NCT02102919

Brief Summary

The goal of this randomized controlled study was to examine the effects of a 8 weeks innovative training regime (stochastic resonance whole-body vibration \[SR-WBV\] and virtual virtual games \[VG\]) in the skilling up phase on physical performance and strength in elderly in need of care population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

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

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

March 31, 2014

Last Update Submit

July 14, 2016

Conditions

Poor Performance StatusMuscle Weakness

Outcome Measures

Primary Outcomes (1)

  • Physical 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.

    after 8 weeks

Secondary Outcomes (3)

  • Isometric maximum voluntary contraction (IMVC)

    after 8 weeks

  • Submaximal maximum voluntary contraction (subIMVC)

    after 8 weeks

  • Isometric rate of force development (IRFD)

    after 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (start with 3 up to 6 Hz, noise 4) T1 - intervention 4 weeks (SR-WBV (start with 3 up to 6Hz, noise 4 \& virtual games) - T2

Device: SR-WBVDevice: Virtual Games (VG)

Sham Comparator

SHAM COMPARATOR

T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 \& Aktiv Tramp) - T2

Other: SR-WBVDevice: Aktiv Tramp (Swiss Frei AG, Switzerland)

Interventions

SR-WBVDEVICE

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

Also known as: SRT Zeptor® med
Intervention group
Virtual Games (VG)DEVICE

Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.

Also known as: Virtual game board
Intervention group
Aktiv Tramp (Swiss Frei AG, Switzerland)DEVICE

Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.

Also known as: Mechanically controlled trampoline.
Sham Comparator

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)

  • Rogan S, Radlinger L, Baur H, Schmidtbleicher D, de Bie RA, de Bruin ED. Sensory-motor training targeting motor dysfunction and muscle weakness in long-term care elderly combined with motivational strategies: a single blind randomized controlled study. Eur Rev Aging Phys Act. 2016 May 28;13:4. doi: 10.1186/s11556-016-0164-0. eCollection 2016.

    PMID: 27239241RESULT

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heiner Baur, PhD

    BUAS

    PRINCIPAL INVESTIGATOR

  • Lorenz Radlinger, PhD

    Bern University of Applied Science, Department WGS

    STUDY DIRECTOR

  • Eling Douwe de Bruin, PhD

    Swiss Federal Institute of Technology

    STUDY DIRECTOR

  • Rob de Bie, Prof.

    Maastricht University Medical Center

    STUDY DIRECTOR

  • Dietmar Schmidtbleicher, Prof

    Goethe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

CH(1)