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

NCT03963570 | Completed

• 1 other identifier: SafeStepRCT
• Study Type: interventional
• Target: 1,628
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Accidental Falls; Prevention and control; Exercise; Exercise therapy/methods*; Aged; Aged 80 and over; Smartphone; Computers handheld; Motivation; Behaviour change; Postural balance; Health behaviour; mHealth; eHealth; Digital health; Self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Functional leg strength

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

• Perceived Exertion

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

• Self-rated balance

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

• Self-rated leg-strength

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

• Falls efficacy

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Safe Step - digital exercise program

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.

Behavioral: Safe Step - digital exercise program

Control group

OTHER

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.

Behavioral: Control group

Interventions

Safe Step - digital exercise program BEHAVIORAL

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.

Safe Step - digital exercise program

Control group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umeå University: lead
• Glasgow Caledonian University: collaborator

Study Sites (1)

Caring Science Buildning, Umeå University

Umeå, 90187, Sweden

Location

Related Publications (2)

• Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of the Safe Step Digital Exercise Program to Prevent Falls in Older Community-Dwelling Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 31;27:e67539. doi: 10.2196/67539.

  PMID: 40163860 DERIVED

• Pettersson B, Lundin-Olsson L, Skelton DA, Liv P, Zingmark M, Rosendahl E, Sandlund M. Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial. BMJ Open. 2020 May 17;10(5):e036194. doi: 10.1136/bmjopen-2019-036194.

  PMID: 32423936 DERIVED

Related Links

• Project web-site

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marlene Sandlund, Assist. Prof

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All outcomes are self-reports and self-assessments by the participants and reported in digital surveys. Outcomes will not be influenced by any other outcome assessors. Data set will be blinded regarding group allocation (and the code for the groups will be held by a researcher not involved in the study) when performing analyses for main outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial (RCT) comparing a digital exercise program with a control group. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 24, 2019
• Study Start: September 27, 2019
• Primary Completion: April 8, 2022
• Study Completion: May 5, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be published October-November 2019
• Access Criteria: Data will be available from the corresponding author on reasonable request. The protocol will be published in an open access journal.

Locations

SE (1)