Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date December 15, 2017
Study Start Date  ICMJE September 2016
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Adherence [ Time Frame: after 4 month ]
adherence to the program from baseline to four months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02916849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Change: Attitudes to Falls-Related Interventions Scale (AFRIS) [ Time Frame: baseline, two month and four month ]
  • Change: Behavioural Regulation In Exercise Questionnaire (BREQ-2) [ Time Frame: baseline, two month and four month ]
  • Change: Iconographical Falls Efficacy Scale (Icon-FES) [ Time Frame: baseline and four month ]
    Participants' falls-efficacy in certain situations
  • Change: Activity Specific Balance Confidence Scale (ABC) [ Time Frame: baseline and four month ]
    Participants' falls-efficacy in certain situations
  • 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
  • Change: Short Physical Performance Battery [ Time Frame: baseline and four month ]
    Standing balance, leg muscle strength in chair stand, and gait speed
  • Change: 30 second chair-stand [ Time Frame: baseline and four month ]
    Leg muscle strength in chair stand
  • Usability of the programs [ Time Frame: Up to four months ]
    Interviews and observations
  • Uptake [ Time Frame: baseline ]
    Proportion of invited participants that accepted and started the program.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People
Official Title  ICMJE A Feasibility Study of an Intervention Using a Mobile Application to Promote Strength and Balance and Reduce Risk of Falls in Older People
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Accidental Falls
Intervention  ICMJE
  • Other: Safe Step
    Strength and balance exercise-digital version
  • Other: OEP
    Strength and balance exercise -paper version
Study Arms  ICMJE
  • 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.
    Intervention: Other: Safe Step
  • 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.
    Intervention: Other: OEP
  • 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
    Intervention: Other: Safe Step
  • 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.
    Intervention: Other: Safe Step
  • 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.
    Intervention: Other: OEP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2017)
69
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
90
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916849
Other Study ID Numbers  ICMJE SafeStep
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Contact the author. Data will be kept for 10 years after trial finishes.
Responsible Party Marlene Sandlund, Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE
  • The Swedish Research Council
  • FORTE
  • Glasgow Caledonian University
Investigators  ICMJE
Principal Investigator: Marlene Sandlund, Ass. Prof. Department of Community Medicin and Rehabilitation, 90187 Umeå University, Swewn
PRS Account Umeå University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP