Trial Outcomes & Findings for SR-WBV Training for Frail Elderly in the Skilling up Stage (NCT NCT01704976)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

after 4 weeks

Results posted on

2019-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	14	13
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.	Total n=24 Participants Total of all reporting groups
Age, Continuous Age	90.7 years STANDARD_DEVIATION 7.5 • n=5 Participants	83.8 years STANDARD_DEVIATION 9.3 • n=7 Participants	87.3 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Total sum score of the Short Physical Performance Battery Test	3 sum of points n=5 Participants	4 sum of points n=7 Participants	3 sum of points n=5 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.
Physical Functional Performance Pre-intervention	3 units on a scale Interval 2.0 to 4.5	4 units on a scale Interval 2.0 to 6.0
Physical Functional Performance Post-intervention	6 units on a scale Interval 3.5 to 7.5	4 units on a scale Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: after 4 weeks

It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor Pre-intervention	115.1 Newton Interval 79.0 to 183.0	141.4 Newton Interval 95.0 to 143.0
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor Post-intervention	127.1 Newton Interval 93.0 to 164.0	128.7 Newton Interval 69.0 to 172.0

SECONDARY outcome

Timeframe: after 4 weeks

It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension Pre-intervention	83.2 Newton Interval 68.0 to 195.0	115.8 Newton Interval 77.0 to 176.0
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension Post-intervention	154 Newton Interval 91.0 to 211.0	129 Newton Interval 48.0 to 166.0

SECONDARY outcome

Timeframe: after 4 weeks

It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.
Isometric Rate of Force Development (IRFD) Right Knee-extensor Pre-intervention	489.8 Newton/seconds Interval 223.0 to 1307.0	558.5 Newton/seconds Interval 412.0 to 1272.0
Isometric Rate of Force Development (IRFD) Right Knee-extensor Post-intervention	510 Newton/seconds Interval 295.0 to 1166.0	560 Newton/seconds Interval 256.0 to 906.0

SECONDARY outcome

Timeframe: after 4 weeks

It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.

Outcome measures

Outcome measures
Measure	Intervention n=13 Participants 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.	Sham n=11 Participants 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.
Isometric Rate of Force Development (IRFD) Left Knee-extensor Pre-intervention	284.7 Newton/seconds Interval 190.0 to 1100.0	546.2 Newton/seconds Interval 347.0 to 920.0
Isometric Rate of Force Development (IRFD) Left Knee-extensor Post-intervention	580.3 Newton/seconds Interval 247.0 to 1140.0	521 Newton/seconds Interval 154.0 to 793.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Slavko Rogan (Study Chair)

BUAS

Phone: +41 31 848 35 56

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place