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Completed

NCT Number: NCT02916849

A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises 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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caring Science Buildning, Umeå University

Umeå, 90187, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safe Step

Other

Strength and balance exercise-digital version

OEP

Other

Strength and balance exercise -paper version

Primary outcomes

  1. Adherence

    Time frame: after 4 month

    adherence to the program from baseline to four months

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Forte
  • Glasgow Caledonian University
  • The Swedish Research Council

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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