Trial Outcomes & Findings for Falls Prevention in Older Home Care Recipients (NCT NCT02374307)
NCT ID: NCT02374307
Last Updated: 2019-11-14
Results Overview
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.
COMPLETED
NA
155 participants
Baseline, 3 months, 6 months
2019-11-14
Participant Flow
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.
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.
Participant milestones
| Measure |
Intervention
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
Activities as usual.
|
|---|---|---|
|
3-months Follow-up
STARTED
|
77
|
78
|
|
3-months Follow-up
COMPLETED
|
69
|
69
|
|
3-months Follow-up
NOT COMPLETED
|
8
|
9
|
|
6-months Follow-up
STARTED
|
74
|
70
|
|
6-months Follow-up
COMPLETED
|
71
|
64
|
|
6-months Follow-up
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Intervention
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
Activities as usual.
|
|---|---|---|
|
3-months Follow-up
Lost to Follow-up
|
1
|
2
|
|
3-months Follow-up
Withdrawal by Subject
|
1
|
4
|
|
3-months Follow-up
Death
|
1
|
2
|
|
3-months Follow-up
Missed first follow-up
|
5
|
1
|
|
6-months Follow-up
Lost to Follow-up
|
1
|
2
|
|
6-months Follow-up
Death
|
2
|
1
|
|
6-months Follow-up
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.1 years
STANDARD_DEVIATION 6.7 • n=77 Participants
|
82.2 years
STANDARD_DEVIATION 6.7 • n=78 Participants
|
82.7 years
STANDARD_DEVIATION 6.7 • n=155 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=77 Participants
|
62 Participants
n=78 Participants
|
123 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=77 Participants
|
16 Participants
n=78 Participants
|
32 Participants
n=155 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Living alone
|
64 Participants
n=77 Participants
|
67 Participants
n=78 Participants
|
131 Participants
n=155 Participants
|
|
Higher education
|
25 Participants
n=77 Participants
|
31 Participants
n=78 Participants
|
56 Participants
n=155 Participants
|
|
Medications weekly
|
5.1 medications
STANDARD_DEVIATION 3.7 • n=77 Participants
|
5.4 medications
STANDARD_DEVIATION 3.2 • n=78 Participants
|
5.3 medications
STANDARD_DEVIATION 3.4 • n=155 Participants
|
|
Practical assistance
|
50 Participants
n=77 Participants
|
58 Participants
n=78 Participants
|
108 Participants
n=155 Participants
|
|
Nursing
|
20 Participants
n=77 Participants
|
27 Participants
n=78 Participants
|
47 Participants
n=155 Participants
|
|
Safety alarm service
|
61 Participants
n=77 Participants
|
56 Participants
n=78 Participants
|
117 Participants
n=155 Participants
|
|
Walking aid
|
60 Participants
n=77 Participants
|
54 Participants
n=78 Participants
|
114 Participants
n=155 Participants
|
|
Falls
|
2.5 falls
STANDARD_DEVIATION 3.3 • n=77 Participants
|
2.9 falls
STANDARD_DEVIATION 4.0 • n=78 Participants
|
2.7 falls
STANDARD_DEVIATION 3.7 • n=155 Participants
|
|
Falls injuries
No injuries
|
17 Participants
n=77 Participants • One missing value
|
13 Participants
n=77 Participants • One missing value
|
30 Participants
n=154 Participants • One missing value
|
|
Falls injuries
Minor injuries
|
35 Participants
n=77 Participants • One missing value
|
35 Participants
n=77 Participants • One missing value
|
70 Participants
n=154 Participants • One missing value
|
|
Falls injuries
Serious injuries, hospitalization
|
25 Participants
n=77 Participants • One missing value
|
29 Participants
n=77 Participants • One missing value
|
54 Participants
n=154 Participants • One missing value
|
|
Mini-Mental Statement Examination
|
27.4 scores on a scale
STANDARD_DEVIATION 2.2 • n=77 Participants
|
27.4 scores on a scale
STANDARD_DEVIATION 2.2 • n=78 Participants
|
27.4 scores on a scale
STANDARD_DEVIATION 2.2 • n=155 Participants
|
|
Falls Efficacy Scale - International
|
30.2 scores on a scale
STANDARD_DEVIATION 10.1 • n=77 Participants
|
31.1 scores on a scale
STANDARD_DEVIATION 9.6 • n=78 Participants
|
30.7 scores on a scale
STANDARD_DEVIATION 9.8 • n=155 Participants
|
|
Instrumental Activities of Daily Living > 6
|
42 Participants
n=77 Participants
|
45 Participants
n=78 Participants
|
87 Participants
n=155 Participants
|
|
Sit-to-stand test
|
5.5 raises
STANDARD_DEVIATION 3.8 • n=77 Participants
|
4.7 raises
STANDARD_DEVIATION 4.4 • n=78 Participants
|
5.1 raises
STANDARD_DEVIATION 4.1 • n=155 Participants
|
|
4-meter walk test
|
0.61 m/s
STANDARD_DEVIATION 0.18 • n=76 Participants • One missing value
|
0.63 m/s
STANDARD_DEVIATION 0.24 • n=78 Participants • One missing value
|
0.62 m/s
STANDARD_DEVIATION 0.21 • n=154 Participants • One missing value
|
|
Berg Balance Scale
|
39.1 scores on a scale
STANDARD_DEVIATION 11.1 • n=77 Participants
|
39.1 scores on a scale
STANDARD_DEVIATION 11.6 • n=78 Participants
|
39.1 scores on a scale
STANDARD_DEVIATION 11.3 • n=155 Participants
|
|
Mini Nutritional Assessment
No risk
|
57 Participants
n=77 Participants
|
60 Participants
n=78 Participants
|
117 Participants
n=155 Participants
|
|
Mini Nutritional Assessment
Risk of or malnourished
|
20 Participants
n=77 Participants
|
18 Participants
n=78 Participants
|
38 Participants
n=155 Participants
|
|
SF-36 Physical Component Summary
|
38.2 scores on a scale
STANDARD_DEVIATION 9.0 • n=77 Participants
|
38.4 scores on a scale
STANDARD_DEVIATION 9.1 • n=78 Participants
|
38.3 scores on a scale
STANDARD_DEVIATION 9.0 • n=155 Participants
|
|
SF-36 Mental Component Summary
|
50.4 scores on a scale
STANDARD_DEVIATION 9.9 • n=77 Participants
|
48.4 scores on a scale
STANDARD_DEVIATION 10.6 • n=78 Participants
|
49.4 scores on a scale
STANDARD_DEVIATION 10.3 • n=155 Participants
|
|
EQ-5D
|
0.64 scores on a scale
STANDARD_DEVIATION 0.21 • n=77 Participants
|
0.60 scores on a scale
STANDARD_DEVIATION 0.24 • n=78 Participants
|
0.62 scores on a scale
STANDARD_DEVIATION 0.23 • n=155 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Short Form 36 Health Survey Summary Scores
Change in PCS Baseline - 3-months follow-up
|
3.7 scores on a scale
Standard Error 1.0
|
-0.3 scores on a scale
Standard Error 0.9
|
|
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
|
0.1 scores on a scale
Standard Error 0.9
|
|
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
|
3.8 scores on a scale
Standard Error 1.2
|
|
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
|
4.7 scores on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
EQ-5D
3-months follow-up
|
0.06 scores on a scale
Standard Error 0.02
|
0.005 scores on a scale
Standard Error 0.03
|
|
EQ-5D
6-months follow-up
|
0.11 scores on a scale
Standard Error 0.02
|
-0.02 scores on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Berg Balance Scale
Change Baseline - 3-months follow-up
|
5.4 scores on a scale
Standard Error 0.8
|
3.1 scores on a scale
Standard Error 0.9
|
|
Berg Balance Scale
Change Baseline - 6-months follow-up
|
4.9 scores on a scale
Standard Error 0.9
|
3.5 scores on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Sit-to-stand Test
Change Baseline - 3-months follow-up
|
1.2 raises
Standard Error 0.4
|
0.8 raises
Standard Error 0.4
|
|
Sit-to-stand Test
Change Baseline - 6-months follow-up
|
1.2 raises
Standard Error 0.4
|
1.1 raises
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
4-meter Walk Test
Change Baseline - 3-months follow-up
|
0.06 m/s
Standard Error 0.02
|
0.06 m/s
Standard Error 0.02
|
|
4-meter Walk Test
Change Baseline - 6-months follow-up
|
0.05 m/s
Standard Error 0.02
|
0.05 m/s
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Falls Efficacy Scale - International
Change Baseline - 3-months follow-up
|
-1.7 scores on a scale
Standard Error 1.2
|
-2.3 scores on a scale
Standard Error 1.1
|
|
Falls Efficacy Scale - International
Change Baseline - 6-months follow-up
|
-1.7 scores on a scale
Standard Error 1.2
|
-1.3 scores on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline, 3-months, 6-monthsPopulation: 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.
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).
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Instrumental Activities of Daily Living
3-months follow-up · 2
|
2 Participants
|
2 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 0, low function
|
0 Participants
|
0 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 1
|
0 Participants
|
0 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 2
|
0 Participants
|
1 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 3
|
1 Participants
|
2 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 4
|
7 Participants
|
7 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 5
|
8 Participants
|
7 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 6
|
19 Participants
|
16 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 7
|
21 Participants
|
14 Participants
|
|
Instrumental Activities of Daily Living
Baseline · 8, high function
|
21 Participants
|
31 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 0, low function
|
0 Participants
|
0 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 1
|
1 Participants
|
1 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 3
|
0 Participants
|
4 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 4
|
4 Participants
|
2 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 5
|
9 Participants
|
7 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 6
|
15 Participants
|
10 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 7
|
17 Participants
|
18 Participants
|
|
Instrumental Activities of Daily Living
3-months follow-up · 8, high function
|
21 Participants
|
25 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 0, low function
|
0 Participants
|
1 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 1
|
2 Participants
|
1 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 2
|
1 Participants
|
4 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 3
|
3 Participants
|
3 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 4
|
2 Participants
|
6 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 5
|
9 Participants
|
7 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 6
|
9 Participants
|
9 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 7
|
20 Participants
|
8 Participants
|
|
Instrumental Activities of Daily Living
6-months follow-up · 8, high function
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Walking Habits
Baseline · 0 min
|
6 Participants
|
6 Participants
|
|
Walking Habits
Baseline · 0-30 min
|
21 Participants
|
16 Participants
|
|
Walking Habits
Baseline · 30-90 min
|
20 Participants
|
27 Participants
|
|
Walking Habits
Baseline · 90-180 min
|
15 Participants
|
18 Participants
|
|
Walking Habits
Baseline · > 180 min
|
14 Participants
|
11 Participants
|
|
Walking Habits
3-months follow-up · 0 min
|
9 Participants
|
17 Participants
|
|
Walking Habits
3-months follow-up · 0-30 min
|
11 Participants
|
16 Participants
|
|
Walking Habits
3-months follow-up · 30-90 min
|
16 Participants
|
16 Participants
|
|
Walking Habits
3-months follow-up · 90-180 min
|
13 Participants
|
7 Participants
|
|
Walking Habits
3-months follow-up · > 180 min
|
20 Participants
|
13 Participants
|
|
Walking Habits
6-months follow-up · 0 min
|
10 Participants
|
16 Participants
|
|
Walking Habits
6-months follow-up · 0-30 min
|
15 Participants
|
13 Participants
|
|
Walking Habits
6-months follow-up · 30-90 min
|
17 Participants
|
16 Participants
|
|
Walking Habits
6-months follow-up · 90-180 min
|
13 Participants
|
8 Participants
|
|
Walking Habits
6-months follow-up · > 180 min
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 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.
The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses "Normal nutritional status", "Risk of malnutrition" and being "Malnourished".
Outcome measures
| Measure |
Intervention
n=77 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 Participants
Activities as usual.
|
|---|---|---|
|
Mini Nutritional Assessment
6-months follow-up · Normal nutritional status
|
55 Participants
|
35 Participants
|
|
Mini Nutritional Assessment
Baseline · Normal nutritional status
|
57 Participants
|
60 Participants
|
|
Mini Nutritional Assessment
Baseline · At risk of malnutrition
|
17 Participants
|
18 Participants
|
|
Mini Nutritional Assessment
Baseline · Malnourished
|
3 Participants
|
0 Participants
|
|
Mini Nutritional Assessment
3-months follow-up · Normal nutritional status
|
48 Participants
|
44 Participants
|
|
Mini Nutritional Assessment
3-months follow-up · At risk of malnutrition
|
21 Participants
|
21 Participants
|
|
Mini Nutritional Assessment
3-months follow-up · Malnourished
|
0 Participants
|
4 Participants
|
|
Mini Nutritional Assessment
6-months follow-up · At risk of malnutrition
|
14 Participants
|
23 Participants
|
|
Mini Nutritional Assessment
6-months follow-up · Malnourished
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: All subjects in the intervention group with nonmissing observations at 3-months follow-up
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.
Outcome measures
| Measure |
Intervention
n=68 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
Activities as usual.
|
|---|---|---|
|
Exercise According to the Protocol. Adherence
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: All subjects with nonmissing observations at 6-months follow-up
Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.
Outcome measures
| Measure |
Intervention
n=71 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=63 Participants
Activities as usual.
|
|---|---|---|
|
No. of Participants Exercising Post-intervention
None
|
14 Participants
|
23 Participants
|
|
No. of Participants Exercising Post-intervention
Individual exercise
|
46 Participants
|
25 Participants
|
|
No. of Participants Exercising Post-intervention
Group exercise
|
3 Participants
|
11 Participants
|
|
No. of Participants Exercising Post-intervention
Both
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: All subjects with nonmissing observations at 6-months follow-up
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.
Outcome measures
| Measure |
Intervention
n=71 Participants
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=64 Participants
Activities as usual.
|
|---|---|---|
|
No. of Falls
No falls
|
57 Participants
|
41 Participants
|
|
No. of Falls
One or more falls
|
14 Participants
|
23 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=77 participants at risk
Exercise and education: Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
|
Control
n=78 participants at risk
Activities as usual.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain/discomfort
|
3.9%
3/77 • Study period of 6 months
Adverse events definition also included falls, cardiovascular events or musculoskeletal injuries when performing exercises.
|
0.00%
0/78 • Study period of 6 months
Adverse events definition also included falls, cardiovascular events or musculoskeletal injuries when performing exercises.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place