Cost-effectiveness of a proprioceptive exercise program in institutionalised elderly with fear of falling
| ISRCTN | ISRCTN21695765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21695765 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/06/2010
- Registration date
- 06/07/2010
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Narcis Gusi
Scientific
Scientific
Av de la Universidad, s/n
Cáceres
10003
Spain
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Cost-effectiveness of a proprioceptive exercise program in institulionalised elderly with fear of falling: randomised controlled trial |
| Study objectives | 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(s) | Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 30/2010) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2010 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Av de la Universidad, s/n
Cáceres
10003
Spain
10003
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Av de Elvas s/n
Badajoz
06071
Spain
| Website | http://www.unex.es/ |
|---|---|
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
University/education
University of Extremadura (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | 23/10/2020 | Yes | No |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
