Accidental FallsNCT02916849
A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People
A study testing Safe Step and OEP in people with Accidental Falls, run by Umeå University at 1 site in Sweden.
Trial summary
This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Safe Step and OEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to 31 Mar 2017
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Independently living
- Able to rise from a high chair
- Able to stand without support
- Experience an impaired balance
Who cannot join
- Progressive disease that impairs mobility
- Dementia diagnosis
- Intense exercising more than 3 hours / week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People
This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability and ability to detect change of possible outcome measurements will be evaluated before a future randomized controlled trial. A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology based exercise program with motivational strategies, developed by researchers in collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises presented in a booklet. The older participants will be free to select either of the intervention programs and the selection process and outcome will be studied as part of the process evaluation.
The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be recruited through advertisements in local papers and through posters and meetings at senior citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants will be recruited from health care centres and their registered professionals with experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10 participants in each, will be exercising for four months and will undergo testing at baseline, after two and four months and they will be asked to keep an exercise diary (digital or paper format) during the intervention.
- Conditions
- Accidental Falls
- Being tested
- Safe Step, OEP
- Keywords
- Accidental Falls, Prevention & Control, Exercise, Exercise therapy/methods*, Aged, Aged 80 and over, Smartphone, Computers, Computers handheld, Motivation, Postural balance, Health behaviour, mHealth, eHealth
- 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 StepOther
Strength and balance exercise-digital version
OEPOther
Strength and balance exercise -paper version
| Study group | Role | What they receive |
|---|---|---|
| Safe Step - Health Care Centre | Experimental | Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Safe Step exercise program as intervention, participants will be given a green prescription for exercise using the application Safe Step. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. Receives: Other: Safe Step |
| OEP - Health Care Centre | Active comparator | Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Otago Exercise Program as intervention in the study participants will be given a green prescription for exercise with the Otago Home Exercise Programme-booklet. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. Receives: Other: OEP |
| Safe Step - Advertising | Experimental | Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the Safe Step application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time Receives: Other: Safe Step |
| Safe Step mentors- Advertising | Experimental | This arm is exactly the same as the Safe Step Advertising group except the participants will be invited to attend group meetings with peer mentors, once a month during the intervention. The peer mentors are older adults earlier involved in the research project . They will act as role models and encourage the participants throughout the four months of exercise. Receives: Other: Safe Step |
| OEP - Advertising | Active comparator | Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the Otago booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. Receives: Other: OEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
adherence to the program from baseline to four months
Measured: after 4 month
Secondary outcomes (9)
Change: Attitudes to Falls-Related Interventions Scale (AFRIS)
Measured: baseline, two month and four month
Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2)
Measured: baseline, two month and four month
Change: Iconographical Falls Efficacy Scale (Icon-FES)
Participants' falls-efficacy in certain situations
Measured: baseline and four month
Change: Activity Specific Balance Confidence Scale (ABC)
Participants' falls-efficacy in certain situations
Measured: baseline and four month
Change: Late-Life Function and Disability Instrument (LLFDI)
a person's ability to do discrete actions or activities, and disability-a person's performance of socially defined life tasks
Measured: baseline and four month
Change: Short Physical Performance Battery
Standing balance, leg muscle strength in chair stand, and gait speed
Measured: baseline and four month
Change: 30 second chair-stand
Leg muscle strength in chair stand
Measured: baseline and four month
Usability of the programs
Interviews and observations
Measured: Up to four months
Uptake
Proportion of invited participants that accepted and started the program.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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.
- More trials run by Umeå UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Forte, Glasgow Caledonian University
- Responsible party
- Principal investigator, Marlene Sandlund, Umeå University
- Investigators
- Marlene Sandlund, Ass. Prof., Principal investigator, Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916849
- Sponsor's protocol ID
- SafeStep
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Contact the author. Data will be kept for 10 years after trial finishes.
Publications
Pettersson B, Janols R, Wiklund M, Lundin-Olsson L, Sandlund M. Older Adults' Experiences of Behavior Change Support in a Digital Fall Prevention Exercise Program: Qualitative Study Framed by the Self-determination Theory. J Med Internet Res. 2021 Jul 30;23(7):e26235. doi: 10.2196/26235.
PubMed 34328438Mansson L, Lundin-Olsson L, Skelton DA, Janols R, Lindgren H, Rosendahl E, Sandlund M. Older adults' preferences for, adherence to and experiences of two self-management falls prevention home exercise programmes: a comparison between a digital programme and a paper booklet. BMC Geriatr. 2020 Jun 15;20(1):209. doi: 10.1186/s12877-020-01592-x.
PubMed 32539711
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People
- ClinicalTrials.gov ID
- NCT02916849
- Acronym / sponsor ID
- SafeStep
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, Prevention & Control, Exercise, Exercise therapy/methods*, Aged, Aged 80 and over, Smartphone, Computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Forte, Glasgow Caledonian University
- Study start
- Sep 2016
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 28 Sep 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.
This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability and ability to detect change of possible outcome measurements will be evaluated before a future randomized controlled trial. A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology based exercise program with motivational strategies, developed by researchers in collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises presented in a booklet. The older participants will be free to select either of the intervention programs and the selection process and outcome will be studied as part of the process evaluation.
The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be recruited through advertisements in local papers and through posters and meetings at senior citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants will be recruited from health care centres and their registered professionals with experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10 participants in each, will be exercising for four months and will undergo testing at baseline, after two and four months and they will be asked to keep an exercise diary (digital or paper format) during the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Safe Step - Health Care Centre | Experimental | Other: Safe StepParticipants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Safe Step exercise program as intervention, participants will be given a green prescription for exercise using the application Safe Step. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. |
| OEP - Health Care Centre | Active comparator | Other: OEPParticipants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Otago Exercise Program as intervention in the study participants will be given a green prescription for exercise with the Otago Home Exercise Programme-booklet. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. |
| Safe Step - Advertising | Experimental | Other: Safe StepParticipants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the Safe Step application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time |
| Safe Step mentors- Advertising | Experimental | Other: Safe StepThis arm is exactly the same as the Safe Step Advertising group except the participants will be invited to attend group meetings with peer mentors, once a month during the intervention. The peer mentors are older adults earlier involved in the research project . They will act as role models and encourage the participants throughout the four months of exercise. |
| OEP - Advertising | Active comparator | Other: OEPParticipants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the Otago booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Independently living
- Able to rise from a high chair
- Able to stand without support
- Experience an impaired balance
Key exclusion criteria (3 listed)
- Progressive disease that impairs mobility
- Dementia diagnosis
- Intense exercising more than 3 hours / week
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 StepStrength and balance exercise-digital version | Other | Safe Step - Advertising, Safe Step - Health Care Centre, Safe Step mentors- Advertising |
| OEPStrength and balance exercise -paper version | Other | OEP - Advertising, OEP - Health Care Centre |
Primary outcome
Adherence
Time frame: after 4 month
adherence to the program from baseline to four months
9 secondary outcomes
Change: Attitudes to Falls-Related Interventions Scale (AFRIS)
Time frame: baseline, two month and four month
Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2)
Time frame: baseline, two month and four month
Change: Iconographical Falls Efficacy Scale (Icon-FES)
Time frame: baseline and four month
Change: Activity Specific Balance Confidence Scale (ABC)
Time frame: baseline and four month
Change: Late-Life Function and Disability Instrument (LLFDI)
Time frame: baseline and four month
Change: Short Physical Performance Battery
Time frame: baseline and four month
Change: 30 second chair-stand
Time frame: baseline and four month
Usability of the programs
Time frame: Up to four months
Uptake
Time frame: baseline
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 15 Dec 2017.
- Derived from this study: PubMed 34328438Pettersson B, Janols R, Wiklund M, Lundin-Olsson L, Sandlund M. Older Adults' Experiences of Behavior Change Support in a Digital Fall Prevention Exercise Program: Qualitative Study Framed by the Self-determination Theory. J Med Internet Res. 2021 Jul 30;23(7):e26235. doi: 10.2196/26235.
- Derived from this study: PubMed 32539711Mansson L, Lundin-Olsson L, Skelton DA, Janols R, Lindgren H, Rosendahl E, Sandlund M. Older adults' preferences for, adherence to and experiences of two self-management falls prevention home exercise programmes: a comparison between a digital programme and a paper booklet. BMC Geriatr. 2020 Jun 15;20(1):209. doi: 10.1186/s12877-020-01592-x.
- Individual participant dataSharing planned: Yes. Contact the author. Data will be kept for 10 years after trial finishes.
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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, Ass. Prof. principal investigator
Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn
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 and OEP 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 4 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 15 Dec 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 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?
Adherence (time frame: after 4 month). 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 NCT02916849, 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 15 Dec 2017.