FallTelehealthNCT06089213
Strategies for Preventing Falls in the Elderly
A study testing real-time intervention in people with Fall and Elderly, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Fall, Elderly, Prevention
- What is being tested?
- real-time intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2021to 2 Sep 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elderly fallers
Who cannot join
- neurological diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul, 90880-370
About this study
Official title: Effects of Two Strategies for Preventing Falls in the Elderly Through Telerehabilitation: A Randomized Clinical Trial
Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. However, the application of these programs may not be accessible to a large part of the elderly population. The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies. Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room. It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months. Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period. Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training. However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.
Read the detailed description
To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.
- Conditions
- Fall, Elderly, Prevention, Telehealth, Physical Therapy
- Being tested
- real-time intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time interventionOther
An individual exercise program will be carried out at home, supervised remotely via videoconference.
| Study group | Role | What they receive |
|---|---|---|
| Interactive services | Experimental | Otago exercises performed in "real-time" or "synchronous" mode of digital health care. It consists of direct communication between physiotherapist and the patient. Receives: Other: real-time intervention |
| Remote telemonitoring | Active comparator | Otago exercises performed remotely, using technologies such as messaging apps. It consists of indirect communication between physiotherapist and the patient. Receives: Other: real-time intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Falls
After the intervention periods, participants will be followed for another 16 weeks. Every week, recurrences of falls will be recorded via telephone calls. You will be asked whether there were falls in the period
Measured: four months
Secondary outcomes (5)
Concern of falls
The assessment will consist of Self-efficacy tests for Falls
Measured: through study completion, an average of 1 year
Balance
The assessment will consist of Timed-Up and Go test
Measured: through study completion, an average of 1 year
Arms Muscle strength
Palm Grip Strength
Measured: through study completion, an average of 1 year
Legs Muscle strength
Sitting and Rising from a Chair tests
Measured: through study completion, an average of 1 year
Functionality
Katz Index on elderly functionality evaluation for the analysis of basic activities
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2021
- Primary completion1 Sep 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Éder Kröeff Cardoso, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089213
- Sponsor's protocol ID
- HPSPoA
- Acronym
- Telehealth
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Strategies for Preventing Falls in the Elderly Through Telerehabilitation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06089213
- Acronym / sponsor ID
- Telehealth / HPSPoA
- Conditions
- Fall, Elderly, Prevention, Telehealth, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- 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.
Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. However, the application of these programs may not be accessible to a large part of the elderly population. The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies. Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room. It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months. Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period. Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training. However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.
Detailed description
To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive services | Experimental | Other: real-time interventionOtago exercises performed in "real-time" or "synchronous" mode of digital health care. It consists of direct communication between physiotherapist and the patient. |
| Remote telemonitoring | Active comparator | Other: real-time interventionOtago exercises performed remotely, using technologies such as messaging apps. It consists of indirect communication between physiotherapist and the patient. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elderly fallers
Key exclusion criteria (1 listed)
- neurological diseases
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 |
|---|---|---|
| real-time interventionAn individual exercise program will be carried out at home, supervised remotely via videoconference. | Other | Interactive services, Remote telemonitoring |
Primary outcome
Rate of Falls
Time frame: four months
After the intervention periods, participants will be followed for another 16 weeks. Every week, recurrences of falls will be recorded via telephone calls. You will be asked whether there were falls in the period
5 secondary outcomes
Concern of falls
Time frame: through study completion, an average of 1 year
Balance
Time frame: through study completion, an average of 1 year
Arms Muscle strength
Time frame: through study completion, an average of 1 year
Legs Muscle strength
Time frame: through study completion, an average of 1 year
Functionality
Time frame: through study completion, an average of 1 year
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 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Fall
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Perception of Action Opportunities for Obstacle Crossing in Parkinson's Disease
PARKINSON DISEASE (Disorder), Older Adults (65-85 Years)
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
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 real-time intervention in people with Fall and Elderly, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 18 Oct 2023. 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 Brazil. 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?
Rate of Falls (time frame: four months). 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 18 Oct 2023.