Poor Performance StatusNCT01704976
SR-WBV Training for Frail Elderly in the Skilling up Stage
A study testing SR-WBV in people with Poor Performance Status and Muscle Weakness, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poor Performance Status, Muscle Weakness
- What is being tested?
- SR-WBV
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- RAI (Resident Assessment Instrument) >0
- live in canton Bern
- in terms of training load be resistant.
Who cannot join
- 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
Show all 9Show fewer
- severe migraine
- epilepsy
- acute severe pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
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.
Read the 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:
- Feasibility
- Study the effect on physical functional performance
- 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
- Being tested
- SR-WBV
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-WBVDevice
Also called SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland), Intervention-Group
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
SR-WBVDevice
Also called SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1 Receives: 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 Receives: Device: SR-WBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: after 4 weeks
Secondary outcomes (4)
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Measured: after 4 weeks
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
Measured: after 4 weeks
Isometric Rate of Force Development (IRFD) Right Knee-extensor
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Measured: after 4 weeks
Isometric Rate of Force Development (IRFD) Left Knee-extensor
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poor Performance StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slavko Rogan, Bern University of Applied Sciences
- Investigators
- Rogan Slavko, MSc, Study chair, Bern University of Applied Science, Department WGSRadlinger Lorenz, PhD, Study director, Bern University of Applied Science, Department WGSBaur Heiner, PhD, Principal investigator, Bern University of Applied SciencesJessica Kessler, MSc, Study chair, BUAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704976
- Sponsor's protocol ID
- MSc-study (Biel)
- Status last verified
- Jan 2019
- First submitted
- 7 Oct 2012
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25042993
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
- ClinicalTrials.gov ID
- NCT01704976
- Acronym / sponsor ID
- MSc-study (Biel)
- Conditions
- Poor Performance Status, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Posted 24 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Feasibility
- Study the effect on physical functional performance
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: SR-WBVT0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1 |
| Sham group | Sham comparator | Device: SR-WBVT0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- RAI (Resident Assessment Instrument) >0
- live in canton Bern
- in terms of training load be resistant.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR-WBVAlso: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland), Intervention-GroupParticipants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4. | Device | Intervention |
| SR-WBVAlso: SRT Zeptor® med plus Noise (Swiss Frei AG, SwitzerlandParticipants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1. | Device | Sham group |
Primary outcome
Physical Functional Performance
Time frame: 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".
4 secondary outcomes
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Time frame: after 4 weeks
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
Time frame: after 4 weeks
Isometric Rate of Force Development (IRFD) Right Knee-extensor
Time frame: after 4 weeks
Isometric Rate of Force Development (IRFD) Left Knee-extensor
Time frame: after 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25042993Kessler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogan Slavko, MSc study chair
Bern University of Applied Science, Department WGS
Radlinger Lorenz, PhD study director
Bern University of Applied Science, Department WGS
Baur Heiner, PhD principal investigator
Bern University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SR-WBV in people with Poor Performance Status and Muscle Weakness, run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functional Performance (time frame: after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.