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Falls Prevention in Older Home Care Recipients

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ClinicalTrials.gov Identifier: NCT02374307
Recruitment Status : Completed
First Posted : February 27, 2015
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Bjerk, Oslo Metropolitan University

Brief Summary:
The aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. Participants in the intervention group perform the Otago exercise programme. Participants in the control group continue their usual activities.

Condition or disease Intervention/treatment Phase
Accidental Falls Other: Exercise and education Not Applicable

Detailed Description:
Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. This randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and education
This group performs a 12-week individual tailored home exercise programme in accordance with the manual of Otago exercise programme. Physiotherapists visit the participants 5 times during the 12 weeks (at week 1,2,4,8 and 10) to prescribe and progress exercises. Motivational conversations on telephone are performed the weeks when no visits are scheduled. Additionally, the participants receive information on the first visit which will focus on motivation, importance of adherence and effectiveness of falls prevention. The participants are expected to do exercises on their own, and in that way perform exercises 3 times weekly. If safe, the participant are provided with a walking plan and be encouraged to walk twice weekly.
Other: Exercise and education
Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.

No Intervention: Control
The control group performs activities as usual.



Primary Outcome Measures :
  1. Short Form 36 Health Survey Summary Scores [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in the Short Form 36 Health Survey (SF-36) summary scores from baseline to 3-months follow-up. SF-36 measures health-related quality of life. Its summary score is comprised of a physical component summary (PCS) and a mental component summary (MCS). The scores range from 0-100 (worst-best) in each scale. A positive change in the summary score indicates a better health-related quality of life.


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in the EuroQOL EQ-5D instrument indicating changes in health-related quality of life. Preference weights for United Kingdom were employed to generate utility scores ranging from -0.59 to 1. A score of 1 is associated with a health state without problems. A positive change in EQ-5D indicates a better health-related quality of life.

  2. Berg Balance Scale [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in the Berg Balance Scale (BBS), a 14-item scale applied to assess static and dynamic balance in older adults. The summary score ranges from 0 (low, wheelchair bound) to 56 (high, independent)

  3. Sit-to-stand Test [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in the no. of raises in 30 seconds. From the sitting position, the subject stands completely up, then sits completely back down, repeated for 30 seconds.

  4. 4-meter Walk Test [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in the 4-meter walk test. Participants are asked to walk a distance of 4 meters at their usual pace, measured in m/s

  5. Falls Efficacy Scale - International [ Time Frame: Baseline, 3 months, 6 months ]
    Changes in falls-efficacy measured with the Falls Efficacy Scale - International (FES-I) derives from a self-report questionnaire, assessing concerns about falling in 16 different daily activities. The total score ranges from 16 (no concern) to 64 (high concern). A decrease in scores indicates less concerns.

  6. Instrumental Activities of Daily Living [ Time Frame: Baseline, 3-months, 6-months ]
    No. of participants with scores on the Instrumental Activities of Daily Living (IADL) scale, Lawton and Brody. IADL is a measure of a person's self-reported ability to perform complex activities of daily living. The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).

  7. Walking Habits [ Time Frame: Baseline, 3 months, 6 months ]
    Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.

  8. Mini Nutritional Assessment [ Time Frame: Baseline, 3 months, 6 months ]
    The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses "Normal nutritional status", "Risk of malnutrition" and being "Malnourished".

  9. Exercise According to the Protocol. Adherence [ Time Frame: Baseline and 3 months ]
    No. of participants in the intervention group performing exercises according to the protocol in the intervention period until 3-months follow-up. Participant are encouraged to complete an activity diary where they note if the exercise programme has been executed as planned. If they have not completed sufficient exercises, they are supposed to make a note in the diary.

  10. No. of Participants Exercising Post-intervention [ Time Frame: 3 months and 6 months ]
    Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.

  11. No. of Falls [ Time Frame: 3 months and 6 months ]
    No. of falls in the post-intervention period between 3-months follow-up and 6-months follow-up. Falls are defined as an event, i.e. fall, trip, slip, which results in the person coming to rest on the ground or floor or other lower level.



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Ages Eligible for Study:   67 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has fallen at least one time in the last 12 months
  • receives home-help services
  • able to walk independently indoors with or without walking aid

Exclusion Criteria:

  • medical contraindication to exercise
  • life expectancy <1 year
  • scores under 23 points on Mini Mental Scale Examination
  • participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

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): NCT02374307


Locations
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Norway
Municipality of Frogn
Drøbak, Akershus, Norway
Municipality of Rælingen
Fjerdingby, Akershus, Norway
Municipality of Skedsmo
Lillestrøm, Akershus, Norway
Municipality of Lørenskog
Lørenskog, Akershus, Norway
Municipality of Bærum
Sandvika, Akershus, Norway
Municipality of Sørum
Sørumsand, Akershus, Norway
Sponsors and Collaborators
Oslo Metropolitan University
Investigators
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Study Director: Astrid Bergland, PhD OsloMet - Oslo Metropolitan University
Principal Investigator: Maria Bjerk, MSc OsloMet - Oslo Metropolitan University
  Study Documents (Full-Text)

Documents provided by Maria Bjerk, Oslo Metropolitan University:
Publications of Results:
Other Publications:

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Responsible Party: Maria Bjerk, PhD Research Fellow, Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT02374307    
Other Study ID Numbers: 130140
2014/2051 ( Other Identifier: Regional Ethics Committees Norway )
First Posted: February 27, 2015    Key Record Dates
Results First Posted: November 14, 2019
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The raw data collected in this project is only available to the participating researchers due to risk to confidentiality of participants and Norwegian data protection laws. An anonymized subset of the raw data, where direct and potentially indirect person identifiers are removed, is planned to be made available in a public data repository after the project is finished and main results are published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Bjerk, Oslo Metropolitan University:
Falls
Home care
Older people
Falls prevention
Quality of life
Exercise
Balance
Preventative care
Community health services
Home-help services