Impact of a pre-operative mobilisation program using an educational training to improve mobility on mobility, pain, and post-operation length of stay of patients receiving a laparotomy [Auswirkung eines präoperativen Bewegungsschulungsprogrammes auf Mobilität, Schmerzen und postoperativer Verweildauer bei Patienten mit Laparatomie]

ISRCTN	ISRCTN32898285
DOI	https://doi.org/10.1186/ISRCTN32898285
Protocol serial number	Grant no 32.5.1331.0041.0
Sponsor	Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany)
Funders	Robert-Bosch Foundation (Germany) (ref: 32.5.1331.0041.0), Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany), University Hospital Ulm (Germany), Institute of Sport Science and Sport - University Bonn (Germany)

Submission date: 17/07/2009
Registration date: 29/07/2009
Last edited: 30/09/2014

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eva-Maria Panfil
Scientific

St. Gallen University of Applied Sciences
Rosenbergstr. 22
St. Gallen
CH-9001
Switzerland

Phone	+41 (0)71 226 15 25
Email	evamaria.panfil@fhsg.ch

Study information

Primary study design	Interventional
Study design	Prospective interventional single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Impact of a pre-operative mobilisation program using the Viv-Arte training model based on kinesthetic mobilisation on mobility, pain, and post-operation length of stay of patients receiving an elective medial laparotomy: a prospective, randomised controlled pilot trial [Auswirkungen eines präoperativen Bewegungsschulungsprogramms nach dem Viv-Arte Lernmodell auf Mobilität, Schmerzen und postoperative Verweildauer bei Patienten mit elektiver medianer Laparotomie: eine prospektive, randomisierte und kontrollierte Pilotstudie]
Study objectives	A pre-operative educational intervention to improve mobility is effective in regard to post-operative mobility, pain and hospital residence time after elective medial incision.
Ethics approval(s)	University Ulm (Germany) Ethics Committee, 23/03/2006, ref: 43/06 - UBB/se
Health condition(s) or problem(s) studied	Laparatomy with medial incision
Intervention	Before surgery: Both groups: general standard preparation by care staff, on the day before operation (shaving and laxative preparation, information on procedures with regard to operation). Control group: written information with information and motivation for active movement to prevent from thrombosis Experimental group: educational intervention, including exercise, written and oral information, duration about 30 minutes After surgery: Patients of both groups were (a) instructed to execute active movements according to the information sheet and (b) undergo mobilisation exercise without differences. (a) + (b) carried out two times a day, while the patient was in intensive care unit (a) + (b) carried out once a day, while the patient was in standard care unit. End of treatment: day of hospital leave, no follow-up after hospital leave. Secondary scientific contact details: Dr Michael Brach Institute of Sport Science University Muenster Horstmarer Landeweg 62b 48149 Muenster Germany Email: michael.brach@uni-muenster.de Jörg Haasenritter MSc Department of General Practice Preventive and Rehabilitative Medicine University Marburg Robert-Koch-Straße 5 (7a) 35032 Marburg Germany Email: haasenri@staff.uni-marburg.de
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Functional mobility: a new instrument was designed to observe the amount of assistance needed in 11 functional tasks (MOTPA, mobility test for patients in acute care): 1.1. Lying in the bed: moving to the top, moving sideward, transfer from back to lateral position, transfer from lateral lying position to sitting on the edge of the bed 1.2. Sitting on the edge of the bed: moving forward, keep sitting position, stand up 1.3. Standing position: turning 180°, going backwards three steps, short walk (6 m), walk (30 m), sitting down The mobility profile was recorded once pre-operative, post-surgical in intensive care unit: daily in the morning and in the afternoon and post-surgical in standard care unit: daily around noon. 2. Pain, assessed by Visual Analog Scale (VAS) (0 = no pain, 10 = unbearable pain), before, during, directly after, and 10 minutes after mobilisation and conduction of MOTPA 3. Post-surgical hospital residence time; date of medical operation and date of release were documented
Key secondary outcome measure(s)	1. Socio-demographic data (age, sex, education, profession), recorded pre-operatively 2. Mobility-related aids, recorded pre-operatively 3. Type of surgery after cystectomy (ileal conduit), recorded once post-surgical 4. Number of drainage and access canals, recorded at each mobilisation unit 5. Pain medication before (2 hours), during and after (30 minutes) mobilisation, recorded at each mobilisation unit 6. VAS pain intensity greater than 30 mm directly before mobilisation exercise results in cancellation of the mobilisation unit, recorded at each mobilisation unit 7. Post-operative complications (artificial ventilation for more than 6 hours after operation finish; reintubation; relaparatomy; other complications resulting in restriction of mobilisation, recorded once a day post-surgically). Presence of one of these complications results in exclusion of the patient from the trial. 8. Exercise, e.g. thrombosis, lung embolism; disorder of wound cure or suture, which are treated by a ventral bandage), recorded once a day post-surgically
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Cystectomy planned (ICD5-576) 2. Age 18 years and above, either sex 3. Ability to understand written and spoken German 4. Written informed consent
Key exclusion criteria	1. Impaired mobility (functional degree 2 or above, according to Gordon: dependent on personal assistance, supervision or guidance) 2. Chronic pain (duration above 3 months, with pharmacological treatment) 3. Dementia, medically documented 4. Anamnesis includes medial incision
Date of first enrolment	01/04/2006
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Germany
Switzerland

Study participating centre

St. Gallen University of Applied Sciences

St. Gallen
CH-9001
Switzerland

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	01/02/2009		Yes	No