scientific

Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociolgy
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3882204
Email g.kempen@zw.unimaas.nl

Study information

Study designRandomised controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study objectivesFear of falling and associated activity restriction is common in older persons living in the community. Adverse consequences of fear of falling and associated activity restriction, like functional decline and falls, may have a major impact on physical, mental and social functioning of these persons. This paper presents the design of a trial evaluating a cognitive behavioural group intervention to reduce fear of falling and associated activity restriction in older persons living in the community.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedFear of falling in older adults in the community
InterventionThe intervention group receives a cognitive behavioural group intervention developed to reduce fear of falling and to promote physical, social, and functional activity. This intervention is derived from 'A Matter of Balance', which is developed and evaluated by Tennstedt and colleagues in Boston, US. The protocol is translated and adapted to the Dutch context. The intervention program consists of eight weekly group sessions of two hours and a booster session six months after the last session. The intervention aims to increase self-efficacy beliefs with regard to falling as well as the sense of control over falling.
The control group receives usual care, meaning they receive no intervention as a result of this trial.
Intervention typeOther
Primary outcome measureFear of falling and daily activity. Fear of falling is assessed by a single question "Are you afraid of falling?" (1= never to 5= always). Falls related self-efficacy is assessed by an adapted version of the Falls Efficacy Scale (FES). Daily activity is assessed by the Frenchay Activity Index (FAI). To assess activity restriction due to fear of falling a single question was incorporated in the questionnaire: "Do you avoid certain activities due to fear of falling?" (1= never to 5= always).
Secondary outcome measuresPsychological, physical and social functioning. The Hospital Anxiety and Depression Scale (HADS) assessed psychological functioning. Physical functioning is assessed by the ADL subscale of the Groningen Activity Restriction Scale (GARS). Social functioning is assessed by a social support measure (SSL) and by a loneliness question.
Overall study start date01/03/2002
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants540
Key inclusion criteriaAge 70 or older, living independently in the community, reporting fear of falling and associated activity restriction.
Key exclusion criteriaConfined to bed, restricted by permanent use of wheelchair, on waiting list for nursing home admission.
Date of first enrolment01/03/2002
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Universiteit Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

Maastricht University, The Netherlands
Not defined

Faculty of Health Sciences and Care and Public Health Research Institute
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3881738
Email voorlichting@facburfdgw.unimaas.nl
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 21/03/2005 Yes No
Results article results 01/08/2006 Yes No