Caring Science Buildning, Umeå University
Umeå, 90187, Sweden
NCT Number: NCT04161625
The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial.
Information about the study will be spread to the population by letters sent to all households with someone aged 70 years or older, presentations for senior organizations, advertisements on busses, health care centers, senior centers and in social media. Participants will be recruited in one municipality through the website (www.ostersund.se/sakrasteg) including information about the aim and procedures of the study. 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 get access to the mobile health application. The estimated target group is 2600 persons. Recruitment will be ongoing for six months. The intervention is delivered through the Safe Step application, developed in co-creation with seniors and researchers. Safe Step provides a large repository of evidence-based balance and strength exercises in video formats alongside falls preventive information and advice. With the Safe Step app the user can compose an individualized exercise program 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 for one year, with a recommendation of 30 minutes at least 3 times/week. In addition, participants will get monthly emails 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.
In order to maximize reach and to support participants to get started using the Safe Step application, technical support and group-based exercise will be provided.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 months in addition to the monthly fall reports. Effects and cost effectiveness will be evaluated in relation to a previously registered RCT NCT03963570.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
Umeå, 90187, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.
Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information.
Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis&Svettis)
Time frame: 12 months
The number of participants in relation to estimated size of total target population
Time frame: Baseline
Reach of recruitment will be assessed in relation to age.
Time frame: Baseline
Reach of recruitment will be assessed in relation to gender.
Time frame: Baseline
Reach of recruitment will be assessed in relation to living conditions).
Time frame: [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]
Self-administered chair stand test (i.e. number of stands during 30 seconds).
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
The Borg Scale of Perceived Exertion during the 30 second chair stand test, rated on a scale between 6 (none) to 20 (maximal exertion).
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Answering the question: "How do you perceive you balance?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Answering the question: "How do you perceive your leg muscle strength?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
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)
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
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".
Time frame: 3 months, 6 months, 9 months, 12 months
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.
Time frame: 3 months, 6 months, 9 months, 12 months
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.
Time frame: 3 months, 6 months, 9 months, 12 months
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.
Time frame: Change: Baseline, 12 months
Self-reported minutes/week, pre-defined alternatives in 30 minutes blocks up to more than 2 hours.
Time frame: 12 months
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.
Time frame: 12 months
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".
Time frame: 12 months
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".
Time frame: 12 months
Drop-outs and with-draws in the study
Time frame: 12 months
Participants will be asked if they have started to do any exercises (besides the study intervention) during the intervention period.
Time frame: 12 months
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.
Time frame: 12 months
Cost per falls averted, cost per quality adjusted life years gained.
Time frame: 12 months
Number of participants participating in technical support sessions
Time frame: 12 months
Number of participants participating in try-out group exercise sessions
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.
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.
Umeå University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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