Completed
MOBILVibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness
What is being tested
Vibrational-proprioceptive Resistance Exercise Training
+ Neuromuscular Electrical Stimulation Training
Device
Who is being recruted
From 65 to 85 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: June 2008
Summary
Principal SponsorLudwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Last updated: March 7, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2008
Actual date on which the first participant was enrolled.Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two different types of training.
Principal SponsorLudwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Last updated: March 7, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 65 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
age between 65-85 years
age related muscle weakness
all inclusion criterias must be fullfilled
15 exclusion criteria prevent from participating
acute infection
acute thrombosis in lower extremity (within last 3 weeks)
body mass index greater than 40
dementia, impaired cognitive abilities
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorSubjects 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.
Group II
Active ComparatorES 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.
Group III
No InterventionThis group only perform the same measurements as the intervention groups and lives their live as usual in between.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Vienna, AustriaOpen Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation in Google MapsFacultiy of Physical Education and Sports, Comenius University of Bratislava
Bratislava, SlovakiaCompleted2 Study Centers