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

Primary Purpose

Muscle Weakness Condition, Therapy Effect

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Vibrational-proprioceptive Resistance Exercise Training

Neuromuscular Electrical Stimulation Training

About this trial

This is an interventional treatment trial for Muscle Weakness Condition

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Facultiy of Physical Education and Sports, Comenius University of Bratislava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Legpress

E-Stim

Control

Arm Description

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.

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.

This group only perform the same measurements as the intervention groups and lives their live as usual in between.

Outcomes

Primary Outcome Measures

Maximum voluntary knee extension torque

Secondary Outcome Measures

Full Information

NCT ID

NCT01679977

First Posted

September 3, 2012

Last Updated

March 4, 2016

Sponsor

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01679977

Brief Title

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

Acronym

MOBIL

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Weakness Condition, Therapy Effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Legpress

Arm Type

Active Comparator

Arm Description

Arm Title

E-Stim

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

This group only perform the same measurements as the intervention groups and lives their live as usual in between.

Intervention Type

Device

Intervention Name(s)

Vibrational-proprioceptive Resistance Exercise Training

Intervention Type

Device

Intervention Name(s)

Neuromuscular Electrical Stimulation Training

Primary Outcome Measure Information:

Title

Maximum voluntary knee extension torque

Time Frame

pre Training, post Training, 3 months post training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helmut Kern, MD PhD

Organizational Affiliation

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Official's Role

Study Chair

Facility Information:

Facility Name

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

City

Vienna

ZIP/Postal Code

1160

Country

Austria

Facility Name

Facultiy of Physical Education and Sports, Comenius University of Bratislava

City

Bratislava

ZIP/Postal Code

81806

Country

Slovakia

12. IPD Sharing Statement

Citations:

PubMed Identifier

22196751

Citation

Kern H, Pelosi L, Coletto L, Musaro A, Sandri M, Vogelauer M, Trimmel L, Cvecka J, Hamar D, Kovarik J, Lofler 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.

Results Reference

background

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

35234026

Citation

Mosole S, Rossini K, Kern H, Lofler S, Fruhmann H, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sedliak M, Sarabon 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 (2013, revisited here in 2022). Eur J Transl Myol. 2022 Feb 28;32(1):10420. doi: 10.4081/ejtm.2022.10420.

Results Reference

background

PubMed Identifier

26471138

Citation

Vargas Luna JL, Krenn M, Lofler S, Kern H, Cortes 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.

Results Reference

background

PubMed Identifier

21401669

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.

Results Reference

result

PubMed Identifier

24149637

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

23566634

Citation

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.

Results Reference

result

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.

Results Reference

result

Citation

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.

Results Reference

result

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, 2013.

Results Reference

result

PubMed Identifier

24042616

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 Aug;58 Suppl 1:/j/bmte.2013.58.issue-s1-A/bmt-2013-4006/bmt-2013-4006.xml. doi: 10.1515/bmt-2013-4006. Epub 2013 Sep 7. No abstract available.

Results Reference

result

PubMed Identifier

24550352

Citation

Zampieri S, Pietrangelo L, Loefler S, Fruhmann H, Vogelauer M, Burggraf S, Pond A, Grim-Stieger M, Cvecka J, Sedliak M, Tirpakova V, Mayr W, Sarabon N, Rossini K, Barberi L, De Rossi M, Romanello V, Boncompagni S, Musaro 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.

Results Reference

result

PubMed Identifier

24607961

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, Musaro 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.

Results Reference

result

PubMed Identifier

25104935

Citation

Kern H, Barberi L, Lofler 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.

Results Reference

result

PubMed Identifier

26913164

Citation

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.

Results Reference

result

PubMed Identifier

26913162

Citation

Zampieri S, Mosole S, Lofler S, Fruhmann H, Burggraf S, Cvecka J, Hamar D, Sedliak M, Tirptakova V, Sarabon 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.

Results Reference

result

PubMed Identifier

28078066

Citation

Mosole S, Carraro U, Kern H, Loefler S, Zampieri S. Use it or Lose It: Tonic Activity of Slow Motoneurons Promotes Their Survival and Preferentially Increases Slow Fiber-Type Groupings in Muscles of Old Lifelong Recreational Sportsmen. Eur J Transl Myol. 2016 Nov 25;26(4):5972. doi: 10.4081/ejtm.2016.5972. eCollection 2016 Sep 15.

Results Reference

derived

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

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