Accidental Falls
Conditions
Keywords
Falls, Home care, Older people, Falls prevention, Quality of life, Exercise, Balance, Preventative care, Community health services, Home-help services
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.
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.
Interventions
Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
Sponsors
Oslo Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
67 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 Health Survey Summary Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 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 | 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 | 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 | 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 | 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). |
| EQ-5D | 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. |
| Mini Nutritional Assessment | 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 | 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 | 3 months and 6 months | Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up. |
| No. of Falls | 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. |
| Walking Habits | Baseline, 3 months, 6 months | Questions regarding walking habits in the last 7 days. Summarized in total minutes walking. |
Countries
Norway
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence. | 77 |
| Control Activities as usual. | 78 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-months Follow-up | Death | 1 | 2 |
| 3-months Follow-up | Lost to Follow-up | 1 | 2 |
| 3-months Follow-up | Missed first follow-up | 5 | 1 |
| 3-months Follow-up | Withdrawal by Subject | 1 | 4 |
| 6-months Follow-up | Death | 2 | 1 |
| 6-months Follow-up | Lost to Follow-up | 1 | 2 |
| 6-months Follow-up | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| 4-meter walk test | 0.61 m/s STANDARD_DEVIATION 0.18 | 0.63 m/s STANDARD_DEVIATION 0.24 | 0.62 m/s STANDARD_DEVIATION 0.21 |
| Age, Continuous | 83.1 years STANDARD_DEVIATION 6.7 | 82.2 years STANDARD_DEVIATION 6.7 | 82.7 years STANDARD_DEVIATION 6.7 |
| Berg Balance Scale | 39.1 scores on a scale STANDARD_DEVIATION 11.1 | 39.1 scores on a scale STANDARD_DEVIATION 11.6 | 39.1 scores on a scale STANDARD_DEVIATION 11.3 |
| EQ-5D | 0.64 scores on a scale STANDARD_DEVIATION 0.21 | 0.60 scores on a scale STANDARD_DEVIATION 0.24 | 0.62 scores on a scale STANDARD_DEVIATION 0.23 |
| Falls | 2.5 falls STANDARD_DEVIATION 3.3 | 2.9 falls STANDARD_DEVIATION 4 | 2.7 falls STANDARD_DEVIATION 3.7 |
| Falls Efficacy Scale - International | 30.2 scores on a scale STANDARD_DEVIATION 10.1 | 31.1 scores on a scale STANDARD_DEVIATION 9.6 | 30.7 scores on a scale STANDARD_DEVIATION 9.8 |
| Falls injuries Minor injuries | 35 Participants | 35 Participants | 70 Participants |
| Falls injuries No injuries | 17 Participants | 13 Participants | 30 Participants |
| Falls injuries Serious injuries, hospitalization | 25 Participants | 29 Participants | 54 Participants |
| Higher education | 25 Participants | 31 Participants | 56 Participants |
| Instrumental Activities of Daily Living > 6 | 42 Participants | 45 Participants | 87 Participants |
| Living alone | 64 Participants | 67 Participants | 131 Participants |
| Medications weekly | 5.1 medications STANDARD_DEVIATION 3.7 | 5.4 medications STANDARD_DEVIATION 3.2 | 5.3 medications STANDARD_DEVIATION 3.4 |
| Mini-Mental Statement Examination | 27.4 scores on a scale STANDARD_DEVIATION 2.2 | 27.4 scores on a scale STANDARD_DEVIATION 2.2 | 27.4 scores on a scale STANDARD_DEVIATION 2.2 |
| Mini Nutritional Assessment No risk | 57 Participants | 60 Participants | 117 Participants |
| Mini Nutritional Assessment Risk of or malnourished | 20 Participants | 18 Participants | 38 Participants |
| Nursing | 20 Participants | 27 Participants | 47 Participants |
| Practical assistance | 50 Participants | 58 Participants | 108 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Safety alarm service | 61 Participants | 56 Participants | 117 Participants |
| Sex: Female, Male Female | 61 Participants | 62 Participants | 123 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
| SF-36 Mental Component Summary | 50.4 scores on a scale STANDARD_DEVIATION 9.9 | 48.4 scores on a scale STANDARD_DEVIATION 10.6 | 49.4 scores on a scale STANDARD_DEVIATION 10.3 |
| SF-36 Physical Component Summary | 38.2 scores on a scale STANDARD_DEVIATION 9 | 38.4 scores on a scale STANDARD_DEVIATION 9.1 | 38.3 scores on a scale STANDARD_DEVIATION 9 |
| Sit-to-stand test | 5.5 raises STANDARD_DEVIATION 3.8 | 4.7 raises STANDARD_DEVIATION 4.4 | 5.1 raises STANDARD_DEVIATION 4.1 |
| Walking aid | 60 Participants | 54 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 77 | 3 / 78 |
| other Total, other adverse events | 3 / 77 | 0 / 78 |
| serious Total, serious adverse events | 0 / 77 | 0 / 78 |
Outcome results
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Short Form 36 Health Survey Summary Scores | Change in PCS Baseline - 3-months follow-up | 3.7 scores on a scale | Standard Error 1 |
| Intervention | Short Form 36 Health Survey Summary Scores | Change in PCS Baseline - 6-months follow-up | 3.0 scores on a scale | Standard Error 0.9 |
| Intervention | Short Form 36 Health Survey Summary Scores | Change in MCS Baseline - 3-months follow-up | 0.7 scores on a scale | Standard Error 1.1 |
| Intervention | Short Form 36 Health Survey Summary Scores | Change in MCS Baseline - 6-months follow-up | 1.7 scores on a scale | Standard Error 1.1 |
| Control | Short Form 36 Health Survey Summary Scores | Change in MCS Baseline - 6-months follow-up | 4.7 scores on a scale | Standard Error 1.3 |
| Control | Short Form 36 Health Survey Summary Scores | Change in PCS Baseline - 3-months follow-up | -0.3 scores on a scale | Standard Error 0.9 |
| Control | Short Form 36 Health Survey Summary Scores | Change in MCS Baseline - 3-months follow-up | 3.8 scores on a scale | Standard Error 1.2 |
| Control | Short Form 36 Health Survey Summary Scores | Change in PCS Baseline - 6-months follow-up | 0.1 scores on a scale | Standard Error 0.9 |
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
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | 4-meter Walk Test | Change Baseline - 3-months follow-up | 0.06 m/s | Standard Error 0.02 |
| Intervention | 4-meter Walk Test | Change Baseline - 6-months follow-up | 0.05 m/s | Standard Error 0.02 |
| Control | 4-meter Walk Test | Change Baseline - 3-months follow-up | 0.06 m/s | Standard Error 0.02 |
| Control | 4-meter Walk Test | Change Baseline - 6-months follow-up | 0.05 m/s | Standard Error 0.02 |
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)
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Berg Balance Scale | Change Baseline - 3-months follow-up | 5.4 scores on a scale | Standard Error 0.8 |
| Intervention | Berg Balance Scale | Change Baseline - 6-months follow-up | 4.9 scores on a scale | Standard Error 0.9 |
| Control | Berg Balance Scale | Change Baseline - 3-months follow-up | 3.1 scores on a scale | Standard Error 0.9 |
| Control | Berg Balance Scale | Change Baseline - 6-months follow-up | 3.5 scores on a scale | Standard Error 0.9 |
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | EQ-5D | 3-months follow-up | 0.06 scores on a scale | Standard Error 0.02 |
| Intervention | EQ-5D | 6-months follow-up | 0.11 scores on a scale | Standard Error 0.02 |
| Control | EQ-5D | 3-months follow-up | 0.005 scores on a scale | Standard Error 0.03 |
| Control | EQ-5D | 6-months follow-up | -0.02 scores on a scale | Standard Error 0.03 |
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.
Time frame: Baseline and 3 months
Population: All subjects in the intervention group with nonmissing observations at 3-months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Exercise According to the Protocol. Adherence | 50 Participants |
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Falls Efficacy Scale - International | Change Baseline - 3-months follow-up | -1.7 scores on a scale | Standard Error 1.2 |
| Intervention | Falls Efficacy Scale - International | Change Baseline - 6-months follow-up | -1.7 scores on a scale | Standard Error 1.2 |
| Control | Falls Efficacy Scale - International | Change Baseline - 3-months follow-up | -2.3 scores on a scale | Standard Error 1.1 |
| Control | Falls Efficacy Scale - International | Change Baseline - 6-months follow-up | -1.3 scores on a scale | Standard Error 1.2 |
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).
Time frame: Baseline, 3-months, 6-months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Instrumental Activities of Daily Living | Baseline | 7 | 21 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 5 | 9 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 4 | 7 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 6 | 15 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 8, high function | 21 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 7 | 17 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 1 | 0 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 8, high function | 21 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 0, low function | 0 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 0, low function | 0 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 5 | 8 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 1 | 2 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 1 | 1 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 2 | 1 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 3 | 1 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 3 | 3 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 2 | 2 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 4 | 2 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 6 | 19 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 5 | 9 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 3 | 0 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 6 | 9 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 2 | 0 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 7 | 20 Participants |
| Intervention | Instrumental Activities of Daily Living | 3-months follow-up | 4 | 4 Participants |
| Intervention | Instrumental Activities of Daily Living | 6-months follow-up | 8, high function | 24 Participants |
| Intervention | Instrumental Activities of Daily Living | Baseline | 0, low function | 0 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 8, high function | 25 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 0, low function | 0 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 1 | 0 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 2 | 1 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 3 | 2 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 4 | 7 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 5 | 7 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 6 | 16 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 7 | 14 Participants |
| Control | Instrumental Activities of Daily Living | Baseline | 8, high function | 31 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 0, low function | 0 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 1 | 1 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 2 | 2 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 3 | 4 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 4 | 2 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 5 | 7 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 6 | 10 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 7 | 18 Participants |
| Control | Instrumental Activities of Daily Living | 3-months follow-up | 8, high function | 25 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 0, low function | 1 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 1 | 1 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 2 | 4 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 3 | 3 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 4 | 6 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 5 | 7 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 6 | 9 Participants |
| Control | Instrumental Activities of Daily Living | 6-months follow-up | 7 | 8 Participants |
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Mini Nutritional Assessment | Baseline | Normal nutritional status | 57 Participants |
| Intervention | Mini Nutritional Assessment | 3-months follow-up | Malnourished | 0 Participants |
| Intervention | Mini Nutritional Assessment | Baseline | Malnourished | 3 Participants |
| Intervention | Mini Nutritional Assessment | 6-months follow-up | Normal nutritional status | 55 Participants |
| Intervention | Mini Nutritional Assessment | 3-months follow-up | Normal nutritional status | 48 Participants |
| Intervention | Mini Nutritional Assessment | 6-months follow-up | At risk of malnutrition | 14 Participants |
| Intervention | Mini Nutritional Assessment | Baseline | At risk of malnutrition | 17 Participants |
| Intervention | Mini Nutritional Assessment | 6-months follow-up | Malnourished | 2 Participants |
| Intervention | Mini Nutritional Assessment | 3-months follow-up | At risk of malnutrition | 21 Participants |
| Control | Mini Nutritional Assessment | 6-months follow-up | Malnourished | 3 Participants |
| Control | Mini Nutritional Assessment | Baseline | Normal nutritional status | 60 Participants |
| Control | Mini Nutritional Assessment | Baseline | At risk of malnutrition | 18 Participants |
| Control | Mini Nutritional Assessment | 3-months follow-up | Normal nutritional status | 44 Participants |
| Control | Mini Nutritional Assessment | 3-months follow-up | At risk of malnutrition | 21 Participants |
| Control | Mini Nutritional Assessment | 3-months follow-up | Malnourished | 4 Participants |
| Control | Mini Nutritional Assessment | 6-months follow-up | Normal nutritional status | 35 Participants |
| Control | Mini Nutritional Assessment | 6-months follow-up | At risk of malnutrition | 23 Participants |
| Control | Mini Nutritional Assessment | Baseline | Malnourished | 0 Participants |
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.
Time frame: 3 months and 6 months
Population: All subjects with nonmissing observations at 6-months follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | No. of Falls | No falls | 57 Participants |
| Intervention | No. of Falls | One or more falls | 14 Participants |
| Control | No. of Falls | No falls | 41 Participants |
| Control | No. of Falls | One or more falls | 23 Participants |
Secondary
No. of Participants Exercising Post-intervention
Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.
Time frame: 3 months and 6 months
Population: All subjects with nonmissing observations at 6-months follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | No. of Participants Exercising Post-intervention | None | 14 Participants |
| Intervention | No. of Participants Exercising Post-intervention | Individual exercise | 46 Participants |
| Intervention | No. of Participants Exercising Post-intervention | Group exercise | 3 Participants |
| Intervention | No. of Participants Exercising Post-intervention | Both | 8 Participants |
| Control | No. of Participants Exercising Post-intervention | Both | 4 Participants |
| Control | No. of Participants Exercising Post-intervention | None | 23 Participants |
| Control | No. of Participants Exercising Post-intervention | Group exercise | 11 Participants |
| Control | No. of Participants Exercising Post-intervention | Individual exercise | 25 Participants |
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.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Sit-to-stand Test | Change Baseline - 3-months follow-up | 1.2 raises | Standard Error 0.4 |
| Intervention | Sit-to-stand Test | Change Baseline - 6-months follow-up | 1.2 raises | Standard Error 0.4 |
| Control | Sit-to-stand Test | Change Baseline - 3-months follow-up | 0.8 raises | Standard Error 0.4 |
| Control | Sit-to-stand Test | Change Baseline - 6-months follow-up | 1.1 raises | Standard Error 0.4 |
Secondary
Walking Habits
Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.
Time frame: Baseline, 3 months, 6 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention | Walking Habits | Baseline | > 180 min | 14 Participants |
| Intervention | Walking Habits | 3-months follow-up | 90-180 min | 13 Participants |
| Intervention | Walking Habits | Baseline | 0-30 min | 21 Participants |
| Intervention | Walking Habits | 3-months follow-up | > 180 min | 20 Participants |
| Intervention | Walking Habits | 3-months follow-up | 0 min | 9 Participants |
| Intervention | Walking Habits | 6-months follow-up | 0 min | 10 Participants |
| Intervention | Walking Habits | Baseline | 90-180 min | 15 Participants |
| Intervention | Walking Habits | 6-months follow-up | 0-30 min | 15 Participants |
| Intervention | Walking Habits | 3-months follow-up | 0-30 min | 11 Participants |
| Intervention | Walking Habits | 6-months follow-up | 30-90 min | 17 Participants |
| Intervention | Walking Habits | Baseline | 30-90 min | 20 Participants |
| Intervention | Walking Habits | 6-months follow-up | 90-180 min | 13 Participants |
| Intervention | Walking Habits | 3-months follow-up | 30-90 min | 16 Participants |
| Intervention | Walking Habits | 6-months follow-up | > 180 min | 16 Participants |
| Intervention | Walking Habits | Baseline | 0 min | 6 Participants |
| Control | Walking Habits | 6-months follow-up | > 180 min | 11 Participants |
| Control | Walking Habits | Baseline | 0 min | 6 Participants |
| Control | Walking Habits | Baseline | 0-30 min | 16 Participants |
| Control | Walking Habits | Baseline | 30-90 min | 27 Participants |
| Control | Walking Habits | Baseline | 90-180 min | 18 Participants |
| Control | Walking Habits | Baseline | > 180 min | 11 Participants |
| Control | Walking Habits | 3-months follow-up | 0 min | 17 Participants |
| Control | Walking Habits | 3-months follow-up | 0-30 min | 16 Participants |
| Control | Walking Habits | 3-months follow-up | 30-90 min | 16 Participants |
| Control | Walking Habits | 3-months follow-up | 90-180 min | 7 Participants |
| Control | Walking Habits | 3-months follow-up | > 180 min | 13 Participants |
| Control | Walking Habits | 6-months follow-up | 0 min | 16 Participants |
| Control | Walking Habits | 6-months follow-up | 0-30 min | 13 Participants |
| Control | Walking Habits | 6-months follow-up | 30-90 min | 16 Participants |
| Control | Walking Habits | 6-months follow-up | 90-180 min | 8 Participants |