Fall RiskFall RiskNCT02746835
Physical Condition and Self-efficacy in People With Fall Risk
A study testing Exercise program for fall prevention in people with Fall Risk, run by Aveiro University at 1 site in Portugal.
Trial summary
Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program. Two sessions per week were performed, during 6 weeks supervised by a physiotherapist. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fall Risk
- What is being tested?
- Exercise program for fall prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2015to Jan 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fall Risk (Morse scale)
Who cannot join
- Had no capacity to walk independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Condition and Self-efficacy in People With Fall Risk - a Preliminary Study
Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program.
Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.
At the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.
- Conditions
- Fall Risk
- Being tested
- Exercise program for fall prevention
- Keywords
- physical condition, self-efficacy, fall risk, exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program for fall preventionOther
Set of exercises to improve the following parameters:
balance, endurance, muscle strength, flexibility.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Protocol | Experimental | Set of exercises for balance, endurance, muscle strength and flexibility Receives: Other: Exercise program for fall prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy moving indoors
Question 1- Self-efficacy moving indoors; (scoring: 0-not confident - 2-very confident)
Measured: 6-weeks
Self-efficacy moving outside
Question 2 - Self-efficacy moving outside (scoring: 0-not confident - 2-very confident)
Measured: 6-weeks
Self-efficacy walking uneven surfaces
Question 3- Self-efficacy walking through uneven surfaces (scoring: 0-not confident - 2-very confident)
Measured: 6-weeks
Self-efficacy in physical activities
Question 4 - Self-efficacy participating in physical activities (scoring: 0-not confident - 2-very confident)
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Saúde de Anadia
- Responsible party
- Principal investigator, Marlene Rosa, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746835
- Sponsor's protocol ID
- Falls Prevention Program
- Acronym
- Fall Risk
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Condition and Self-efficacy in People With Fall Risk - a Preliminary Study
- ClinicalTrials.gov ID
- NCT02746835
- Acronym / sponsor ID
- Fall Risk / Falls Prevention Program
- Conditions
- Fall Risk
- Keywords
- physical condition, self-efficacy, fall risk, exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Centro de Saúde de Anadia
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 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.
Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program.
Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.
At the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Protocol | Experimental | Other: Exercise program for fall preventionSet of exercises for balance, endurance, muscle strength and flexibility |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fall Risk (Morse scale)
Key exclusion criteria (1 listed)
- Had no capacity to walk independently
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 |
|---|---|---|
| Exercise program for fall preventionSet of exercises to improve the following parameters: balance, endurance, muscle strength, flexibility. | Other | Exercise Protocol |
Primary outcome
Self-efficacy moving indoors
Time frame: 6-weeks
Question 1- Self-efficacy moving indoors; (scoring: 0-not confident - 2-very confident)
Self-efficacy moving outside
Time frame: 6-weeks
Question 2 - Self-efficacy moving outside (scoring: 0-not confident - 2-very confident)
Self-efficacy walking uneven surfaces
Time frame: 6-weeks
Question 3- Self-efficacy walking through uneven surfaces (scoring: 0-not confident - 2-very confident)
Self-efficacy in physical activities
Time frame: 6-weeks
Question 4 - Self-efficacy participating in physical activities (scoring: 0-not confident - 2-very confident)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program for fall prevention in people with Fall Risk, run by Aveiro University at 1 site in Portugal.
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 1 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: finished, as of the sponsor's last update on 21 Apr 2016. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-efficacy moving indoors (time frame: 6-weeks). The study lists 4 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 21 Apr 2016.