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 |
| Secondary identifying numbers | Grant no 32.5.1331.0041.0 |
- 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
Scientific
St. Gallen University of Applied Sciences
Rosenbergstr. 22
St. Gallen
CH-9001
Switzerland
| Phone | +41 (0)71 226 15 25 |
|---|---|
| evamaria.panfil@fhsg.ch |
Study information
| Study design | Prospective interventional single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2006 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
CH-9001
Switzerland
Sponsor information
Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany)
Research organisation
Research organisation
Fachhochschule Frankfurt am Main
University of Applied Sciences
Nibelungenplatz 1
Frankfurt am Main
60318
Germany
Funders
Funder type
Research organisation
Robert-Bosch Foundation (Germany) (ref: 32.5.1331.0041.0)
No information available
Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany)
No information available
University Hospital Ulm (Germany)
No information available
Institute of Sport Science and Sport - University Bonn (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 | 01/02/2009 | Yes | No |
