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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916849
• Other study ID #: SafeStep
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: December 14, 2017
• Start date: September 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• Safe Step
Strength and balance exercise-digital version
• OEP
Strength and balance exercise -paper version

Locations

Country	Name	City	State
Sweden	Caring Science Buildning, Umeå University	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	FORTE, Glasgow Caledonian University, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

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