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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01679977
First received: September 3, 2012
Last updated: February 24, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated 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

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679977

Locations
Austria
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation Recruiting
Vienna, Austria, 1160
Contact: Hannah Fruhmann    0043149150 ext 3422    hannah.fruhmann@wienkav.at   
Principal Investigator: Helmut Kern, MD, PhD         
Slovakia
Facultiy of Physical Education and Sports, Comenius University of Bratislava Recruiting
Bratislava, Slovakia, 81806
Contact: Jan Cvecka, PhD    00421220669942    cvecka@fsport.uniba.sk   
Principal Investigator: Dusan Hamar, MD         
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:
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.

Additional 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
Study First Received: September 3, 2012
Last Updated: February 24, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

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

ClinicalTrials.gov processed this record on July 20, 2014