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 |
| Secondary identifying numbers | PI-PNP-_01_10 (sponsor), DJCLS R 09/22 (funder) |
- 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
Scientific
University Ulm Medical School
Department of Internal Medicine III
Ulm
89081
Germany
| richard.schlenk@uniklinik-ulm.de |
Dr Michael Brach
Scientific
Scientific
Institute of Sport Science
University of Muenster
-
-
Germany
| michael.brach@uni-muenster.de |
Dr Eva-Maria Panfil
Scientific
Scientific
Institute of Applied Nursing Sciences
St. Gallen University of Applied Sciences
-
-
Switzerland
| evamaria.panfil@fhsg.ch |
Dr Jörn Rittweger
Scientific
Scientific
Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
-
-
United Kingdom
| j.rittweger@mmu.ac.uk |
Study information
| Study design | Open-label single-centre randomised active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2010 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
89081
Germany
Sponsor information
University Ulm Medical School (Germany)
University/education
University/education
Nursing Management
Albert-Einstein-Allee 29
Ulm
89081
Germany
| Phone | +49 (0)731 50043055 |
|---|---|
| elisabeth.kirchner@uniklinikum-ulm.de | |
| Website | http://www.uniklinik-ulm.de/struktur/zentrale-einrichtungen/pflegedienst |
"ROR" |
https://ror.org/032000t02 |
Funders
Funder type
Industry
German Jose Carrera Leukaemia Foundation (Deutsche José Carrera Leukämie Stiftung e.V.) (Germany) - (DJCLS R 09/22)
No information available
NOVOTEC Medical GmbH (Germany)
No information available
Viv-Arte® Bewegungsschule (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
15/02/2017: Publication reference added.
