NCT03963570

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,628 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Accidental Falls

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-09-27
• Primary completion: 2022-04-08
• Completion: 2022-05-05
• First posted: 2019-05-24
• Last updated: 2022-05-23

Locations

1 site across 1 country: Sweden