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

NCT ID: NCT02916849

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Accidental Falls

Keywords

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Accidental Falls Prevention & Control Exercise Exercise therapy/methods* Aged Aged 80 and over Smartphone Computers Computers handheld Motivation Postural balance Health behaviour mHealth eHealth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Safe Step

Intervention Type OTHER

Strength and balance exercise-digital version

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.

Group Type ACTIVE_COMPARATOR

OEP

Intervention Type OTHER

Strength and balance exercise -paper version

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

Group Type EXPERIMENTAL

Safe Step

Intervention Type OTHER

Strength and balance exercise-digital version

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.

Group Type EXPERIMENTAL

Safe Step

Intervention Type OTHER

Strength and balance exercise-digital version

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.

Group Type ACTIVE_COMPARATOR

OEP

Intervention Type OTHER

Strength and balance exercise -paper version

Interventions

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Safe Step

Strength and balance exercise-digital version

Intervention Type OTHER

OEP

Strength and balance exercise -paper version

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Forte

INDUSTRY

Sponsor Role collaborator

Glasgow Caledonian University

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Marlene Sandlund

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlene Sandlund, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn

Locations

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Caring Science Buildning, Umeå University

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34328438 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32539711 (View on PubMed)

Other Identifiers

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SafeStep

Identifier Type: -

Identifier Source: org_study_id