Muscle Weakness ConditionMOBILNCT01679977
Vibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness
A study testing Vibrational-proprioceptive Resistance Exercise Training and Neuromuscular Electrical Stimulation Training in people with Muscle Weakness Condition and Therapy Effect, run by Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation at 2 sites in 2 countries.
Trial summary
Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness Condition, Therapy Effect
- What is being tested?
- Vibrational-proprioceptive Resistance Exercise Training and Neuromuscular Electrical Stimulation Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Mar 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age related muscle weakness
- age between 65-85 years
- all inclusion criterias must be fullfilled
Who cannot join
- recent hip or knee endp-prosthesis (within last 2 years), longstanding immobility
- body mass index greater than 40
- acute thrombosis in lower extremity (within last 3 weeks)
- severe articular effusion
- acute infection
- known myopathy
Show all 15Show fewer
- relevant neurological diseases with gait disorders (e.g. poly neuropathy, Parkinson's disease)
- dementia, impaired cognitive abilities
- diseases of the vestibular system causing vertigo or impairing balance
- symptomatic cardio pulmonal diseases within the last 6 months
- not or insufficient treated hypertonia
- rheumatic diseases
- other relevant functional impairment of the musculo-skeletal system caused by surgery, trauma or degenerative diseases
- pain in the lower extremity (VAS > 5)
- if one of the above criteria applies the subject will be excluded from the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Vienna, 1160
Slovakia1 site
Facultiy of Physical Education and Sports, Comenius University of Bratislava
Bratislava, 81806
About this study
Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.
- Conditions
- Muscle Weakness Condition, Therapy Effect
- Being tested
- Vibrational-proprioceptive Resistance Exercise Training, Neuromuscular Electrical Stimulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrational-proprioceptive Resistance Exercise TrainingDevice
Neuromuscular Electrical Stimulation TrainingDevice
| Study group | Role | What they receive |
|---|---|---|
| Legpress | Active comparator | Subjects in the LP group train on a custom built, computer controlled, linear electric motor powered leg press device. The so called "swinging" vibrational-proprioceptive mode is used, which means that constant velocity of the pedals (0.3 m/s and 0.2 m/s for concentric and eccentric phase, respectively) are interrupted by short stops (every 8 mm), resulting in short force peaks appearing throughout the movement. Training load is progressively increased throughout the training. Receives: Device: Vibrational-proprioceptive Resistance Exercise Training |
| E-Stim | Active comparator | ES training is performed with a custom-built battery-powered stimulator. The subject are seated over the edge of the therapeutic table with the trunk upright and lower legs freely swinging. Two conductive rubber electrodes covered by wet sponge are placed on the anterior thigh on each side of the body. The electrode pairs are connected to the independent channels of the stimulator and the left and the right thigh are stimulated in an alternative manner. Each repetition (i.e. ES evoked muscle contraction) is evoked by a 3.5 s train (60 Hz) of electrical pulses (rectangular, biphasic, width 0.6 ms). Consecutive contractions of the same thigh are separated by 4.5 s off intervals. Maximal tolerable intensity should be used and is monitored during the training sessions. In all the subjects this should induce a tetanic contraction of the stimulated muscles. Receives: Device: Neuromuscular Electrical Stimulation Training |
| Control | No intervention | This group only perform the same measurements as the intervention groups and lives their live as usual in between. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary knee extension torque
Measured: pre Training, post Training, 3 months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJun 2008
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Muscle Weakness ConditionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Ministry of Science and Research, Austria, Medical University of Vienna, Comenius University
- Responsible party
- Principal investigator, Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
- Investigators
- Helmut Kern, MD PhD, Study chair, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679977
- Sponsor's protocol ID
- MOBIL
- Acronym
- MOBIL
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2012
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kern H, Pelosi L, Coletto L, Musaro A, Sandri M, Vogelauer M, Trimmel L, Cvecka J, Hamar D, Kovarik J, Lofler S, Sarabon N, Protasi F, Adami N, Biral D, Zampieri S, Carraro U. Atrophy/hypertrophy cell signaling in muscles of young athletes trained with vibrational-proprioceptive stimulation. Neurol Res. 2011 Dec;33(10):998-1009. doi: 10.1179/016164110X12767786356633.
PubMed 22196751Sarabon N, Zacirkovnik T, Rosker J, Loefler S. Metric Characteristics of the Tests for Dynamic Balance Evaluation. Phys Med Rehab Kuror. 23(03):135-46, 2013.
Sarabon N, Rosker J, Fruhmann H, Burggraf S, Loefler S, Kern H. Reliability of maximal voluntary contraction related parameters measured by a portable isometric knee dynamometer. Phys Med Rehab Kuror. 23(01):22-27, 2013.
Mosole S, Rossini K, Kern H, Lofler S, Fruhmann H, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sedliak M, Sarabon N, Pond A, Biral D, Carraro U, Zampieri S. Reinnervation of Vastus lateralis is increased significantly in seniors (70-years old) with a lifelong history of high-level exercise (2013, revisited here in 2022). Eur J Transl Myol. 2022 Feb 28;32(1):10420. doi: 10.4081/ejtm.2022.10420.
PubMed 35234026Vargas Luna JL, Krenn M, Lofler S, Kern H, Cortes R JA, Mayr W. Comparison of Twitch Responses During Current- or Voltage-Controlled Transcutaneous Neuromuscular Electrical Stimulation. Artif Organs. 2015 Oct;39(10):868-75. doi: 10.1111/aor.12623.
PubMed 26471138Krenn M, Haller M, Bijak M, Unger E, Hofer C, Kern H, Mayr W. Safe neuromuscular electrical stimulator designed for the elderly. Artif Organs. 2011 Mar;35(3):253-6. doi: 10.1111/j.1525-1594.2011.01217.x.
PubMed 21401669Nejc S, Jernej R, Loefler S, Kern H. Sensitivity of body sway parameters during quiet standing to manipulation of support surface size. J Sports Sci Med. 2010 Sep 1;9(3):431-8. eCollection 2010.
PubMed 24149637Kern H, Loefler S, Hofer C, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sarabon N, Protasi F, Musarò A, Sandri M, Rossini K, Carraro U, Zampieri S. FES Training in Aging: interim results show statistically significant improvements in mobility and muscle fiber size. European Journal Translational Myology - Basic Applied Myology 22(1&2):61-67, 2012.
Sarabon N, Rosker J, Loefler S, Kern H. The effect of vision elimination during quiet stance tasks with different feet positions. Gait Posture. 2013 Sep;38(4):708-11. doi: 10.1016/j.gaitpost.2013.03.005. Epub 2013 Apr 6.
PubMed 23566634Sarabon N, Loefler S, Cvecka J, Sedliak M, Kern H. Strength training in elderly people improves static balance: a randomized controlled trial. European Journal of Translational Myology - Basic Applied Myology 23(3):85-89, 2013.
Sedliak M, Cvecka J, Tirpakova V, Loefler S, Sarabon S, Kern H, Hamar D. Reliability of novel postural sway task test. European Journal of Translational Myology - Basic Applied Myology 23(3):81-84, 2013.
Kern H, Loefler S, Burggraf S, Fruhmann H, Cvecka J, Sedliak M, Barberi L, De Rossi M, Musarò A, Carraro U, Mosole S, Zampieri S. Elektrostimulation verhindert die Altersbedingte Atrophie der Muskulatur beim Menschen. Eur J of Trans Myol 23(3):105-108, 2013.
Hendling M, Krenn M, Haller MA, Loefler S, Kern H, Mayr W. Compliance monitoring of home based electrical stimulation training of elderly subjects. Biomed Tech (Berl). 2013 Aug;58 Suppl 1:/j/bmte.2013.58.issue-s1-A/bmt-2013-4006/bmt-2013-4006.xml. doi: 10.1515/bmt-2013-4006. Epub 2013 Sep 7. No abstract available.
PubMed 24042616Zampieri S, Pietrangelo L, Loefler S, Fruhmann H, Vogelauer M, Burggraf S, Pond A, Grim-Stieger M, Cvecka J, Sedliak M, Tirpakova V, Mayr W, Sarabon N, Rossini K, Barberi L, De Rossi M, Romanello V, Boncompagni S, Musaro A, Sandri M, Protasi F, Carraro U, Kern H. Lifelong physical exercise delays age-associated skeletal muscle decline. J Gerontol A Biol Sci Med Sci. 2015 Feb;70(2):163-73. doi: 10.1093/gerona/glu006. Epub 2014 Feb 18.
PubMed 24550352Mosole S, Carraro U, Kern H, Loefler S, Fruhmann H, Vogelauer M, Burggraf S, Mayr W, Krenn M, Paternostro-Sluga T, Hamar D, Cvecka J, Sedliak M, Tirpakova V, Sarabon N, Musaro A, Sandri M, Protasi F, Nori A, Pond A, Zampieri S. Long-term high-level exercise promotes muscle reinnervation with age. J Neuropathol Exp Neurol. 2014 Apr;73(4):284-94. doi: 10.1097/NEN.0000000000000032.
PubMed 24607961
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness
- ClinicalTrials.gov ID
- NCT01679977
- Acronym / sponsor ID
- MOBIL / MOBIL
- Conditions
- Muscle Weakness Condition, Therapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute of Electrical Stimulation and Physical RehabilitationUniversity, hospital or other
- Collaborators
- European Union, Ministry of Science and Research, Austria, Medical University of Vienna, Comenius University
- Study start
- Jun 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Sep 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.
Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Legpress | Active comparator | Device: Vibrational-proprioceptive Resistance Exercise TrainingSubjects in the LP group train on a custom built, computer controlled, linear electric motor powered leg press device. The so called "swinging" vibrational-proprioceptive mode is used, which means that constant velocity of the pedals (0.3 m/s and 0.2 m/s for concentric and eccentric phase, respectively) are interrupted by short stops (every 8 mm), resulting in short force peaks appearing throughout the movement. Training load is progressively increased throughout the training. |
| E-Stim | Active comparator | Device: Neuromuscular Electrical Stimulation TrainingES training is performed with a custom-built battery-powered stimulator. The subject are seated over the edge of the therapeutic table with the trunk upright and lower legs freely swinging. Two conductive rubber electrodes covered by wet sponge are placed on the anterior thigh on each side of the body. The electrode pairs are connected to the independent channels of the stimulator and the left and the right thigh are stimulated in an alternative manner. Each repetition (i.e. ES evoked muscle contraction) is evoked by a 3.5 s train (60 Hz) of electrical pulses (rectangular, biphasic, width 0.6 ms). Consecutive contractions of the same thigh are separated by 4.5 s off intervals. Maximal tolerable intensity should be used and is monitored during the training sessions. In all the subjects this should induce a tetanic contraction of the stimulated muscles. |
| Control | No intervention | –This group only perform the same measurements as the intervention groups and lives their live as usual in between. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age related muscle weakness
- age between 65-85 years
- all inclusion criterias must be fullfilled
Key exclusion criteria (15 listed)
- recent hip or knee endp-prosthesis (within last 2 years), longstanding immobility
- body mass index greater than 40
- acute thrombosis in lower extremity (within last 3 weeks)
- severe articular effusion
- acute infection
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 |
|---|---|---|
| Vibrational-proprioceptive Resistance Exercise Training | Device | Legpress |
| Neuromuscular Electrical Stimulation Training | Device | E-Stim |
Primary outcome
Maximum voluntary knee extension torque
Time frame: pre Training, post Training, 3 months post training
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 7 Mar 2016.
- Background: PubMed 22196751Kern H, Pelosi L, Coletto L, Musaro A, Sandri M, Vogelauer M, Trimmel L, Cvecka J, Hamar D, Kovarik J, Lofler S, Sarabon N, Protasi F, Adami N, Biral D, Zampieri S, Carraro U. Atrophy/hypertrophy cell signaling in muscles of young athletes trained with vibrational-proprioceptive stimulation. Neurol Res. 2011 Dec;33(10):998-1009. doi: 10.1179/016164110X12767786356633.
- BackgroundSarabon N, Zacirkovnik T, Rosker J, Loefler S. Metric Characteristics of the Tests for Dynamic Balance Evaluation. Phys Med Rehab Kuror. 23(03):135-46, 2013.
- BackgroundSarabon N, Rosker J, Fruhmann H, Burggraf S, Loefler S, Kern H. Reliability of maximal voluntary contraction related parameters measured by a portable isometric knee dynamometer. Phys Med Rehab Kuror. 23(01):22-27, 2013.
- Background: PubMed 35234026Mosole S, Rossini K, Kern H, Lofler S, Fruhmann H, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sedliak M, Sarabon N, Pond A, Biral D, Carraro U, Zampieri S. Reinnervation of Vastus lateralis is increased significantly in seniors (70-years old) with a lifelong history of high-level exercise (2013, revisited here in 2022). Eur J Transl Myol. 2022 Feb 28;32(1):10420. doi: 10.4081/ejtm.2022.10420.
- Background: PubMed 26471138Vargas Luna JL, Krenn M, Lofler S, Kern H, Cortes R JA, Mayr W. Comparison of Twitch Responses During Current- or Voltage-Controlled Transcutaneous Neuromuscular Electrical Stimulation. Artif Organs. 2015 Oct;39(10):868-75. doi: 10.1111/aor.12623.
- Results publication: PubMed 21401669Krenn M, Haller M, Bijak M, Unger E, Hofer C, Kern H, Mayr W. Safe neuromuscular electrical stimulator designed for the elderly. Artif Organs. 2011 Mar;35(3):253-6. doi: 10.1111/j.1525-1594.2011.01217.x.
- Results publication: PubMed 24149637Nejc S, Jernej R, Loefler S, Kern H. Sensitivity of body sway parameters during quiet standing to manipulation of support surface size. J Sports Sci Med. 2010 Sep 1;9(3):431-8. eCollection 2010.
- Results publicationKern H, Loefler S, Hofer C, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sarabon N, Protasi F, Musarò A, Sandri M, Rossini K, Carraro U, Zampieri S. FES Training in Aging: interim results show statistically significant improvements in mobility and muscle fiber size. European Journal Translational Myology - Basic Applied Myology 22(1&2):61-67, 2012.
- Results publication: PubMed 23566634Sarabon N, Rosker J, Loefler S, Kern H. The effect of vision elimination during quiet stance tasks with different feet positions. Gait Posture. 2013 Sep;38(4):708-11. doi: 10.1016/j.gaitpost.2013.03.005. Epub 2013 Apr 6.
- Results publicationSarabon N, Loefler S, Cvecka J, Sedliak M, Kern H. Strength training in elderly people improves static balance: a randomized controlled trial. European Journal of Translational Myology - Basic Applied Myology 23(3):85-89, 2013.
- Results publicationSedliak M, Cvecka J, Tirpakova V, Loefler S, Sarabon S, Kern H, Hamar D. Reliability of novel postural sway task test. European Journal of Translational Myology - Basic Applied Myology 23(3):81-84, 2013.
- Results publicationKern H, Loefler S, Burggraf S, Fruhmann H, Cvecka J, Sedliak M, Barberi L, De Rossi M, Musarò A, Carraro U, Mosole S, Zampieri S. Elektrostimulation verhindert die Altersbedingte Atrophie der Muskulatur beim Menschen. Eur J of Trans Myol 23(3):105-108, 2013.
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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.
Helmut Kern, MD PhD study chair
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrational-proprioceptive Resistance Exercise Training and Neuromuscular Electrical Stimulation Training in people with Muscle Weakness Condition and Therapy Effect, run by Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation at 2 sites in 2 countries.
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 15 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Slovakia. 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?
Maximum voluntary knee extension torque (time frame: pre Training, post Training, 3 months post training). 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 NCT01679977, which also lists 19 linked publications.
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 7 Mar 2016; AzTrials last refreshed its copy on 1 Nov 2026.