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
|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 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|
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.
- 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.
- 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.
- 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)
- 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-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
- 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.
- 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).
- Walking Habits [ Time Frame: Baseline, 3 months, 6 months ]Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.
- 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".
- 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.
- 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.
- 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.
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||OsloMet - Oslo Metropolitan University|
|Principal Investigator:||Maria Bjerk, MSc||OsloMet - Oslo Metropolitan University|