Effects of Galileo® vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function, motor action and muscular strength in patients with chemotherapy-related polyneuropathy [Auswirkungen des Galileo®-Vibrationstrainings als Zusatz zum pflegerischen Trainingskonzept des VivArte® Modells auf Bewegungssteuerung, Alltagsbewegungen, Alltagshandlungen und Muskelkraft bei Chemotherapie-Induzierter Polyneuropathie]

ISRCTN	ISRCTN51361937
DOI	https://doi.org/10.1186/ISRCTN51361937
Protocol serial number	PI-PNP-_01_10 (sponsor), DJCLS R 09/22 (funder)
Sponsor	University Ulm Medical School (Germany)
Funders	German Jose Carrera Leukaemia Foundation (Deutsche José Carrera Leukämie Stiftung e.V.) (Germany) - (DJCLS R 09/22), NOVOTEC Medical GmbH (Germany), Viv-Arte® Bewegungsschule (Germany)

Submission date: 25/08/2010
Registration date: 06/09/2010
Last edited: 15/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Schlenk
Scientific

University Ulm Medical School
Department of Internal Medicine III
Ulm
89081
Germany

Email	richard.schlenk@uniklinik-ulm.de

Dr Michael Brach
Scientific

Institute of Sport Science
University of Muenster
-
-
Germany

Email	michael.brach@uni-muenster.de

Dr Eva-Maria Panfil
Scientific

Institute of Applied Nursing Sciences
St. Gallen University of Applied Sciences
-
-
Switzerland

Email	evamaria.panfil@fhsg.ch

Dr Jörn Rittweger
Scientific

Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
-
-
United Kingdom

Email	j.rittweger@mmu.ac.uk

Study information

Primary study design	Interventional
Study design	Open-label single-centre randomised active controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of whole-body vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function and muscular strength: a randomised controlled trial in chemotherapy-related polyneuropathy
Study objectives	Based on a further development of kinesthetic nursing, Viv-Arte® Training conception (VAT) includes 1. Manual therapy 2. Gymnastic exercise 3. Functional training Whole-body vibration has proved to help persons who are bedridden or otherwise unable to exercise, maintaining muscular strength needed for activities of daily living. It is hypothised, that patients suffering from chemotherapy-related polyneuropathy could also benefit from whole-body vibration exercise, when added to VAT. Therefore, the trial at hand compares randomised groups treated with VAT versus VAT + whole-body vibration.
Ethics approval(s)	University of Ulm (Germany) Ethics Board, 25/05/2010, ref: 27/10 UBB/bal
Health condition(s) or problem(s) studied	Polyneuropathies, secondary to haematologic neoplasms and chemotherapy
Intervention	Control group and experimental group: 15 sessions (two per week) of 60 minutes each, containing VAT manual therapy and functional training. The latter will be skipped for patients who are not reliant upon personal assistance for mobility tasks (according to MOTPA, see secondary outcome measurements). Gymnastic exercise is instructed individually during the session, but should be conducted between sessions. Patients receive a diary and a pedometer for documentation of exercise including walking. Experimental group only: In each session, whole-body vibration exercise is integrated after manual therapy. Using a Galileo® training platform, a side-alternating motion similar to a seesaw movement is applied. Amplitude and frequency are variable and will be individually adjusted.
Intervention type	Other
Primary outcome measure(s)	Chair Rising Test (5 times standing up from a chair) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session
Key secondary outcome measure(s)	1. Bipedal jump test and balance test using a force plate (Leonardo® Mechanography) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 2. Functional mobility measured using motor tests including the Timed up and go test (TUG) and the Mobility test for patients in acute care (MOTPA) at baseline and 15th (last) exercise session 3. Quality of life, measured using the EORTC Quality of Life Core Questionnaire (QLQ-C30), Version 3.0, at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 4. Neurotoxicity, measured using the FACT/GOG Ntx (Funktional Assessment of Cancer Therapy/Gynecologie Onkcology Group - Neurotoxity) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session 5. Paresthesia, measured using the Visual Analogue Scale (VAS) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session 6. Sensory function, measured at baseline and 15th (last) exercise session, using a standardized quantitative sensory testing (QST) battery: 6.1. Thermal detection threshold, using a computer controlled thermode 6.2. Tactile detection threshold, using von-Frey hairs 6.3. Mechanical pain threshold/sensitivity for pinprick and for light touch, including wind-up (series) sensitivity 6.4. Vibration detection threshold, using a tuning fork 6.5. Pressure pain threshold, using a pressure algometer 7. In order to estimate velocity of nerve conduction as well as sensory and motor evoked potentials (SNAP, MEP), additional electrophysiological measurements will be taken on the discretion of the neurologist
Completion date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	122
Key inclusion criteria	1. Aged between 18 and 70 years 2. Polyneuropathy diagnosed (MeSH D011115) 3. Ongoing or finished chemotherapy due to hematologic neoplasms (MeSH D019337) 4. Contiguity between polyneuropathy and chemotherapy supposable 5. Chair Rising Test with pathological score (> 10 s) 6. Informed consent
Key exclusion criteria	1. Blood coagulation disorder 2. Infection beyond control 3. Thrombosis within 6 months before the trial 4. Severe neurological or psychiatric disorder, which might impair the validity of informed consent or the compliance with trial interventions 5. Epilepsy 6. Pregnacy
Date of first enrolment	01/07/2010
Date of final enrolment	30/06/2014

Locations

Countries of recruitment

Germany

Study participating centre

University Ulm Medical School

Ulm
89081
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/02/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/02/2017: Publication reference added.