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This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.
This study is based on the guideline of falls management exercise programs (FaME; from Skelton and Dinan).
The goals:
Skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth, improvement of bone density and multi-sensory exercises.
First, a pilot study was conducted with untrained elderly ("Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Clinical Trial Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control Clinical Trial Registry:NCT01543243).
It was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. But for frail elderly the chosen form of recruitment and the measurement methods are not sufficient.
For this study, measurement parameters for functional performance and strength will be used.
Goals of the study in the skilling up phase:
The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1 |
|
| Sham group | Sham Comparator | T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR-WBV | Device | Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Functional Performance | Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living. The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is "Poor performance"; SPPB 7-9 is "Intermediate performance; SPPB 10-12 is "High Performance". | after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor | It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. | after 4 weeks |
| Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogan Slavko, MSc | Bern University of Applied Science, Department WGS | Study Chair |
| Radlinger Lorenz, PhD | Bern University of Applied Science, Department WGS | Study Director |
| Baur Heiner, PhD | Bern University of Applied Sciences | Principal Investigator |
| Jessica Kessler, MSc | BUAS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slavko Rogan | Bern | 3008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25042993 | Derived | Kessler J, Radlinger L, Baur H, Rogan S. Effect of stochastic resonance whole body vibration on functional performance in the frail elderly: A pilot study. Arch Gerontol Geriatr. 2014 Sep-Oct;59(2):305-11. doi: 10.1016/j.archger.2014.06.005. Epub 2014 Jul 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | T0 - intervention 4 weeks - T1 Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4. |
| FG001 | Sham | T0- Intervention 4 weeks- T1 Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | T0 - intervention 4 weeks - T1 Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4. |
| BG001 | Sham |
| 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 | Physical Functional Performance | Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living. The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is "Poor performance"; SPPB 7-9 is "Intermediate performance; SPPB 10-12 is "High Performance". | Posted | Median | Inter-Quartile Range | units on a scale | after 4 weeks |
|
zero period
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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 | T0 - intervention 4 weeks - T1 Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Slavko Rogan (Study Chair) | BUAS | +41 31 848 35 56 | slavko.rogan@bfh.ch |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| SR-WBV | Device | Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1. |
|
|
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
| after 4 weeks |
| Isometric Rate of Force Development (IRFD) Right Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | after 4 weeks |
| Isometric Rate of Force Development (IRFD) Left Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | after 4 weeks |
T0- Intervention 4 weeks- T1
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Total sum score of the Short Physical Performance Battery Test | "Short physical performance battery (SPBB): The SPBB examines three areas of lower extremity function:
| Median | Inter-Quartile Range | sum of points |
|
| Sham |
T0- Intervention 4 weeks- T1 Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1. |
|
|
|
| Secondary | Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor | It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. | Posted | Median | Inter-Quartile Range | Newton | after 4 weeks |
|
|
|
|
| Secondary | Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension | It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. | Posted | Median | Inter-Quartile Range | Newton | after 4 weeks |
|
|
|
|
| Secondary | Isometric Rate of Force Development (IRFD) Right Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | Posted | Median | Inter-Quartile Range | Newton/seconds | after 4 weeks |
|
|
|
|
| Secondary | Isometric Rate of Force Development (IRFD) Left Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | Posted | Median | Inter-Quartile Range | Newton/seconds | after 4 weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Sham | T0- Intervention 4 weeks- T1 Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1. | 0 | 11 | 0 | 11 |
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |