Clinical trial NCT02916849: A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People
Official title: A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Accidental Falls
Prevention & Control
Exercise
Exercise therapy/methods*
Aged
Aged 80 and over
Smartphone
Computers
Computers handheld
Motivation
Postural balance
Health behaviour
mHealth
eHealth
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Forte
name: Glasgow Caledonian University
First posted: 2016-09-28
Enrollment: 69
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This five arm feasibility study aims to promote self-management in strength and balance exercises among community-living older people. The research process, implementation strategies and procedures, acceptability of the exercise programs, perceived benefits of the programs, and the ecological validity, acceptability and ability to detect change of possible outcome measurements will be evaluated before a future randomized controlled trial. A comparison of two exercise programs will be performed; a) Safe Step, a mobile technology based exercise program with motivational strategies, developed by researchers in collaboration with older adults, and b) Otago Exercise Program (OEP), home exercises presented in a booklet. The older participants will be free to select either of the intervention programs and the selection process and outcome will be studied as part of the process evaluation.

The participants in three of the arms (OEP, Safe Step, and Safe Step with mentors) will be recruited through advertisements in local papers and through posters and meetings at senior citizens organisations. In the fourth and fifth arms (OEP and Safe Step) the participants will be recruited from health care centres and their registered professionals with experience of greens prescriptions (Fysisk aktivitet på recept). All five groups, with at least 10 participants in each, will be exercising for four months and will undergo testing at baseline, after two and four months and they will be asked to keep an exercise diary (digital or paper format) during the intervention.


Eligibility criteria: Inclusion Criteria:

* Independently living
* Able to rise from a high chair
* Able to stand without support
* Experience an impaired balance

Exclusion Criteria:

* Progressive disease that impairs mobility
* Dementia diagnosis
* Intense exercising more than 3 hours / week

Primary outcomes:
measure: Adherence
timeFrame: after 4 month
Secondary outcomes:
measure: Change: Attitudes to Falls-Related Interventions Scale (AFRIS)
timeFrame: baseline, two month and four month
measure: Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2)
timeFrame: baseline, two month and four month
measure: Change: Iconographical Falls Efficacy Scale (Icon-FES)
timeFrame: baseline and four month
measure: Change: Activity Specific Balance Confidence Scale (ABC)
timeFrame: baseline and four month
measure: Change: Late-Life Function and Disability Instrument (LLFDI)
timeFrame: baseline and four month
measure: Change: Short Physical Performance Battery
timeFrame: baseline and four month
measure: Change: 30 second chair-stand
timeFrame: baseline and four month
measure: Usability of the programs
timeFrame: Up to four months
measure: Uptake
timeFrame: baseline
Other outcomes:
measure: Background data
timeFrame: Baseline
Locations:
city: Umeå
country: Sweden
facility: Caring Science Buildning, Umeå University
Study officials:
affiliation: Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn
name: Marlene Sandlund, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pettersson B, Janols R, Wiklund M, Lundin-Olsson L, Sandlund M. Older Adults' Experiences of Behavior Change Support in a Digital Fall Prevention Exercise Program: Qualitative Study Framed by the Self-determination Theory. J Med Internet Res. 2021 Jul 30;23(7):e26235. doi: 10.2196/26235.
citation: Mansson L, Lundin-Olsson L, Skelton DA, Janols R, Lindgren H, Rosendahl E, Sandlund M. Older adults' preferences for, adherence to and experiences of two self-management falls prevention home exercise programmes: a comparison between a digital programme and a paper booklet. BMC Geriatr. 2020 Jun 15;20(1):209. doi: 10.1186/s12877-020-01592-x.