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

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ClinicalTrials.gov Identifier: NCT02916849
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
The Swedish Research Council
FORTE
Glasgow Caledonian University
Information provided by (Responsible Party):
Marlene Sandlund, Umeå University

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.


Condition or disease Intervention/treatment Phase
Accidental Falls Other: Safe Step Other: OEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adherence [ Time Frame: after 4 month ]
    adherence to the program from baseline to four months


Secondary Outcome Measures :
  1. Change: Attitudes to Falls-Related Interventions Scale (AFRIS) [ Time Frame: baseline, two month and four month ]
  2. Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2) [ Time Frame: baseline, two month and four month ]
  3. Change: Iconographical Falls Efficacy Scale (Icon-FES) [ Time Frame: baseline and four month ]
    Participants' falls-efficacy in certain situations

  4. Change: Activity Specific Balance Confidence Scale (ABC) [ Time Frame: baseline and four month ]
    Participants' falls-efficacy in certain situations

  5. Change: Late-Life Function and Disability Instrument (LLFDI) [ Time Frame: baseline and four month ]
    a person's ability to do discrete actions or activities, and disability-a person's performance of socially defined life tasks

  6. Change: Short Physical Performance Battery [ Time Frame: baseline and four month ]
    Standing balance, leg muscle strength in chair stand, and gait speed

  7. Change: 30 second chair-stand [ Time Frame: baseline and four month ]
    Leg muscle strength in chair stand

  8. Usability of the programs [ Time Frame: Up to four months ]
    Interviews and observations

  9. Uptake [ Time Frame: baseline ]
    Proportion of invited participants that accepted and started the program.


Other Outcome Measures:
  1. Background data [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916849


Locations
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Sweden
Caring Science Buildning, Umeå University
Umeå, Sweden, 90187
Sponsors and Collaborators
Umeå University
The Swedish Research Council
FORTE
Glasgow Caledonian University
Investigators
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Principal Investigator: Marlene Sandlund, Ass. Prof. Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn

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Responsible Party: Marlene Sandlund, Assistant Professor, Umeå University
ClinicalTrials.gov Identifier: NCT02916849     History of Changes
Other Study ID Numbers: SafeStep
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact the author. Data will be kept for 10 years after trial finishes.
Keywords provided by Marlene Sandlund, Umeå University:
Accidental Falls
Prevention & Control
Exercise
Exercise therapy/methods*
Aged
Aged 80 and over
Smartphone
Computers
Computers handheld
Motivation
Postural balance
Health behaviour
mHealth
eHealth