The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People

Accidental Falls Clinical Trial

— SafeStepRCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963570
• Other study ID #: SafeStepRCT
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: May 5, 2022

Study information

• Verified date: May 2022
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1628
• Est. completion date: May 5, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• Safe Step - digital exercise program
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 group
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.

Locations

Country	Name	City	State
Sweden	Caring Science Buildning, Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Glasgow Caledonian University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Functional leg strength	Self-administered chair stand test (i.e. number of stands during 30 seconds).	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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).	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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".	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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".	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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)	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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".; .	Change; Baseline, 3 months, 6 months, 9 months, 12 months
Secondary	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.	3 months, 6 months, 9 months, 12 months
Secondary	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.	3 months, 6 months, 9 months, 12 months
Secondary	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.	3 months, 6 months, 9 months, 12 months
Secondary	Physical activity	Self-reported minutes/week, pre-defined alternatives in 30 minutes blocks up to more than 2 hours.	Change: Baseline, 12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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".	12 months
Secondary	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".	12 months
Secondary	Rate of attrition	Drop-outs and with-draws in the study	12 months
Secondary	Sociodemographic characteristics	Reach of recruitment will be assessed based on self-reported sociodemographic characteristics of participants included.	Baseline
Secondary	New exercise routines	Participants will be asked if they have started to do any exercises (besides the study intervention) during the intervention period.	12 months
Secondary	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.	12 months
Secondary	Cost-effectiveness	Cost-effectiveness of the interventions with respect to falls	12 months

External Links

•   Project web-site