Poor Performance StatusNCT01713790
Innovative Training Methods for Frail Elderly in the Training Gain Stage
A study testing Stochastic resonance whole-body vibration, Exergame and Leg press in people with Poor Performance Status, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial summary
This study aims to examine long term effects in the training gain stage of the falls management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical functional performance after mechanical SR-WBV, dance therapy and strength training 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
- What is being tested?
- Stochastic resonance whole-body vibration, Exergame and Leg press
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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 Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance
This study aims to examine long term effects in the training gain stage of the falls management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical functional performance after mechanical SR-WBV, dance therapy and strength training 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, adapted measurement parameters for balance, strength and cognition will be used.
The goals of this study:
Evaluate the effects of
- functional lower extremity
- dynamic balance
- reaction time
- mobility
- muscle strength and cognition.
This is a one-group pre-post design study and the participants will be recruited in Canton Bern - Switzerland.
- Conditions
- Poor Performance Status
- Being tested
- Stochastic resonance whole-body vibration, Exergame, Leg press
- Keywords
- physical functional performance, postural balance, reaction time, mobility, muscle strength, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic resonance whole-body vibrationDevice
Also called SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.
ExergameDevice
Also called Virtual game board
training program over 10 weeks, three times a week.
Leg pressDevice
Also called Swiss Frei AG, Switzerland
training program over 10 weeks, three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | T0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - T1 Receives: Device: Stochastic resonance whole-body vibration; Device: Exergame; Device: Leg press |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPBB)
The SPBB assess lower extremity function at baseline and after a 10-week interventions period.
Measured: Change from baseline in SPBB at 10 weeks.
Secondary outcomes (7)
dynamic body balance
The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set. In the ETGUG test, times for the component tasks are measured at baseline and after a 10-week interventions period.
Measured: Change from baseline in dynamic body balance at 10 weeks.
walking in single (ST) and dual task (DT) conditions
- For the single task condition, the participants will be instructed to walk a distance of 20 meters at their self-selected walking speed. Total time were measured.
- For the dual task condition, the participant had to count backwards from the number 250 in steps of 7 while walking the same distance at their self-selected walking speed. Total walking times were measured.
- The time differences between the two tasks are evaluated at baseline and after a 10-week interventions period.
Measured: Change from baseline during walking in ST and DT condition at 10 weeks.
mobility
The participants using a StepWatch ™ Activity Monitor (SAM) pedometer. This digital pedometer record the total daily steps at baseline and after a 10-week interventions period.
Measured: Change from baseline in mobility at 10 weeks.
knee extension maximum voluntary contraction (MVC)
It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Measured: Change from baseline in knee extension MVC at 10 weeks.
knee extension rate of force develompent (RFD)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Measured: Change from baseline in knee extension RFD at 10 weeks.
knee flexion maximum voluntary contraction (MVC)
It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Measured: Change from baseline in knee flexion MVC at 10 weeks.
knee flexion rate of force develompent (RFD)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Measured: Change from baseline in knee flexion RFD at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology
- Responsible party
- Principal investigator, Heiner Baur (PhD), Bern University of Applied Sciences
- Investigators
- Slavko Rogan, MSc, Study chair, Bern University of Applied Science, Department WGSLorenz Radlinger, PhD, Study director, Bern University of Applied Science, Department WGSDietmar Schmidtbleicher, Prof., PhD, Study director, Johann Wolfgang Goethe University, Department Sport ScienceRob de Bie, Prof., PhD, Study director, University Maastricht, Department EpidemiologyEling D de Bruin, Prof., PhD, Study director, Swiss Federal Institute of Technology Zurich, Department Human Movement ScienceBaur Heiner, PhD, Principal investigator, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713790
- Sponsor's protocol ID
- Main study (PhD)- part II
- Status last verified
- Jul 2015
- First submitted
- 14 Oct 2012
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration With Stochastic Resonance and Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance
- ClinicalTrials.gov ID
- NCT01713790
- Acronym / sponsor ID
- Main study (PhD)- part II
- Conditions
- Poor Performance Status
- Keywords
- physical functional performance, postural balance, reaction time, mobility, muscle strength, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine long term effects in the training gain stage of the falls management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical functional performance after mechanical SR-WBV, dance therapy and strength training 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, adapted measurement parameters for balance, strength and cognition will be used.
The goals of this study:
Evaluate the effects of
- functional lower extremity
- dynamic balance
- reaction time
- mobility
- muscle strength and cognition.
This is a one-group pre-post design study and the participants will be recruited in Canton Bern - Switzerland.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Device: Stochastic resonance whole-body vibration, Device: Exergame, Device: Leg pressT0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - 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 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 |
|---|---|---|
| Stochastic resonance whole-body vibrationAlso: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4. | Device | Training group |
| ExergameAlso: Virtual game boardtraining program over 10 weeks, three times a week. | Device | Training group |
| Leg pressAlso: Swiss Frei AG, Switzerlandtraining program over 10 weeks, three times a week. | Device | Training group |
Primary outcome
Short Physical Performance Battery (SPBB)
Time frame: Change from baseline in SPBB at 10 weeks.
The SPBB assess lower extremity function at baseline and after a 10-week interventions period.
7 secondary outcomes
dynamic body balance
Time frame: Change from baseline in dynamic body balance at 10 weeks.
walking in single (ST) and dual task (DT) conditions
Time frame: Change from baseline during walking in ST and DT condition at 10 weeks.
mobility
Time frame: Change from baseline in mobility at 10 weeks.
knee extension maximum voluntary contraction (MVC)
Time frame: Change from baseline in knee extension MVC at 10 weeks.
knee extension rate of force develompent (RFD)
Time frame: Change from baseline in knee extension RFD at 10 weeks.
knee flexion maximum voluntary contraction (MVC)
Time frame: Change from baseline in knee flexion MVC at 10 weeks.
knee flexion rate of force develompent (RFD)
Time frame: Change from baseline in knee flexion RFD at 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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.
Slavko Rogan, MSc study chair
Bern University of Applied Science, Department WGS
Lorenz Radlinger, PhD study director
Bern University of Applied Science, Department WGS
Dietmar Schmidtbleicher, Prof., PhD study director
Johann Wolfgang Goethe University, Department Sport Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic resonance whole-body vibration, Exergame and Leg press in people with Poor Performance Status, 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 23 Jul 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short Physical Performance Battery (SPBB) (time frame: Change from baseline in SPBB at 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2015; AzTrials last refreshed its copy on 31 Oct 2026.