Condition category
Surgery
Date applied
11/02/2008
Date assigned
11/04/2008
Last edited
26/04/2016
Prospective/Retrospective
Prospectively 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

Mr Sami Shimi

ORCID ID

Contact details

Dundee University and Medical School
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

sm110208/00

Study information

Scientific title

Effect of post-operative early mobilisation on pulmonary complications and hospital stay: a randomised trial

Acronym

Study hypothesis

Early mobilisation is used by many centres around the country, with physiotherapists hypothesising that movement will encourage deeper breaths due to increasing oxygen demand, improve muscle strength and patient confidence, reduce post-operative pulmonary complications (PPCs) and ultimately reduce length of stay. The aim of this study is to establish whether goal oriented early post-operative mobilisation would reduce post-operative pulmonary complications and reduce hospital length of stay in patients who have had elective abdominal surgery.

Ethics approval

Pending as of 12/02/2008: Ethics committee requires investigators to have registered with ISRCTN before considering their applications.

Study design

Parallel-group, single blinded, single centre, randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective upper and lower gastrointestinal (GI) surgery

Intervention

1. Control group: routine post-operative physiotherapy
2. Intervention group: routine post-operative physiotherapy and goal directed mobilisation

Patients will be encouraged to achieve progressive mobility goals as shown:
1. Up to sit out of bed
2. Mobilise 5 m assisted
3. Mobilise 20 m assisted
4. Mobilise 40 m independently

Each patient will be treated once each day, unless clinical need indicates further respiratory intervention. All patients will be reviewed for a minimum of 7 days post operatively, and until they have returned to their previous level of function.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Post-operative pulmonary complications: both the number of patients with these complication and the severity will be taken into account
2. Pulmonary function tests: the forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be collected pre-operatively and post-operatively on days 3, 5 and prior to hospital discharge

Secondary outcome measures

1. HDU stay
2. Hospital stay

Overall trial start date

01/05/2008

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Elective patients
2 Abdominal surgery
3. Booked in High Dependency Unit (HDU)
4. Ability to give written informed consent prior to study participation
5 Male or female patients over 18 years old
6. Ability to communicate with the study personnel and to comply with the study requirements
7. Ability to mobilise (freely or with walking aid)
8. American Society of Anaesthesiologists (ASA) grade 1 - 3 inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each group - upper and lower GI surgery)

Participant exclusion criteria

1. Inability to communicate with the study personnel and to comply with the study requirements (mobility)
2. Unable to give consent
3. Under 18 years of age
4. Patients admitted to Intensive Care Unit (ICU) prior to HDU
5. Patients with impaired mobility (bed bound or wheel chair bound)
6. ASA grade 4 or above

Recruitment start date

01/05/2008

Recruitment end date

01/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dundee University and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

26/04/2016: No publications found, verifying study status with principal investigator