Clinical trial NCT03963570: The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Glasgow Caledonian University
First posted: 2019-05-24
Enrollment: 1628
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fall rate
timeFrame: 12 months
Secondary outcomes:
measure: Functional leg strength
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Perceived Exertion
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Self-rated balance
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Self-rated leg-strength
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Falls efficacy
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Health related quality of life
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Use of the information videos
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Experienced positive effects of the exercise intervention
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Experienced negative effects of the exercise intervention
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Physical activity
timeFrame: Change: Baseline, 12 months
measure: Number of fallers
timeFrame: 12 months
measure: Exercise adherence throughout the intervention
timeFrame: 12 months
measure: Self-rated improvements in balance
timeFrame: 12 months
measure: Self-rated improvements in leg-strength
timeFrame: 12 months
measure: Rate of attrition
timeFrame: 12 months
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: New exercise routines
timeFrame: 12 months
measure: Costs related to the interventions
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Caring Science Buildning, Umeå University
Study officials:
affiliation: Umeå University
name: Marlene Sandlund, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.