Falls Prevention in Older Home Care Recipients

November 11, 2019 updated by: Maria Bjerk, Oslo Metropolitan University

Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Drøbak, Akershus, Norway
        • Municipality of Frogn
      • Fjerdingby, Akershus, Norway
        • Municipality of Rælingen
      • Lillestrøm, Akershus, Norway
        • Municipality of Skedsmo
      • Lørenskog, Akershus, Norway
        • Municipality of Lørenskog
      • Sandvika, Akershus, Norway
        • Municipality of Bærum
      • Sørumsand, Akershus, Norway
        • Municipality of Sørum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

67 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months
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)
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
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
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months
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).
Baseline, 3-months, 6-months
Walking Habits
Time Frame: Baseline, 3 months, 6 months
Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.
Baseline, 3 months, 6 months
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".
Baseline, 3 months, 6 months
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.
Baseline and 3 months
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.
3 months and 6 months
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.
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo Metropolitan University

Investigators

  • Study Director: Astrid Bergland, PhD, OsloMet - Oslo Metropolitan University
  • Principal Investigator: Maria Bjerk, MSc, OsloMet - Oslo Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130140
  • 2014/2051 (Other Identifier: Regional Ethics Committees Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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