Geriatric DisorderFFALL_GERNCT02727374
Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls
A study testing Physiotherapy intervention and Cognitive-behavioural Intervention in people with Geriatric Disorder, run by University of Valencia at 1 site in Spain.
Trial summary
Fear to fall has been proven to be a risk factor affecting those geriatric patients who have previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy and psychological combined intervention, aimed at reducing the fear to fall in the aforementioned patients Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Physiotherapy intervention and Cognitive-behavioural Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling older people
- Looking for Physiotherapy attendance
- Patients who have suffered at least one fall episode
- Patients with fear of falling
Who cannot join
- Some cognitive affection that may affect the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Fear to fall has been proven to be a risk factor affecting those geriatric patients who have previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy and psychological combined intervention, aimed at reducing the fear to fall in the aforementioned patients
Read the detailed description
One of the main consequences of falling is the fear to fall again. This involves changes in the elderly behaviour which leads to a reduction of the physical activity, higher need of cares, reduction of the quality of life and risk of social isolation. In this framework, this works is aimed at performing a treatment to reduce the fear to fall in those geriatrics patients with previous falls, based on the combination of physical activity, health education and cognitive-behavioural psychological treatment targeted to this effect. The reason is that literature points at combined treatment use to present higher effectiveness
- Conditions
- Geriatric Disorder
- Being tested
- Physiotherapy intervention, Cognitive-behavioural Intervention
- Keywords
- Fear to Fall, Geriatric, Rehabilitation, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy interventionOther
Physiotherapy intervention consists of conventional exercise program administered to this kind of patients at Hospital Clinico, including strengthening and balance exercises
Cognitive-behavioural InterventionBehavioural
Psychological treatment consists of group talks to treat the fear to fall
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Experimental | Physiotherapy intervention, plus cognitive-behavioural intervention Receives: Other: Physiotherapy intervention; Behavioral: Cognitive-behavioural Intervention |
| CONTROL | Active comparator | Physiotherapy intervention Receives: Other: Physiotherapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Related Psychological Concerns (Falls)
Assessed in terms of the Falls Efficacy Scale International (FES-I) results
Measured: Prospective change from baseline to end of intervention (8 weeks)
Fear Related Psychological Concerns (Balance)
Assessed in terms of the Activities-Specific Balance Confidence (ABC) scale results
Measured: Prospective change from baseline to end of intervention (8 weeks)
Fear Related Psychological Concerns (Fear)
Assessed in terms of the Visual Analog Scale results (0-10)
Measured: Prospective change from baseline to end of intervention (8 weeks)
Secondary outcomes (3)
Risk of Falling
Assessed in terms of the Timed up \& Go test
Measured: Prospective change from baseline to end of intervention (8 weeks)
Center Epidemiological Studies Depression Scale
This is a measurement scale of depression
Measured: Prospective change from baseline to end of intervention (8 weeks)
Ryff Scale
It is a scale for measuring psychological well-being
Measured: Prospective change from baseline to end of intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celedonia Igual, University of Valencia
- Investigators
- Celedonia Igual, Professor, Principal investigator, University of ValenciaJose M Blasco, PhD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727374
- Sponsor's protocol ID
- CI_UValencia1
- Acronym
- FFALL_GER
- Status last verified
- Jun 2017
- First submitted
- 22 Mar 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear to Fall Reduction in Geriatric Patients Who Suffered Previous Falls
- ClinicalTrials.gov ID
- NCT02727374
- Acronym / sponsor ID
- FFALL_GER / CI_UValencia1
- Conditions
- Geriatric Disorder
- Keywords
- Fear to Fall, Geriatric, Rehabilitation, Psychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fear to fall has been proven to be a risk factor affecting those geriatric patients who have previously suffered a fall. In this work it is assessed the effectiveness of a physiotherapy and psychological combined intervention, aimed at reducing the fear to fall in the aforementioned patients
Detailed description
One of the main consequences of falling is the fear to fall again. This involves changes in the elderly behaviour which leads to a reduction of the physical activity, higher need of cares, reduction of the quality of life and risk of social isolation. In this framework, this works is aimed at performing a treatment to reduce the fear to fall in those geriatrics patients with previous falls, based on the combination of physical activity, health education and cognitive-behavioural psychological treatment targeted to this effect. The reason is that literature points at combined treatment use to present higher effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Other: Physiotherapy intervention, Behavioral: Cognitive-behavioural InterventionPhysiotherapy intervention, plus cognitive-behavioural intervention |
| CONTROL | Active comparator | Other: Physiotherapy interventionPhysiotherapy intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community-dwelling older people
- Looking for Physiotherapy attendance
- Patients who have suffered at least one fall episode
- Patients with fear of falling
Key exclusion criteria (1 listed)
- Some cognitive affection that may affect the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy interventionPhysiotherapy intervention consists of conventional exercise program administered to this kind of patients at Hospital Clinico, including strengthening and balance exercises | Other | CONTROL, EXPERIMENTAL |
| Cognitive-behavioural InterventionPsychological treatment consists of group talks to treat the fear to fall | Behavioural | EXPERIMENTAL |
Primary outcome
Fear Related Psychological Concerns (Falls)
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Assessed in terms of the Falls Efficacy Scale International (FES-I) results
Fear Related Psychological Concerns (Balance)
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Assessed in terms of the Activities-Specific Balance Confidence (ABC) scale results
Fear Related Psychological Concerns (Fear)
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Assessed in terms of the Visual Analog Scale results (0-10)
3 secondary outcomes
Risk of Falling
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Center Epidemiological Studies Depression Scale
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Ryff Scale
Time frame: Prospective change from baseline to end of intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celedonia Igual, Professor principal investigator
University of Valencia
Jose M Blasco, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy intervention and Cognitive-behavioural Intervention in people with Geriatric Disorder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear Related Psychological Concerns (Falls) (time frame: Prospective change from baseline to end of intervention (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.