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| ID | Type | Description | Link |
|---|---|---|---|
| 2014/2051 | Other Identifier | Regional Ethics Committees Norway |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and education | Experimental | 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. |
|
| Control | No Intervention | The control group performs activities as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and education | Other | Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form 36 Health Survey Summary Scores | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Bergland, PhD | OsloMet - Oslo Metropolitan University | Study Director |
| Maria Bjerk, MSc | OsloMet - Oslo Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipality of Frogn | Drøbak | Akershus | Norway | |||
| Municipality of Rælingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10109801 | Background | EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. | |
| 10158943 | Background | Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6. |
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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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167 older adults consented to baseline testing. 12 did not met the inclusion criteria and were not considered enrolled in the study. 155 met the inclusion criteria and were randomized in either the intervention or control group.
The recruitment period was from February 2016 to February 2017. 865 older adults were assessed for eligibility. 320 had experienced a fall and received an invitation letter to participate in this study. Recruitment stopped when the sample size target (150) was expected to be reached.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence. |
| FG001 | Control | Activities as usual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-months Follow-up |
|
| |||||||||||||||||||||
| 6-months Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Form 36 Health Survey Summary Scores | 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. | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | scores on a scale | Baseline, 3 months, 6 months |
|
Study period of 6 months
Adverse events definition also included falls, cardiovascular events or musculoskeletal injuries when performing exercises.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain/discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment | Musculoskeletal pain/discomfort after using ankle cuffs |
Some measurements are self-reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Bjerk | OsloMet - Oslo Metropolitan University | +4767236683 | maria.bjerk@oslomet.no |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2017 | Oct 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Berg Balance Scale | 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 | 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 | 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 | 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 | 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 | Questions regarding walking habits in the last 7 days. Summarized in total minutes walking. | Baseline, 3 months, 6 months |
| Mini Nutritional Assessment | 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 | 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 | Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up. | 3 months and 6 months |
| No. of Falls | 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 |
| 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 |
| 21479777 | Background | Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. |
| 23184421 | Background | Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25. |
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 16267188 | Background | Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196. |
| 8126356 | Background | Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85. |
| 5349366 | Background | Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available. |
| 9990575 | Background | Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3. |
| 20817938 | Background | Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4. |
| 18218822 | Background | Muir SW, Berg K, Chesworth B, Speechley M. Use of the Berg Balance Scale for predicting multiple falls in community-dwelling elderly people: a prospective study. Phys Ther. 2008 Apr;88(4):449-59. doi: 10.2522/ptj.20070251. Epub 2008 Jan 24. |
| 28806904 | Result | Bjerk M, Brovold T, Skelton DA, Bergland A. A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial. BMC Health Serv Res. 2017 Aug 14;17(1):559. doi: 10.1186/s12913-017-2516-5. |
| 30348098 | Result | Bjerk M, Brovold T, Skelton DA, Bergland A. Associations between health-related quality of life, physical function and fear of falling in older fallers receiving home care. BMC Geriatr. 2018 Oct 22;18(1):253. doi: 10.1186/s12877-018-0945-6. |
| 30615055 | Result | Bjerk M, Brovold T, Skelton DA, Liu-Ambrose T, Bergland A. Effects of a falls prevention exercise programme on health-related quality of life in older home care recipients: a randomised controlled trial. Age Ageing. 2019 Mar 1;48(2):213-219. doi: 10.1093/ageing/afy192. |
| 31169888 | Result | Bjerk M, Brovold T, Davis JC, Skelton DA, Bergland A. Health-related quality of life in home care recipients after a falls prevention intervention: a 6-month follow-up. Eur J Public Health. 2020 Feb 1;30(1):64-69. doi: 10.1093/eurpub/ckz106. |
| 31364036 | Result | Bjerk M, Brovold T, Davis JC, Bergland A. Evaluating a falls prevention intervention in older home care recipients: a comparison of SF-6D and EQ-5D. Qual Life Res. 2019 Dec;28(12):3187-3195. doi: 10.1007/s11136-019-02258-x. Epub 2019 Jul 30. |
| Death |
|
| Missed first follow-up |
|
| NOT COMPLETED |
|
|
Activities as usual.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Living alone | If the participant is living alone, e.g. without a spouse or cohabitant. | Count of Participants | Participants |
|
| Higher education | Education exceeds 12 years in total. | Count of Participants | Participants |
|
| Medications weekly | No. of different medications, weekly | Mean | Standard Deviation | medications |
|
| Practical assistance | Type of home care received | Count of Participants | Participants |
|
| Nursing | Type of home care received | Count of Participants | Participants |
|
| Safety alarm service | Type of home care received | Count of Participants | Participants |
|
| Walking aid | If a walking aid is used | Count of Participants | Participants |
|
| Falls | No. of falls in the last 12 months | Mean | Standard Deviation | falls |
|
| Falls injuries | Minor injuries from falls in the last 12 months | One missing value | Count of Participants | Participants |
|
| Mini-Mental Statement Examination | The Mini Mental Statement Examination (MMSE) is a measurement of global cognitive function. The highest score is 30, the lowest score is 0. A score below 23 indicates cognitive impairment which is an exclusion criteria in this study. | Mean | Standard Deviation | scores on a scale |
|
| Falls Efficacy Scale - International | 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). | Mean | Standard Deviation | scores on a scale |
|
| Instrumental Activities of Daily Living > 6 | No. of participants with a score higher than 6 on the Instrumental Activities of Daily Living (IADL) scale, Lawton and Brody. It 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). | Count of Participants | Participants |
|
| Sit-to-stand test | No. of raises from a chair in 30 seconds. From the sitting position, the subject stands completely up, then sits completely back down, repeated for 30 seconds. | Mean | Standard Deviation | raises |
|
| 4-meter walk test | One missing value | Mean | Standard Deviation | m/s |
|
| Berg Balance Scale | The Berg Balance Scale is a 14-item scale, which is applied to assess static and dynamic balance in older adults. The summary score ranges from 0 (low, wheelchair bound) to 56 (high, independent) | Mean | Standard Deviation | scores on a scale |
|
| Mini Nutritional Assessment | Risk of or being malnourished in the Mini Nutritional Assessment (MNA). The summary score of MNA ranges from 0 to 14, where a score below 12 indicates a risk of malnutrition or being malnourished. | Count of Participants | Participants |
|
| SF-36 Physical Component Summary | Physical Component Summary in the Short Form 36 Health Survey (SF-36). 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. | Mean | Standard Deviation | scores on a scale |
|
| SF-36 Mental Component Summary | Mental Component Summary in the Short Form 36 Health Survey (SF-36). 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. | Mean | Standard Deviation | scores on a scale |
|
| EQ-5D | Health-related quality of life measured by the EuroQOL EQ-5D instrument. 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. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Control | Activities as usual. |
|
|
| Secondary | EQ-5D | 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. | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | scores on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Berg Balance Scale | 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) | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | scores on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Sit-to-stand Test | 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. | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | raises | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 4-meter Walk Test | 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 | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | m/s | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Falls Efficacy Scale - International | 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. | Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors. | Posted | Mean | Standard Error | scores on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Instrumental Activities of Daily Living | 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). | Complete, non-missing observations for both groups at baseline. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up, with 1 missing observation on IADL. In the control group, 64 participants completed the 3-months follow-up. | Posted | Count of Participants | Participants | Baseline, 3-months, 6-months |
|
|
|
| Secondary | Walking Habits | Questions regarding walking habits in the last 7 days. Summarized in total minutes walking. | At baseline, one observation was missing in the intervention group. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up. In the control group, 64 participants completed the 3-months follow-up. | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Mini Nutritional Assessment | The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses "Normal nutritional status", "Risk of malnutrition" and being "Malnourished". | Complete, non-missing observations for both groups at baseline. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up. In the control group, 64 participants completed the 3-months follow-up, but 3 observations are missing. | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Exercise According to the Protocol. Adherence | 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. | All subjects in the intervention group with nonmissing observations at 3-months follow-up | Posted | Count of Participants | Participants | Baseline and 3 months |
|
|
|
| Secondary | No. of Participants Exercising Post-intervention | Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up. | All subjects with nonmissing observations at 6-months follow-up | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
|
| Secondary | No. of Falls | 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. | All subjects with nonmissing observations at 6-months follow-up | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
|
| 3 |
| 77 |
| 0 |
| 77 |
| 3 |
| 77 |
| EG001 | Control | Activities as usual. | 3 | 78 | 0 | 78 | 0 | 78 |
|
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| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| Serious injuries, hospitalization |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8, high function |
|
| 3-months follow-up |
|
|
| 6-months follow-up |
|
|
| 0-30 min |
|
| 30-90 min |
|
| 90-180 min |
|
| > 180 min |
|
| 3-months follow-up |
|
|
| 6-months follow-up |
|
|
| At risk of malnutrition |
|
| Malnourished |
|
| 3-months follow-up |
|
|
| 6-months follow-up |
|
|
| Group exercise |
|
| Both |
|