Falls-prevention in Older People Receiving Home-help Services
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|ClinicalTrials.gov Identifier: NCT02374307|
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls||Other: Exercise and education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of a Falls-prevention Program on Quality of Life in Older People Receiving Home-help Services. A Randomized Controlled Clinical Trial|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Exercise and education
This group will perform a 12-week individual tailored home exercise programme in accordance with the manual of Otaga exercise programme. Physiotherapist will 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 will be performed the weeks when no visits are scheduled. Additionally, the participants will 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 will be 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 will perform activities as usual.
- Changes in Health-related quality of life [ Time Frame: baseline, 3 months, 6 months and 12 months ]Changes in health-related quality of life will be measured with the SF-36 which is a questionnaire of 36 items. The 36 items are grouped into eight health status scales: physical functioning, role limitations due to physical problems and due to emotional problems, bodily pain, general health perception, vitality, social functioning and mental health.
- Number of falls [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]Falls will be 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, and the participant will be asked: "Have you had any fall including slip or trip in which you lost your balance and landed on the floor or ground or lower level?". This registration will be performed on monthly calendars which will be collected every third month.
- Ability to perform activities of daily living. [ Time Frame: baseline, 3 months and 6 months ]ADL will be registered with Lawton & Brody ADL scales, which are valid and reliable measures of a person's self-reported ability to perform both basic and complex activities of daily living .
- Falls-efficacy (Falls Efficacy Scale-International) [ Time Frame: baseline, 3 months and 6 months ]Falls-efficacy will be measured with the Falls Efficacy Scale-International, a self-report questionnaire of 16 items measuring level of concern about falling during 16 activities of daily living. Minimum score 16, maximum score 64.
- Health- related quality of life measured by the EQ-5D [ Time Frame: baseline, 3 months, 6 months and 12 months ]The EQ-5D-5L is a generic and validated questionnaire. It describes five dimensions of HRQL (mobility, self-care, usual activities, pain/discomfort, anxiety depression) each of which can take one of five responses at five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems).
- Physical activity level (questions regarding walking habits) [ Time Frame: baseline, 3 months and 6 months ]Questions regarding walking habits in the last 7 days.
- Amount of home-help services received [ Time Frame: baseline, 3 months, 6 months, 12 months ]
- Basic nutritional status (Mini Nutritional Assessment) [ Time Frame: baseline, 3 months and 6 months ]The first section of the Mini Nutritional Assessment, containing questions on nutrition and weight and measurement of BMI, will be used.
- 4 meter gait speed [ Time Frame: baseline, 3 months and 6 months ]Participants are asked to walk a distance of 4 meters at their usual pace
- 30 seconds chair stand test [ Time Frame: baseline, 3 months and 6 months ]From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds.
- Adherence to the programme [ Time Frame: 3 months ]Participant will complete an activity diary where they note if the programme has been executed. If they have not completed sufficient exercise they will note why not.
- Berg Balance Scale [ Time Frame: baseline, 3 months and 6 months ]BBS measures static and dynamic balance. It comprises a set of 14 balance related tasks.
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
|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|
|Study Director:||Astrid Bergland, PhD||Oslo and Akershus University College of Applied Sciences|
|Principal Investigator:||Maria Bjerk, MSc||Oslo and Akershus University College of Applied Sciences|