The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People -The Safe Step Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Accidental Falls
- Sponsor
- Umeå University
- Enrollment
- 1628
- Locations
- 1
- Primary Endpoint
- Fall rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Fall rate
Time Frame: 12 months
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.
Secondary Outcomes
- Health related quality of life(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Use of the information videos(3 months, 6 months, 9 months, 12 months)
- Experienced positive effects of the exercise intervention(3 months, 6 months, 9 months, 12 months)
- Experienced negative effects of the exercise intervention(3 months, 6 months, 9 months, 12 months)
- Physical activity(Change: Baseline, 12 months)
- Number of fallers(12 months)
- Exercise adherence throughout the intervention(12 months)
- Self-rated improvements in balance(12 months)
- Self-rated improvements in leg-strength(12 months)
- Rate of attrition(12 months)
- Sociodemographic characteristics(Baseline)
- New exercise routines(12 months)
- Costs related to the interventions(12 months)
- Cost-effectiveness(12 months)
- 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)