Poor Performance StatusPhase 4NCT02102919
Innovative Training Program for Elderly in Need of Care Individuals
A Phase 4 study testing SR-WBV, Virtual Games (VG) and Aktiv Tramp (Swiss Frei AG, Switzerland) in people with Poor Performance Status and Muscle Weakness, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial 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. 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, Virtual Games (VG) and Aktiv Tramp (Swiss Frei AG, Switzerland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Feb 2015
- Phase
- Phase 4
- 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 lower limb
- acute inflammation or infection tumors
Show all 9Show fewer
- fresh surgical wounds
- severe migraine
- epilepsy acute severe pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skilling-up Exercise for Elderly in Need of Care
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.
Read the detailed description
Sensorimotor and strength exercise are methods to increase strength \& power in the field of geriatrics. The question that arise what exercises are best suited to and most effective for elderly in need of care individuals. Such populations are advised first to enter a "skilling up program" before more traditional forms of training exercises are implemented.
Goals in the skilling up phase: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
The aim of the study in the skilling up phase:
Study the effect on physical performance Study the effects on muscle strength.. The participants will be recruited in Canton Bern - Switzerland and will be randomly allocated to an intervention group or sham group.
- Conditions
- Poor Performance Status, Muscle Weakness
- Being tested
- SR-WBV, Virtual Games (VG), Aktiv Tramp (Swiss Frei AG, Switzerland)
- 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
Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
Virtual Games (VG)Device
Also called Virtual game board
Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
SR-WBVOther
Also called SRT Zeptor® med
Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
Aktiv Tramp (Swiss Frei AG, Switzerland)Device
Also called Mechanically controlled trampoline.
Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SR-WBV; Device: 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 Receives: Other: SR-WBV; Device: Aktiv Tramp (Swiss Frei AG, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 8 weeks
Secondary outcomes (3)
Isometric maximum voluntary contraction (IMVC)
It will be evaluated by isometric MCV at 90 degree angle in the knee joint.
Measured: after 8 weeks
Submaximal maximum voluntary contraction (subIMVC)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
Measured: after 8 weeks
Isometric rate of force development (IRFD)
It will be evaluated by isometric RFD at 90 degree angle in the knee joint.
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- Heiner Baur, PhD, Principal investigator, BUASLorenz Radlinger, PhD, Study director, Bern University of Applied Science, Department WGSEling Douwe de Bruin, PhD, Study director, Swiss Federal Institute of TechnologyRob de Bie, Prof., Study director, Maastricht University Medical CenterDietmar Schmidtbleicher, Prof, Study director, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102919
- Sponsor's protocol ID
- Main study (PhD)- part I
- Status last verified
- Jul 2016
- First submitted
- 31 Mar 2014
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27239241
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skilling-up Exercise for Elderly in Need of Care
- ClinicalTrials.gov ID
- NCT02102919
- Acronym / sponsor ID
- Main study (PhD)- part I
- Conditions
- Poor Performance Status, Muscle Weakness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Apr 2014 (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.
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.
Detailed description
Sensorimotor and strength exercise are methods to increase strength \& power in the field of geriatrics. The question that arise what exercises are best suited to and most effective for elderly in need of care individuals. Such populations are advised first to enter a "skilling up program" before more traditional forms of training exercises are implemented.
Goals in the skilling up phase: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
The aim of the study in the skilling up phase:
Study the effect on physical performance Study the effects on muscle strength.. The participants will be recruited in Canton Bern - Switzerland 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 group | Experimental | Device: SR-WBV, Device: Virtual Games (VG)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 |
| Sham Comparator | Sham comparator | Other: SR-WBV, Device: Aktiv Tramp (Swiss Frei AG, Switzerland)T0 - intervention 4 weeks (SR-WBV 1 Hz, noise 1) - T1 - intervention 4 weeks (SR-WBV 1 Hz, noise 1 \& Aktiv Tramp) - T2 |
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
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® medParticipants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4. | Device | Intervention group |
| Virtual Games (VG)Also: Virtual game boardParticipants will undergo a training program set from week 5 to 8, three times a week over 20 minutes. | Device | Intervention group |
| SR-WBVAlso: SRT Zeptor® medParticipants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1. | Other | Sham Comparator |
| Aktiv Tramp (Swiss Frei AG, Switzerland)Also: Mechanically controlled trampoline.Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz. | Device | Sham Comparator |
Primary outcome
Physical performance
Time frame: after 8 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.
3 secondary outcomes
Isometric maximum voluntary contraction (IMVC)
Time frame: after 8 weeks
Submaximal maximum voluntary contraction (subIMVC)
Time frame: after 8 weeks
Isometric rate of force development (IRFD)
Time frame: after 8 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 15 Jul 2016.
- Results publication: PubMed 27239241Rogan 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.
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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.
Heiner Baur, PhD principal investigator
BUAS
Lorenz Radlinger, PhD study director
Bern University of Applied Science, Department WGS
Eling Douwe de Bruin, PhD study director
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SR-WBV, Virtual Games (VG) and Aktiv Tramp (Swiss Frei AG, Switzerland) 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 15 Jul 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical performance (time frame: after 8 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 NCT02102919, 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 15 Jul 2016.