A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People

Study Overview
=================
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.

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

Conditions
-----------------
Accidental Falls

Intervention / Treatment
-----------------
* Other: Safe Step
* Other: OEP


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safe Step - Health Care Centre<br>Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Safe Step exercise program as intervention, participants will be given a green prescription for exercise using the application Safe Step. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. | Other: Safe Step<br>* Strength and balance exercise-digital version<br>|
| Active Comparator: OEP - Health Care Centre<br>Participants will be recruited informed and asked for participation in the study by health care professionals. If included in the study, and choosing the Otago Exercise Program as intervention in the study participants will be given a green prescription for exercise with the Otago Home Exercise Programme-booklet. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. | Other: OEP<br>* Strength and balance exercise -paper version<br>|
| Experimental: Safe Step - Advertising<br>Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises in the Safe Step application. During the four month intervention the participants will create weekly exercise plan, keep a digital exercise diary, and receive motivational feed-back within the system. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time | Other: Safe Step<br>* Strength and balance exercise-digital version<br>|
| Experimental: Safe Step mentors- Advertising<br>This arm is exactly the same as the Safe Step Advertising group except the participants will be invited to attend group meetings with peer mentors, once a month during the intervention. The peer mentors are older adults earlier involved in the research project . They will act as role models and encourage the participants throughout the four months of exercise. | Other: Safe Step<br>* Strength and balance exercise-digital version<br>|
| Active Comparator: OEP - Advertising<br>Participants are recruited through meetings at senior citizens organisations and interviewed by telephone for background data and choice of intervention before inclusion. After an introduction meeting in small groups and pre-assessments the participants will create an individual exercise programme containing ten balance and leg strengthening exercises using the Otago booklet for guidance. During the four month intervention the participants will keep a paper-based exercise diary that will be sent to the researchers on a monthly basis. The participants will be recommended to exercise at least three times per week and for at least 30 minutes at a time. | Other: OEP<br>* Strength and balance exercise -paper version<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | adherence to the program from baseline to four months | after 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change: Attitudes to Falls-Related Interventions Scale (AFRIS) |  | baseline, two month and four month | 
| Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2) |  | baseline, two month and four month | 
| Change: Iconographical Falls Efficacy Scale (Icon-FES) | Participants' falls-efficacy in certain situations | baseline and four month | 
| Change: Activity Specific Balance Confidence Scale (ABC) | Participants' falls-efficacy in certain situations | baseline and four month | 
| 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 | 
| Change: Short Physical Performance Battery | Standing balance, leg muscle strength in chair stand, and gait speed | baseline and four month | 
| Change: 30 second chair-stand | Leg muscle strength in chair stand | baseline and four month | 
| Usability of the programs | Interviews and observations | Up to four months | 
| Uptake | Proportion of invited participants that accepted and started the program. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accidental Falls, Prevention & Control, Exercise, Exercise therapy/methods*, Aged, Aged 80 and over, Smartphone, Computers, Computers handheld, Motivation, Postural balance, Health behaviour, mHealth, eHealth