FallSAFETRIPNCT05207215
Study on the Steps to Avoid Falls in the Elderly
A study testing Home Base Exercises in people with Fall and Fall Prevention, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This study focuses on administering home-based exercises which include balance, strength, endurance, and mobility training to pre-frail subjects via one of the 3 intervention arms. These evidence-based home exercises are performed two times a week for 12 weeks (3 months). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Fall, Fall Prevention, Pre- Frail
- What is being tested?
- Home Base Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2020to 1 Jul 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 60 years
- Singapore citizen or Permanent Resident
- With or without fall history in the last one year
- Short Physical Performance Battery (SPPB) >= 6
- Ability to provide informed consent
- Has not more than 1 major comorbidity (Heart attack, heart failure, cerebrovascular disease \& cancer)
- Abbreviated Mental Test (AMT) >= 6
- Not referred for further active rehabilitation with a physiotherapist after discharge from hospital or outpatient care.
Who cannot join
- Patients who are advised by their physicians not to participate in physical activity sessions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Video Consultation, Computer Gaming and Self-help Home Exercises as Steps to Avoid Falls in the Elderly
This study focuses on administering home-based exercises which include balance, strength, endurance, and mobility training to pre-frail subjects via one of the 3 intervention arms. These evidence-based home exercises are performed two times a week for 12 weeks (3 months). A follow-up assessment will be conducted at the end of 9 months after 6 months maintenance phase.
Read the detailed description
Falls are the most common morbid and expensive health condition involving older adults. The range of exercises included in the SAFE programme is designed to be adaptable to a wide range of physical functions targeting pre-frail older adults. The exact exercises will vary on the patients' functional status. However, all exercise sessions must include balance exercises that challenge the patient's balance during static activities, during movement and also may include challenges as the patient has divided attention (walking and talking, walking while carrying objects). Balance is first emphasised followed by strengthening exercises of the lower extremities. The improvement in walking, physical activity and endurance, is dependent on the patients' improvement in balance and strength. The overall design of the intervention is to develop and maintain functional mobility by targeting deficiencies in balance, strength, mobility, and endurance.
Despite efforts to provide exercises to improve patients' balance and strength to prevent falls, many do not comply with the programme upon discharge. To address this challenge, the investigators propose to conduct a pilot study that will employ novel approaches, using an evidence-based, person-centred falls prevention intervention (SAFE programme), which is sustainable and cost-effective for the general public in Singapore. These three interventions in the study include video conferencing, newly created exercise games (Gamification) and a self-guided home exercise programme.
A key aspect of the SAFE exercise programme is its simple yet structured series of exercises, with gradual progression, to improve balance, mobility and lower limb strength. It is important that subjects continually challenge themselves during the exercise sessions to promote ongoing improvement in physical function. An exercise stratification grid has been developed to help guide the subjects on the types of exercises and level of intensity, that will be appropriate for them. Performance level (as defined in the stratification grid) should be re-assessed weekly so as to track the progress of the subject i.e. once a subject has achieved the level of the specified exercise in a category, the participants will progress to the next level for the same category. In addition, the subjects will be encouraged to participate in walking both, as much and as far as possible, to improve their functional capacity. Therefore, the SAFE exercises are very appropriate to be used in the home setting.
140 pre-frail subjects discharged from SKH, SGH and OCH will be recruited for the study. Only those who meet the requirements criteria using the Ward PT Checklist will be randomised into the 3 intervention groups. All groups are required to exercise at least twice a week and complete the intervention over a 3-month period. Baseline, 3- and 9-months follow-up data will be collected by independent assessors. Outcome measures in 9 categories will be measured and compared across the 3 groups. These measures will be correlated to the subject's compliance to the intervention and effectiveness will be compared between the 3 groups.
- Conditions
- Fall, Fall Prevention, Pre- Frail
- Being tested
- Home Base Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Base ExercisesOther
The study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Video Conferencing | Active comparator | Video conferencing is a 2-way interactive session that is enabled using telecommunication networks and the internet. The investigators will be working with 3rd party provider to create the video conferencing platform. Subjects can login to do SAFE exercises while physiotherapists monitor remotely. Subjects will complete two sessions per week (1hour for each session) for 12 weeks. Receives: Other: Home Base Exercises |
| Group B: Gamification | Active comparator | Gamification refers to exercise-driven gaming, where games are developed with specifications/parameters that incorporate exercise movements. Currently, the investigators have an ongoing pilot study on game-assisted rehabilitation at SGH Physiotherapy Outpatient clinic and the exercise games are developed by an external company. The investigators will engage an external company to develop exercise games based on the exercises used in SAFE programme. Each game will have different difficulty levels to provide progressive training for subjects Receives: Other: Home Base Exercises |
| Group C: Self Guided | Active comparator | Subjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves. Receives: Other: Home Base Exercises |
| Group D: Self Guided | Placebo comparator | Subjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves. Receives: Other: Home Base Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
To monitor the change of SPBB over the study period
The SPBB will be captured at 3 time points (1st during the baseline, 2nd during the 3rd month post assessment and 3rd during the 9 month post assessment). Direct measurement will be taken by the assessor.
Measured: Baseline, 3rd month and 9th month
Secondary outcomes (9)
Patient Demographic Profile
The following will be collected Age, gender, ethnicity, marital status via an interview
Measured: Baseline, 3rd month and 9th month
Profile of the Caregiver
This profile will be collected via an Interview
Measured: Baseline, 3rd month and 9th month
Health Status: Presence of diseases
This information will be collected via an interview
Measured: Baseline, 3rd month and 9th month
Health Status: Lawton IADL
This information will be collected via an interview
Measured: Baseline, 3rd month and 9th month
History & Attitude Towards Falls
This information will be collected via an interview
Measured: Baseline, 3rd month and 9th month
Social Network & Social Isolation
Variables for Lubben Social Network Scale (LSNS-6) are collected via interview.
Measured: Baseline, 3rd month and 9th month
Healthcare Utilisation
The following variables are collected via interview:
- Number of visits by the participants to the Accident \& Emergency Department
- Number of hospital admissions by the participants
- Number of visits by the participants to the General practitioner
Measured: Baseline, 3rd month and 9th month
Quality of Life Characteristics
Variables for EQ-5D-5L are collected via interview.
Measured: Baseline, 3rd month and 9th month
Compliance of the different Intervention
Variables for compliance are being collected via log book and weekly calls.
Measured: Baseline, 3rd month and 9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Nov 2020
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential multiple assignment randomized trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Sengkang General Hospital
- Responsible party
- Sponsor
- Investigators
- Celia IC Tan, PhD, Principal investigator, SingHealth Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207215
- Sponsor's protocol ID
- SAFE TRIP
- Acronym
- SAFETRIP
- Status last verified
- Apr 2023
- First submitted
- 26 Aug 2021
- Last updated
- 18 Apr 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Video Consultation, Computer Gaming and Self-help Home Exercises as Steps to Avoid Falls in the Elderly
- ClinicalTrials.gov ID
- NCT05207215
- Acronym / sponsor ID
- SAFETRIP / SAFE TRIP
- Conditions
- Fall, Fall Prevention, Pre- Frail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, Sengkang General Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 26 Jan 2022 (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.
This study focuses on administering home-based exercises which include balance, strength, endurance, and mobility training to pre-frail subjects via one of the 3 intervention arms. These evidence-based home exercises are performed two times a week for 12 weeks (3 months). A follow-up assessment will be conducted at the end of 9 months after 6 months maintenance phase.
Detailed description
Falls are the most common morbid and expensive health condition involving older adults. The range of exercises included in the SAFE programme is designed to be adaptable to a wide range of physical functions targeting pre-frail older adults. The exact exercises will vary on the patients' functional status. However, all exercise sessions must include balance exercises that challenge the patient's balance during static activities, during movement and also may include challenges as the patient has divided attention (walking and talking, walking while carrying objects). Balance is first emphasised followed by strengthening exercises of the lower extremities. The improvement in walking, physical activity and endurance, is dependent on the patients' improvement in balance and strength. The overall design of the intervention is to develop and maintain functional mobility by targeting deficiencies in balance, strength, mobility, and endurance.
Despite efforts to provide exercises to improve patients' balance and strength to prevent falls, many do not comply with the programme upon discharge. To address this challenge, the investigators propose to conduct a pilot study that will employ novel approaches, using an evidence-based, person-centred falls prevention intervention (SAFE programme), which is sustainable and cost-effective for the general public in Singapore. These three interventions in the study include video conferencing, newly created exercise games (Gamification) and a self-guided home exercise programme.
A key aspect of the SAFE exercise programme is its simple yet structured series of exercises, with gradual progression, to improve balance, mobility and lower limb strength. It is important that subjects continually challenge themselves during the exercise sessions to promote ongoing improvement in physical function. An exercise stratification grid has been developed to help guide the subjects on the types of exercises and level of intensity, that will be appropriate for them. Performance level (as defined in the stratification grid) should be re-assessed weekly so as to track the progress of the subject i.e. once a subject has achieved the level of the specified exercise in a category, the participants will progress to the next level for the same category. In addition, the subjects will be encouraged to participate in walking both, as much and as far as possible, to improve their functional capacity. Therefore, the SAFE exercises are very appropriate to be used in the home setting.
140 pre-frail subjects discharged from SKH, SGH and OCH will be recruited for the study. Only those who meet the requirements criteria using the Ward PT Checklist will be randomised into the 3 intervention groups. All groups are required to exercise at least twice a week and complete the intervention over a 3-month period. Baseline, 3- and 9-months follow-up data will be collected by independent assessors. Outcome measures in 9 categories will be measured and compared across the 3 groups. These measures will be correlated to the subject's compliance to the intervention and effectiveness will be compared between the 3 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential multiple assignment randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Group A: Video Conferencing | Active comparator | Other: Home Base ExercisesVideo conferencing is a 2-way interactive session that is enabled using telecommunication networks and the internet. The investigators will be working with 3rd party provider to create the video conferencing platform. Subjects can login to do SAFE exercises while physiotherapists monitor remotely. Subjects will complete two sessions per week (1hour for each session) for 12 weeks. |
| Group B: Gamification | Active comparator | Other: Home Base ExercisesGamification refers to exercise-driven gaming, where games are developed with specifications/parameters that incorporate exercise movements. Currently, the investigators have an ongoing pilot study on game-assisted rehabilitation at SGH Physiotherapy Outpatient clinic and the exercise games are developed by an external company. The investigators will engage an external company to develop exercise games based on the exercises used in SAFE programme. Each game will have different difficulty levels to provide progressive training for subjects |
| Group C: Self Guided | Active comparator | Other: Home Base ExercisesSubjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves. |
| Group D: Self Guided | Placebo comparator | Other: Home Base ExercisesSubjects in the self-guided exercise programme will be instructed to do SAFE exercises at least twice a week for an hour each by themselves. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 60 years
- Singapore citizen or Permanent Resident
- With or without fall history in the last one year
- Short Physical Performance Battery (SPPB) >= 6
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Patients who are advised by their physicians not to participate in physical activity sessions will be excluded from the study.
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 |
|---|---|---|
| Home Base ExercisesThe study developed 3 approaches that innovate beyond the existing delivery modes of the SAFE programme, by developing means for providing an intervention that is functionally equivalent to the SAFE programme but can be implemented in a patient's home. These home approaches include: (a) video conferencing; (b) gamification; and (3) self-guided home exercise programme. The investigators' task is to focus on developing these 3 modes and evaluating each in a pilot context for participants upon discharge from the hospital. | Other | Group A: Video Conferencing, Group B: Gamification, Group C: Self Guided, Group D: Self Guided |
Primary outcome
To monitor the change of SPBB over the study period
Time frame: Baseline, 3rd month and 9th month
The SPBB will be captured at 3 time points (1st during the baseline, 2nd during the 3rd month post assessment and 3rd during the 9 month post assessment). Direct measurement will be taken by the assessor.
9 secondary outcomes
Patient Demographic Profile
Time frame: Baseline, 3rd month and 9th month
Profile of the Caregiver
Time frame: Baseline, 3rd month and 9th month
Health Status: Presence of diseases
Time frame: Baseline, 3rd month and 9th month
Health Status: Lawton IADL
Time frame: Baseline, 3rd month and 9th month
History & Attitude Towards Falls
Time frame: Baseline, 3rd month and 9th month
Social Network & Social Isolation
Time frame: Baseline, 3rd month and 9th month
Healthcare Utilisation
Time frame: Baseline, 3rd month and 9th month
Quality of Life Characteristics
Time frame: Baseline, 3rd month and 9th month
Compliance of the different Intervention
Time frame: Baseline, 3rd month and 9th month
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 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Celia IC Tan, PhD principal investigator
SingHealth Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Base Exercises in people with Fall and Fall Prevention, run by Singapore General Hospital at 1 site in Singapore.
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 8 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 Apr 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
To monitor the change of SPBB over the study period (time frame: Baseline, 3rd month and 9th month). 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 Apr 2023.