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

NCT ID: NCT01704976

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Poor Performance Status; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1

Group Type: EXPERIMENTAL

SR-WBV

Intervention Type: DEVICE

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

Sham group

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1

Group Type: SHAM_COMPARATOR

SR-WBV

Intervention Type: DEVICE

Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.

Interventions

SR-WBV

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

Intervention Type: DEVICE

SR-WBV

Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.

Intervention Type: DEVICE

Other Intervention Names

SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland); Intervention-Group; SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bern University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Slavko Rogan

PTMsc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rogan Slavko, MSc

Role: STUDY_CHAIR

Bern University of Applied Science, Department WGS

Radlinger Lorenz, PhD

Role: STUDY_DIRECTOR

Bern University of Applied Science, Department WGS

Baur Heiner, PhD

Role: PRINCIPAL_INVESTIGATOR

Bern University of Applied Sciences

Jessica Kessler, MSc

Role: STUDY_CHAIR

BUAS

Locations

Slavko Rogan

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 25042993 (View on PubMed)

Other Identifiers

MSc-study (Biel)

Identifier Type: -

Identifier Source: org_study_id