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

A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People

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.

Study Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Other: Safe Step; Other: OEP

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, 90187
    • Caring Science Buildning, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe Step - Health Care Centre; 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; Strength and balance exercise-digital version
Active Comparator: OEP - Health Care Centre; 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; Strength and balance exercise -paper version
Experimental: Safe Step - Advertising; 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; Strength and balance exercise-digital version
Experimental: Safe Step mentors- Advertising; 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; Strength and balance exercise-digital version
Active Comparator: OEP - Advertising; 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; Strength and balance exercise -paper version

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: The Swedish Research Council; Forte; Glasgow Caledonian University
• Investigators: Principal Investigator: Marlene Sandlund, Ass. Prof., Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Motivation; Smartphone; mHealth; eHealth; Prevention & Control; Aged; Accidental Falls; Postural balance; Health behaviour; Exercise therapy/methods*; Aged 80 and over; Computers; Computers handheld
• Other Study ID Numbers: SafeStep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Contact the author. Data will be kept for 10 years after trial finishes.