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Vibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness (MOBIL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679977
First Posted: September 6, 2012
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
European Union
Ministry of Science and Research, Austria
Medical University of Vienna
Comenius University
Information provided by (Responsible Party):
Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
  Purpose
Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.

Condition Intervention
Muscle Weakness Condition Therapy Effect Device: Vibrational-proprioceptive Resistance Exercise Training Device: Neuromuscular Electrical Stimulation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation:

Primary Outcome Measures:
  • Maximum voluntary knee extension torque [ Time Frame: pre Training, post Training, 3 months post training ]

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Legpress
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.
Device: Vibrational-proprioceptive Resistance Exercise Training
Active Comparator: E-Stim
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.
Device: Neuromuscular Electrical Stimulation Training
No Intervention: Control
This group only perform the same measurements as the intervention groups and lives their live as usual in between.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age related muscle weakness
  • age between 65-85 years
  • all inclusion criterias must be fullfilled

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679977


Locations
Austria
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Vienna, Austria, 1160
Slovakia
Facultiy of Physical Education and Sports, Comenius University of Bratislava
Bratislava, Slovakia, 81806
Sponsors and Collaborators
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
European Union
Ministry of Science and Research, Austria
Medical University of Vienna
Comenius University
Investigators
Study Chair: Helmut Kern, MD PhD Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
  More Information

Additional Information:
Publications:
Krenn 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.
Nejc 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.
Kern 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.
Sarabon 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 Sep 7. pii: /j/bmte.2013.58.issue-s1-A/bmt-2013-4006/bmt-2013-4006.xml. doi: 10.1515/bmt-2013-4006. [Epub ahead of print]
Zampieri S, Pietrangelo L, Loefler S, Fruhmann H, Vogelauer M, Burggraf S, Pond A, Grim-Stieger M, Cvecka J, Sedliak M, Tirpáková V, Mayr W, Sarabon N, Rossini K, Barberi L, De Rossi M, Romanello V, Boncompagni S, Musarò 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.
Mosole 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, Musarò 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.
Kern H, Barberi L, Löfler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014.
Cvecka J, Tirpakova V, Sedliak M, Kern H, Mayr W, Hamar D. Physical Activity in Elderly. Eur J Transl Myol. 2015 Aug 25;25(4):249-52. doi: 10.4081/ejtm.2015.5280. eCollection 2015 Aug 24. Review.
Zampieri S, Mosole S, Löfler S, Fruhmann H, Burggraf S, Cvečka J, Hamar D, Sedliak M, Tirptakova V, Šarabon N, Mayr W, Kern H. Physical Exercise in Aging: Nine Weeks of Leg Press or Electrical Stimulation Training in 70 Years Old Sedentary Elderly People. Eur J Transl Myol. 2015 Aug 25;25(4):237-42. doi: 10.4081/ejtm.2015.5374. eCollection 2015 Aug 24. Review.
Kern H, Pelosi L, Coletto L, Musarò A, Sandri M, Vogelauer M, Trimmel L, Cvecka J, Hamar D, Kovarik J, Löfler 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.
Sarabon 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, Löfler S, Fruhmann H, Vogelauer M, Burggraf S, Grim-Stieger M, Cvečka J, Hamar D, Sedliak M, Šarabon 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. Eur J of Trans Myol 23(4):205-210, 2013.
Vargas Luna JL, Krenn M, Löfler S, Kern H, Cortés 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helmut Kern, MD PhD, MD, PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
ClinicalTrials.gov Identifier: NCT01679977     History of Changes
Other Study ID Numbers: MOBIL
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: March 7, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms


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