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

NCT ID: NCT01679977

Last Updated: 2016-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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Conditions

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Muscle Weakness Condition Therapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Vibrational-proprioceptive Resistance Exercise Training

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Neuromuscular Electrical Stimulation Training

Intervention Type DEVICE

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vibrational-proprioceptive Resistance Exercise Training

Intervention Type DEVICE

Neuromuscular Electrical Stimulation Training

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age related muscle weakness
* age between 65-85 years

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Union

OTHER

Sponsor Role collaborator

Ministry of Science and Research, Austria

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Comenius University

OTHER

Sponsor Role collaborator

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

OTHER

Sponsor Role lead

Responsible Party

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Helmut Kern, MD PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helmut Kern, MD PhD

Role: STUDY_CHAIR

Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Locations

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Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation

Vienna, , Austria

Site Status

Facultiy of Physical Education and Sports, Comenius University of Bratislava

Bratislava, , Slovakia

Site Status

Countries

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Austria Slovakia

References

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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.

Reference Type BACKGROUND
PMID: 22196751 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35234026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26471138 (View on PubMed)

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.

Reference Type RESULT
PMID: 21401669 (View on PubMed)

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.

Reference Type RESULT
PMID: 24149637 (View on PubMed)

Kern H, Loefler S, Hofer C, Vogelauer M, Burggraf S, Grim-Stieger M, Cvecka J, Hamar D, Sarabon N, Protasi F, MusarĂ² 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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 23566634 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT

Kern H, Loefler S, Burggraf S, Fruhmann H, Cvecka J, Sedliak M, Barberi L, De Rossi M, MusarĂ² 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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 24042616 (View on PubMed)

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.

Reference Type RESULT
PMID: 24550352 (View on PubMed)

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.

Reference Type RESULT
PMID: 24607961 (View on PubMed)

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.

Reference Type RESULT
PMID: 25104935 (View on PubMed)

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.

Reference Type RESULT
PMID: 26913164 (View on PubMed)

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.

Reference Type RESULT
PMID: 26913162 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28078066 (View on PubMed)

Other Identifiers

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MOBIL

Identifier Type: -

Identifier Source: org_study_id

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