Accidental FallsSafeStepRCTNCT03963570
The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People
A study testing Safe Step - digital exercise program in people with Accidental Falls, run by Umeå University at 1 site in Sweden.
Trial summary
The overall aim of the study is to evaluate the effectiveness of a digital self-management exercise program in preventing falls in community dwelling older people. Participants will be recruited in Sweden through the website (www.sakrasteg.se) providing study information. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Safe Step - digital exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,628 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2019to 5 May 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older
- Have fallen or experienced a decline in perceived postural balance during the last year
- Have access to a smartphone or a tablet and uses it regularly
- Have an own email address and uses it
- Ability to understand verbal and written instructions in Swedish
- Can rise from a standard height chair without a person helping
- Independently mobile without a walking aid indoors
Who cannot join
- Progressive disease where there is likely to be a decline in strength or balance over the next year
- Perceived memory dysfunction that affect everyday life activities
- Taking part in more than 3 hours each week of strenuous physical exercise which makes them out of breath (e.g. dance, gymnastics, gym exercises, running or skiing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People -The Safe Step Randomized Controlled Trial
The overall aim of the study is to evaluate the effectiveness of a digital self-management exercise program in preventing falls in community dwelling older people.
Participants will be recruited in Sweden through the website (www.sakrasteg.se) providing study information. On the website interested seniors will get information about the aim and procedures of the study as well as inclusion and exclusion criteria. If seniors themselves judge that they are eligible to participate in the study they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will be randomized to either an exercise intervention or a control group in a 1:1 ratio. The investigators aim to include 1400 participants and recruitment will be ongoing continuously for one year.
Read more
The exercise intervention is delivered through the Safe Step application, developed in co-creation with seniors and an interdisciplinary research team. Safe Step provides a large repository of evidence based exercises in video formats alongside falls preventive information and advice. With support of this application the user can compose an individualized exercise program with balance and strength exercises suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application during one year, with a recommendation of 30 minutes at least 3 times/week.
In addition to the exercise intervention the participants will every month get an email with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message. The exercise group will be compared to a control group that will receive the same information emails as the exercise group, but no individual exercise advice.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 month in addition the monthly fall reports. Due to the nature of the study, with no face to face contact, all outcome measures are self-reports and self-tests in digital surveys. The primary outcome is fall rate. The study follows the CONSORT guidelines and CONSORT EHEALTH criteria.
- Conditions
- Accidental Falls
- Being tested
- Safe Step - digital exercise program, Control group
- Keywords
- Accidental Falls, Prevention and control, Exercise, Exercise therapy/methods*, Aged, Aged 80 and over, Smartphone, Computers handheld, Motivation, Behaviour change, Postural balance, Health behaviour, mHealth, eHealth, Digital health, Self-management
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Step - digital exercise programBehavioural
After receiving the Safe Step application the participants view an instruction movie on how to use the application to create and progress their own individual exercise program. The exercises, presented in video format, are organized into 10 predetermined groups with a main focus to improve balance (3 groups), increase lower-limb strength (4 groups), and improve gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.
They can use the app to plan their exercises, set reminders, register their exercise, and view statistics of their progress. A virtual physiotherapist deliver motivational messages and feed-back. At the end of every month, of the 1 year intervention period, the participants will receive an email asking them to report any falls during the past month by answering a short digital survey. This message will provide a new video each month with general falls prevention information besides exercise.
Control groupBehavioural
Participants randomized to the control condition will only be given information. They will receive exactly the same email messages as the intervention group with falls prevention information and a request to report any falls. At the end of the 12 month intervention we will, in addition to the other questions, ask if they have started to do any exercises during the intervention period. After the 12 month follow-up assessment the control group will be offered the Safe Step application.
| Study group | Role | What they receive |
|---|---|---|
| Safe Step - digital exercise program | Experimental | Participants randomized to the experimental group will receive full access to the Safe Step application and create their own individual program of strength and balance exercises. During 1 year the participants are recommended to exercise at least 30 minutes, 3 times a week and continuously progress their program. In addition they will every month receive an email with general falls prevention information in a short video. Receives: Behavioral: Safe Step - digital exercise program |
| Control group | Other | During 1 year, the participants randomized to the control group will receive an email every month with general falls prevention information in a short video. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall rate
Falls will be registered every month through a short digital survey, received by email, asking the participant if they had any falls during the last month. If answering yes a few additional questions about when the fall occurred, any resulting injuries and hospital visits will be asked.
Measured: 12 months
Secondary outcomes (19)
Functional leg strength
Self-administered chair stand test (i.e. number of stands during 30 seconds).
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Perceived Exertion
The Borg Scale of Perceived Exertion during the 30 second chair stand test, rated on a scale between 6 (none) to 20 (maximal exertion).
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated balance
Answering the question: "How do you perceive you balance?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated leg-strength
Answering the question: "How do you perceive your leg muscle strength?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Falls efficacy
Falls Efficacy Scale-International (FES-I). Concerns about falling is rated for 16 activities (e.g. cleaning the house) on a scale from 1 (not at all concerned ) to 4 (very concerned ). Ratings for each of the 16 activities are summed to a total score ranging from 16 (no concern about falling) to maximum 64 (severe concern about falling)
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Health related quality of life
Health related quality of life is assessed by the EuroQol 5 dimension 5 level self-report questionnaire (EQ-5D-5L).
The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a Visual Analogue scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A 1-digit number express the level selected for each dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties. The VAS records the respondent's self-rated health on a vertical, visual analogue scale (ranging from 0-100) with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
.
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Use of the information videos
Answering the question: "Have you watched the videos we sent you by e-mail during the last 3 months?" on a 4-level ordinal scale.
Measured: 3 months, 6 months, 9 months, 12 months
Experienced positive effects of the exercise intervention
Exercise intervention: Self-report of any positive effects of the exercise intervention besides effects on balance and strength. On a nominal scale including an optional text field.
Measured: 3 months, 6 months, 9 months, 12 months
Experienced negative effects of the exercise intervention
Exercise intervention: Self-report of any negative effects (adverse events) of the exercise intervention besides effects on balance and strength. On a nominal scale including an optional text field.
Measured: 3 months, 6 months, 9 months, 12 months
Physical activity
Self-reported minutes/week, pre-defined alternatives in 30 minutes blocks up to more than 2 hours.
Measured: Change: Baseline, 12 months
Number of fallers
Falls will be registered every month through a short digital survey, received by email, asking the participant if they had any falls during the last month. If answering yes a few additional questions about when the fall occurred, any resulting injuries and hospital visits will be asked.
Measured: 12 months
Exercise adherence throughout the intervention
Exercise intervention: Adherence to predefined minutes of 3x30 min/week reported continuously through an integrated exercise diary in the Safe step application and by self-report at follow up assessments.
Measured: 12 months
Self-rated improvements in balance
Answering the question: "If you compare with when you started this study a year ago, how would you assess balance today?" on a 5-level ordinal scale on a 5-level ordinal scale ranging from "much better" to "much worse".
Measured: 12 months
Self-rated improvements in leg-strength
Answering the questions: "If you compare with when you started this study a year ago, how would you assess the muscle strength in your legs today?" on a 5-level ordinal scale ranging from "much better" to "much worse".
Measured: 12 months
Rate of attrition
Drop-outs and with-draws in the study
Measured: 12 months
Sociodemographic characteristics
Reach of recruitment will be assessed based on self-reported sociodemographic characteristics of participants included.
Measured: Baseline
New exercise routines
Participants will be asked if they have started to do any exercises (besides the study intervention) during the intervention period.
Measured: 12 months
Costs related to the interventions
Participants will be asked to report if they have had any cost related to the intervention during the intervention period e.g. for internet access or equipment.
Measured: 12 months
Cost-effectiveness
Cost-effectiveness of the interventions with respect to falls
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start27 Sep 2019
- Primary completion8 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Parallel groups
- Model description
- This is a randomized controlled trial (RCT) comparing a digital exercise program with a control group. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- Marlene Sandlund, Assist. Prof, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963570
- Sponsor's protocol ID
- SafeStepRCT
- Acronym
- SafeStepRCT
- Status last verified
- May 2022
- First submitted
- 15 Apr 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the corresponding author on reasonable request.
Publications
Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of the Safe Step Digital Exercise Program to Prevent Falls in Older Community-Dwelling Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 31;27:e67539. doi: 10.2196/67539.
PubMed 40163860Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial. BMJ Open. 2020 May 17;10(5):e036194. doi: 10.1136/bmjopen-2019-036194.
PubMed 32423936
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People -The Safe Step Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03963570
- Acronym / sponsor ID
- SafeStepRCT / SafeStepRCT
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Prevention and control, Exercise, Exercise therapy/methods*, Aged, Aged 80 and over, Smartphone, Computers handheld
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,628 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Glasgow Caledonian University
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 24 May 2019 (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.
The overall aim of the study is to evaluate the effectiveness of a digital self-management exercise program in preventing falls in community dwelling older people.
Participants will be recruited in Sweden through the website (www.sakrasteg.se) providing study information. On the website interested seniors will get information about the aim and procedures of the study as well as inclusion and exclusion criteria. If seniors themselves judge that they are eligible to participate in the study they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will be randomized to either an exercise intervention or a control group in a 1:1 ratio. The investigators aim to include 1400 participants and recruitment will be ongoing continuously for one year.
The exercise intervention is delivered through the Safe Step application, developed in co-creation with seniors and an interdisciplinary research team. Safe Step provides a large repository of evidence based exercises in video formats alongside falls preventive information and advice. With support of this application the user can compose an individualized exercise program with balance and strength exercises suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application during one year, with a recommendation of 30 minutes at least 3 times/week.
In addition to the exercise intervention the participants will every month get an email with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message. The exercise group will be compared to a control group that will receive the same information emails as the exercise group, but no individual exercise advice.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 month in addition the monthly fall reports. Due to the nature of the study, with no face to face contact, all outcome measures are self-reports and self-tests in digital surveys. The primary outcome is fall rate. The study follows the CONSORT guidelines and CONSORT EHEALTH criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial (RCT) comparing a digital exercise program with a control group. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Safe Step - digital exercise program | Experimental | Behavioral: Safe Step - digital exercise programParticipants randomized to the experimental group will receive full access to the Safe Step application and create their own individual program of strength and balance exercises. During 1 year the participants are recommended to exercise at least 30 minutes, 3 times a week and continuously progress their program. In addition they will every month receive an email with general falls prevention information in a short video. |
| Control group | Other | Behavioral: Control groupDuring 1 year, the participants randomized to the control group will receive an email every month with general falls prevention information in a short video. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 70 years or older
- Have fallen or experienced a decline in perceived postural balance during the last year
- Have access to a smartphone or a tablet and uses it regularly
- Have an own email address and uses it
- Ability to understand verbal and written instructions in Swedish
Key exclusion criteria (3 listed)
- Progressive disease where there is likely to be a decline in strength or balance over the next year
- Perceived memory dysfunction that affect everyday life activities
- Taking part in more than 3 hours each week of strenuous physical exercise which makes them out of breath (e.g. dance, gymnastics, gym exercises, running or skiing)
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 |
|---|---|---|
| Safe Step - digital exercise programAfter receiving the Safe Step application the participants view an instruction movie on how to use the application to create and progress their own individual exercise program. The exercises, presented in video format, are organized into 10 predetermined groups with a main focus to improve balance (3 groups), increase lower-limb strength (4 groups), and improve gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises. They can use the app to plan their exercises, set reminders, register their exercise, and view statistics of their progress. A virtual physiotherapist deliver motivational messages and feed-back. At the end of every month, of the 1 year intervention period, the participants will receive an email asking them to report any falls during the past month by answering a short digital survey. This message will provide a new video each month with general falls prevention information besides exercise. | Behavioural | Safe Step - digital exercise program |
| Control groupParticipants randomized to the control condition will only be given information. They will receive exactly the same email messages as the intervention group with falls prevention information and a request to report any falls. At the end of the 12 month intervention we will, in addition to the other questions, ask if they have started to do any exercises during the intervention period. After the 12 month follow-up assessment the control group will be offered the Safe Step application. | Behavioural | Control group |
Primary outcome
Fall rate
Time frame: 12 months
Falls will be registered every month through a short digital survey, received by email, asking the participant if they had any falls during the last month. If answering yes a few additional questions about when the fall occurred, any resulting injuries and hospital visits will be asked.
19 secondary outcomes
Functional leg strength
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Perceived Exertion
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated balance
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated leg-strength
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Falls efficacy
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Health related quality of life
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Use of the information videos
Time frame: 3 months, 6 months, 9 months, 12 months
Experienced positive effects of the exercise intervention
Time frame: 3 months, 6 months, 9 months, 12 months
Experienced negative effects of the exercise intervention
Time frame: 3 months, 6 months, 9 months, 12 months
Physical activity
Time frame: Change: Baseline, 12 months
Number of fallers
Time frame: 12 months
Exercise adherence throughout the intervention
Time frame: 12 months
Self-rated improvements in balance
Time frame: 12 months
Self-rated improvements in leg-strength
Time frame: 12 months
Rate of attrition
Time frame: 12 months
Sociodemographic characteristics
Time frame: Baseline
New exercise routines
Time frame: 12 months
Costs related to the interventions
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
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 23 May 2022.
- Derived from this study: PubMed 40163860Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of the Safe Step Digital Exercise Program to Prevent Falls in Older Community-Dwelling Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 31;27:e67539. doi: 10.2196/67539.
- Derived from this study: PubMed 32423936Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial. BMJ Open. 2020 May 17;10(5):e036194. doi: 10.1136/bmjopen-2019-036194.
- Project web-siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available from the corresponding author on reasonable request.
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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.
Marlene Sandlund, Assist. Prof principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Step - digital exercise program in people with Accidental Falls, run by Umeå University at 1 site in Sweden.
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 7 inclusion and 3 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 23 May 2022. 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 Sweden. 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?
Fall rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963570, which also lists 2 linked publications.
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 23 May 2022.