SR-WBV Training for Frail Elderly in the Skilling up Stage

Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01704976

Enrollment

Registered

2012-10-12

Start date

2012-09-30

Completion date

2014-12-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Performance Status, Muscle Weakness

Brief summary

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.

Detailed description

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: 1. Feasibility 2. Study the effect on physical functional performance 3. Study the effects on muscle strength. The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.

Interventions

DEVICESR-WBV

Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* RAI (Resident Assessment Instrument) \>0 * live in canton Bern * in terms of training load be resistant.

Exclusion criteria

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute -- surgical scars * seniors with prosthesis. * alcoholic * acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb * acute inflammation or infection tumors * fresh surgical wounds * severe migraine * epilepsy * acute severe pain

Design outcomes

Primary

Measure	Time frame	Description
Physical Functional Performance	after 4 weeks	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.

Secondary

Measure	Time frame	Description
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor	after 4 weeks	It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension	after 4 weeks	It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Isometric Rate of Force Development (IRFD) Right Knee-extensor	after 4 weeks	It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Isometric Rate of Force Development (IRFD) Left Knee-extensor	after 4 weeks	It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
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.	13
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.	11
Total	24

Baseline characteristics

Characteristic	Intervention	Sham	Total
Age, Continuous Age	90.7 years STANDARD_DEVIATION 7.5	83.8 years STANDARD_DEVIATION 9.3	87.3 years STANDARD_DEVIATION 9.3
Sex: Female, Male Female	7 Participants	7 Participants	14 Participants
Sex: Female, Male Male	6 Participants	4 Participants	10 Participants
Total sum score of the Short Physical Performance Battery Test	3 sum of points	4 sum of points	3 sum of points

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 13	0 / 11
serious Total, serious adverse events	0 / 13	0 / 11

Outcome results

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.

Time frame: after 4 weeks

Arm	Measure	Group	Value (MEDIAN)
Intervention	Physical Functional Performance	Pre-intervention	3 units on a scale
Intervention	Physical Functional Performance	Post-intervention	6 units on a scale
Sham	Physical Functional Performance	Pre-intervention	4 units on a scale
Sham	Physical Functional Performance	Post-intervention	4 units on a scale