Condition category
Surgery
Date applied
17/07/2009
Date assigned
29/07/2009
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eva-Maria Panfil

ORCID ID

Contact details

St. Gallen University of Applied Sciences
Rosenbergstr. 22
St. Gallen
CH-9001
Switzerland
+41 (0)71 226 15 25
evamaria.panfil@fhsg.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Grant no 32.5.1331.0041.0

Study information

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]

Acronym

Study hypothesis

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

University Ulm (Germany) Ethics Committee, 23/03/2006, ref: 43/06 - UBB/se

Study design

Prospective interventional single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/04/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany)

Sponsor details

Fachhochschule Frankfurt am Main
University of Applied Sciences
Nibelungenplatz 1
Frankfurt am Main
60318
Germany

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Robert-Bosch Foundation (Germany) (ref: 32.5.1331.0041.0)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hessian Institute of Nursing Research (Hessisches Institut für Pflegeforschung) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital Ulm (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Sport Science and Sport - University Bonn (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19173175

Publication citations

  1. Results

    Haasenritter J, Eisenschink AM, Kirchner E, Bauder-Missbach H, Brach M, Veith J, Sander S, Panfil EM, [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 study]., Pflege, 2009, 22, 1, 19-28, doi: 10.1024/1012-5302.22.1.19.

Additional files

Editorial Notes