Completed

SafeStepRCTThe Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People -The Safe Step Randomized Controlled Trial

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What is being tested

Safe Step - digital exercise program

+ Control group

Behavioral
Who is being recruted

Behavior

+ Motor Activity

Over 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorUmeå University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 27, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleThe Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People -The Safe Step Randomized Controlled Trial
NCT03963570
Principal SponsorUmeå University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1628 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMotor Activity

Criteria

7 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Caring Science Buildning, Umeå University

Umeå, SwedenOpen Caring Science Buildning, Umeå University in Google Maps
CompletedOne Study Center