Accidental Falls
Conditions
Keywords
exergaming, Senior Fitness Test
Brief summary
This study evaluates the use of Playware technology for balance training. Falling among elder is a costly problem. Research shows that training can help prevent falls. Pilot studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly increase their physical abilities. The interventions group will train using interactive modular tiles. The tiles include preprogrammed games that create playful training for the participants. The control group will receive usual care, which here refers to normal day activities. The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time.
Detailed description
This study will investigate the use of one form of exergames called IMT how this compared to usual care of elderly people 70+. The trial will consist of two groups, one for training with the IMT and usual care that will receive the care provided to non-patients elderly, which at this moment is no additional treatment other than recommendations. The study will be single blinded, randomized controlled trial. It will be funded by the patient@home project and Entertainment robotics. Concealed allocation and intention-to-treat analysis will be used. Measurements will be taken at baseline and after intervention. Upon acceptance the protocol will be registered in clinicaltrials.gov. The trial's results will be reported using domains and categories described in the taxonomy developed by the Prevention of Falls Network Europe, to allow future synthesis of evidence, or study replication. The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training. The control group will not train.
Interventions
DEVICETraining on Interactive Modulare Tiles
Training with the Interactive Modulare Tiles
Sponsors
Technical University of Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Community-dwelling * 70+ years
Exclusion criteria
* A previous diagnosis of strong dementia or a cognitive decline that prevents the understanding of simple instructions or guidelines; * A previous stroke with a severe neurological impairment, such as loss of strength, and perceptual or language limitations; * A severe visual deficiency; * Inability to maintain a standing position, even with the use of a walking aid or other device; * Participating in rehabilitative training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Test Score of 6 Minute Walking Test at Week 14. | Baseline and at week 14 | Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14. |
| Change From Baseline in Test Score of 30-second Chair Stand at Week 14. | Baseline and at week 14 | Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14. |
| Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14. | Baseline and at week 14 | Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation for Training | At week 14. | Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT. |
| Change From Baseline in Test Score of Line Walk at Week 14. | Baseline and at week 14 | Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14. |
| Acceptability of IMT | At week 14. | Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT |
| Change From Baseline in Test Score of Static Balance at Week 14. | Baseline and at week 14 | Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14. |
| Adherence to Training, Composite Outcome Measure. | At week 14 | Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Training The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.
The intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).
Training on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles | 30 |
| Control No training. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 6 |
| Overall Study | Only partially tested | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Control | Training |
|---|---|---|---|
| 6 Minute Walking Test | 238.73 Meters STANDARD_DEVIATION 83.12 | 237.18 Meters STANDARD_DEVIATION 94.77 | 240.28 Meters STANDARD_DEVIATION 71.21 |
| Age, Continuous | 82.73 years STANDARD_DEVIATION 6.57 | 82.37 years STANDARD_DEVIATION 6.61 | 83.14 years STANDARD_DEVIATION 6.69 |
| BMI | 26.16 kg/m^2 STANDARD_DEVIATION 4.8 | 26.16 kg/m^2 STANDARD_DEVIATION 4.45 | 26.17 kg/m^2 STANDARD_DEVIATION 5.21 |
| Chair Stand | 9 Chair stands per 30 seconds STANDARD_DEVIATION 4.17 | 8.77 Chair stands per 30 seconds STANDARD_DEVIATION 3.91 | 9.23 Chair stands per 30 seconds STANDARD_DEVIATION 4.47 |
| Height | 1.63 cm | 1.65 cm | 1.62 cm |
| Line Walk | 2.93 Steps STANDARD_DEVIATION 3.56 | 3.50 Steps STANDARD_DEVIATION 2.49 | 2.37 Steps STANDARD_DEVIATION 4.36 |
| Sex: Female, Male Female | 53 Participants | 25 Participants | 28 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 2 Participants |
| Timed Up and Go | 12.80 Seconds STANDARD_DEVIATION 7.96 | 13.35 Seconds STANDARD_DEVIATION 10.1 | 12.24 Seconds STANDARD_DEVIATION 5.13 |
| Weight | 69.73 kg STANDARD_DEVIATION 13.25 | 71.13 kg STANDARD_DEVIATION 13.34 | 68.33 kg STANDARD_DEVIATION 13.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change From Baseline in Test Score of 30-second Chair Stand at Week 14.
Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.
Time frame: Baseline and at week 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training | Change From Baseline in Test Score of 30-second Chair Stand at Week 14. | 2.05 Full chair stands per 30 seconds |
| Control | Change From Baseline in Test Score of 30-second Chair Stand at Week 14. | 0.455 Full chair stands per 30 seconds |
Primary
Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.
Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.
Time frame: Baseline and at week 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training | Change From Baseline in Test Score of 6 Minute Walking Test at Week 14. | 1.07 m |
| Control | Change From Baseline in Test Score of 6 Minute Walking Test at Week 14. | 0.568 m |
Primary
Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.
Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.
Time frame: Baseline and at week 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training | Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14. | -1.38 seconds |
| Control | Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14. | -0.0473 seconds |
Secondary
Acceptability of IMT
Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT
Time frame: At week 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training | Acceptability of IMT | 90 percentage of happy to train on IMT |
Secondary
Adherence to Training, Composite Outcome Measure.
Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.
Time frame: At week 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training | Adherence to Training, Composite Outcome Measure. | 90.6 percentage of sessions |
Secondary
Change From Baseline in Test Score of Line Walk at Week 14.
Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.
Time frame: Baseline and at week 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training | Change From Baseline in Test Score of Line Walk at Week 14. | 2.23 Steps |
| Control | Change From Baseline in Test Score of Line Walk at Week 14. | 1.09 Steps |
Secondary
Change From Baseline in Test Score of Static Balance at Week 14.
Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.
Time frame: Baseline and at week 14
Population: Data were not collected.
Secondary
Motivation for Training
Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.
Time frame: At week 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training | Motivation for Training | 85 percentage of wanting to continue |