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 measure
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 (if study stopped)
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
Total final enrolment
40
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
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
Basic results (scientific)
Publication list
2012 results in https://pubmed.ncbi.nlm.nih.gov/22613239/ (added 23/10/2020)