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

March 4, 2016 updated by: Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1160
        • Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
  • Slovakia
      • Bratislava, Slovakia, 81806
        • Facultiy of Physical Education and Sports, Comenius University of Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum voluntary knee extension torque
Time Frame: pre Training, post Training, 3 months post training
pre Training, post Training, 3 months post training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Collaborators

Medical University of Vienna
European Union
Comenius University
Ministry of Science and Research, Austria

Investigators

  • Study Chair: Helmut Kern, MD PhD, Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOBIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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