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
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