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

Muscle Weakness Condition Clinical Trial

— MOBIL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679977
• Other study ID #: MOBIL
• Status: Completed
• Phase: N/A
• First received: September 3, 2012
• Last updated: March 4, 2016
• Start date: June 2008
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Muscle Weakness Condition
• Paresis
• Therapy Effect

Intervention

Device:
• Vibrational-proprioceptive Resistance Exercise Training

• Neuromuscular Electrical Stimulation Training

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation	Vienna
Slovakia	Facultiy of Physical Education and Sports, Comenius University of Bratislava	Bratislava

Sponsors (5)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation	Comenius University, European Union, Medical University of Vienna, Ministry of Science and Research, Austria

Countries where clinical trial is conducted

Austria,  Slovakia, 

References & Publications (18)

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. — View Citation

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: 10.15 — View Citation

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 decl — View Citation

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, 20

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 mobil

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. — View Citation

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. — View Citation

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 exerci — View Citation

Mosole S, Rossini K, Kern H, Löfler S, Fruhmann H, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka 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.

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. — View Citation

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.

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.

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. — View Citation

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.

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.

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. — View Citation

Zampieri S, Mosole S, Löfler S, Fruhmann H, Burggraf S, Cvecka 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. — View Citation

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, — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum voluntary knee extension torque		pre Training, post Training, 3 months post training	No

External Links

•   Click here for more information about this study: Clinical trials of different training protocols in elderly with muscle weakness