Accidental Falls Clinical Trial
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
Verified date | September 2016 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Caring Science Buildning, Umeå University | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | FORTE, Glasgow Caledonian University, The Swedish Research Council |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Background data | Before the study the participants will fill in a questionnaire with background data containing: self-reported health, medical diagnoses, medication, age, sex, earlier work, computer skill and number of falls previous year. | Baseline | |
Primary | Adherence | adherence to the program from baseline to four months | after 4 month | |
Secondary | Change: Attitudes to Falls-Related Interventions Scale (AFRIS) | baseline, two month and four month | ||
Secondary | Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2) | baseline, two month and four month | ||
Secondary | Change: Iconographical Falls Efficacy Scale (Icon-FES) | Participants' falls-efficacy in certain situations | baseline and four month | |
Secondary | Change: Activity Specific Balance Confidence Scale (ABC) | Participants' falls-efficacy in certain situations | baseline and four month | |
Secondary | Change: Late-Life Function and Disability Instrument (LLFDI) | a person's ability to do discrete actions or activities, and disability-a person's performance of socially defined life tasks | baseline and four month | |
Secondary | Change: Short Physical Performance Battery | Standing balance, leg muscle strength in chair stand, and gait speed | baseline and four month | |
Secondary | Change: 30 second chair-stand | Leg muscle strength in chair stand | baseline and four month | |
Secondary | Usability of the programs | Interviews and observations | Up to four months | |
Secondary | Uptake | Proportion of invited participants that accepted and started the program. | baseline |
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