Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/06/2010
Date assigned
06/07/2010
Last edited
06/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Av de la Universidad
s/n
Cáceres
10003
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cost-effectiveness of a proprioceptive exercise program in institulionalised elderly with fear of falling: randomised controlled trial

Acronym

Study hypothesis

1. Proprioceptive exercise program will reduce fear of falling in institutionalised elderly with fear of falling
2. Proprioceptive exercise program will improve static and dynamic balance in institutionalised elderly with fear of falling
3. Proprioceptive exercise program will reduce the risk of falling in institutionalised elderly with fear of falling
4. Proprioceptive exercise program is a cost-effective addition to usual care in in institutionalised elderly with fear of falling

Ethics approval

Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 30/2010)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Fear of falling

Intervention

The participants will be randomly assigned to intervention or control group by a random table built by computer:
1. Interventional group: three-month progressive proprioceptive exercise program, applied twice a week
2. Control group: care as usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at baseline and three months:
1. Falls Efficacy Scale International (FES-I)
2. Balance (Fall risk and postural stability) measured by Biodex Balance
2. Muscular function (isokinetic measurements) measured by System-3 Biodex Dynamometer
3. Health related quality of life:
3.1. EuroQol EQ-5D Instrument (utility index)
3.2. 36-item Short Form Health Survey (SF-36) (utility index)
4. Fitness
5. Health system and societal costs

Secondary outcome measures

Measured at baseline and three months:
1. Grade of satisfaction with programme
2. Weight, % fat

Overall trial start date

01/07/2010

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with fear of falling (Falls Efficacy Scale International [FES-I] Score, 16 item questionnaire, greater than 23)
2. Institutionalised people
3. Informed consent
4. Aged 65 years and older, male and female
5. Ability to understand instructions

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. To have an artificial prosthesis
2. Other physical or psychological therapies different from usual care in the National Health Service and the nursing home
3. Show symptoms during the medical examination to recommend their exclusion
4. Cognitive disease
5. Any drug intake that may affect balance significantly - to avoid external influences

Recruitment start date

01/07/2010

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Av de la Universidad, s/n
Cáceres
10003
Spain

Sponsor information

Organisation

University of Extremadura (Spain)

Sponsor details

Av de Elvas s/n
Badajoz
06071
Spain

Sponsor type

University/education

Website

http://www.unex.es/

Funders

Funder type

University/education

Funder name

University of Extremadura (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes