NCT02916849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

December 15, 2017

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 13, 2016

Last Update Submit

December 14, 2017

Conditions

Accidental Falls

Keywords

Accidental FallsPrevention & ControlExerciseExercise therapy/methods*AgedAged 80 and overSmartphoneComputersComputers handheldMotivationPostural balanceHealth behaviourmHealtheHealth

Outcome Measures

Primary Outcomes (1)

  • Adherence

    adherence to the program from baseline to four months

    after 4 month

Secondary Outcomes (9)

  • 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)

    baseline and four month

  • Change: Activity Specific Balance Confidence Scale (ABC)

    baseline and four month

  • Change: Late-Life Function and Disability Instrument (LLFDI)

    baseline and four month

  • +4 more secondary outcomes

Other Outcomes (1)

  • Background data

    Baseline

Study Arms (5)

Safe Step - Health Care Centre

EXPERIMENTAL

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

OEP - Health Care Centre

ACTIVE COMPARATOR

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

Safe Step - Advertising

EXPERIMENTAL

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

Safe Step mentors- Advertising

EXPERIMENTAL

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

OEP - Advertising

ACTIVE COMPARATOR

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

Interventions

Safe StepOTHER

Strength and balance exercise-digital version

Safe Step - AdvertisingSafe Step - Health Care CentreSafe Step mentors- Advertising
OEPOTHER

Strength and balance exercise -paper version

OEP - AdvertisingOEP - Health Care Centre

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Independently living
  • Able to rise from a high chair
  • Able to stand without support
  • Experience an impaired balance

You may not qualify if:

  • Progressive disease that impairs mobility
  • Dementia diagnosis
  • Intense exercising more than 3 hours / week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caring Science Buildning, Umeå University

Umeå, 90187, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 34328438DERIVED

  • 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.

    PMID: 32539711DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marlene Sandlund, Ass. Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

December 15, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Contact the author. Data will be kept for 10 years after trial finishes.

Locations

SE(1)