NCT01704976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
23 days until next milestone

Results Posted

Study results publicly available

December 24, 2014

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

October 7, 2012

Results QC Date

July 12, 2014

Last Update Submit

January 28, 2019

Conditions

Poor Performance StatusMuscle Weakness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor

    after 4 weeks

  • Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension

    after 4 weeks

  • Isometric Rate of Force Development (IRFD) Right Knee-extensor

    after 4 weeks

  • Isometric Rate of Force Development (IRFD) Left Knee-extensor

    after 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: SR-WBV

Sham group

SHAM COMPARATOR

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

Device: SR-WBV

Interventions

SR-WBVDEVICE

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

Also known as: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland), Intervention-Group
Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slavko Rogan

Bern, 3008, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25042993DERIVED

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Results Point of Contact

Title
Slavko Rogan (Study Chair)
Organization
BUAS
slavko.rogan@bfh.ch
+41 31 848 35 56

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PTMsc

Study Record Dates

First Submitted

October 7, 2012

First Posted

October 12, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

February 12, 2019

Results First Posted

December 24, 2014

Record last verified: 2019-01

Locations

CH(1)