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

Umeå University

Status: Completed

Conditions: Accidental Falls

Treatments: Behavioral: Safe Step - digital exercise program; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03963570

SafeStepRCT

Details and patient eligibility

About

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.

Enrollment: 1,628 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,628 participants in 2 patient groups

Safe Step - digital exercise program

Experimental group

Description:

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.

Treatment:

Behavioral: Safe Step - digital exercise program

Control group

Other group

Description:

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.

Treatment:

Behavioral: Control group