Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201809874713904 Date of Approval: 13/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of a single pre-operative physiotherapy session on physical function in elderly patients following abdominal surgery.
Official scientific title The effect of a single pre-operative physiotherapy session on physical function in elderly patients following abdominal surgery.
Brief summary describing the background and objectives of the trial Background: From an elderly patient’s perspective, physical function is a major indicator of surgical success. Complications such as post-operative pulmonary complications are common among the elderly. These complications lead to a longer hospital stay and may cause a greater loss of physical function. The decline of physical function then leads to a reduction in basic activities of daily living and quality of life. Recent literature shows that pre-surgical exercise and education may decrease length of hospital stay and maintain physical function. Aim: The aim of this study is to determine the effect of a single pre-operative physiotherapy session on physical function in elderly patients following abdominal surgery. The objectives of this study are to determine the following in elderly patients that will undergo abdominal surgery: - To describe the demographic profile; the pre-operative physical function status as determined by the Functional Comorbidity Index (FCI), the DeMorton Mobility Index (DEMMI) and the Six Minute Walk test (6MWT); pre-operative ADL status as assessed with the Lawton-Brody Instrumental Activities of Daily Living Scale (IADL). - To establish the effect of a single pre-operative physiotherapy session on clinical recovery as measured by the length of hospital and ICU stay, length of mechanical ventilation (MV), development of PPC and time of first mobilisation out of bed. - To determine the effect of a single pre-operative physiotherapy session on physical function and activities of daily living as measured on discharge and two weeks post-operatively. - To describe the relationship between the development of PPC and physical function. - To assess the adherence to a home based pre-operative physiotherapy exercise program.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 12
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
M180561 Human Research Ethics Committee Medical - University of the Witwatersrand
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Preoperative physiotherapy supervised education group One pre-operative session +/- 45 minutes Participants will receive an education pamphlet containing advise to follow post operatively e.g. how to cough with surgical wound support; how to take deep breaths to limit postoperative pulmonary complications; how to perform bed mobility and transfers out of bed to limit pain and discomfort; walking programme before surgery while at home to improve physical activity level. In addition the study participants will be taught strengthening exercises to improve their physical function level prior to surgery. 50
Control Group Education pamphlet One session +/- 20 minutes The control participants will receive an education pamphlet on advise that they should follow after surgery. This advise will include how to cough with wound support; how to take deep breaths to lessen the risk for postoperative pulmonary complications; how to perform bed mobilities and transfer out of bed to lessen any pain and physical discomfort. They will also be encouraged to follow a walking programme before surgery to improve their physical function prior to surgery. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 years and older (as per the United Nations agreed minimum age in reference to the elderly (WHO, 2016)). Walking with or without a mobility aid Scheduled for elective abdominal surgery (with abdominal surgery being defined as any incision below the diaphragm and above the inguinal ligament). At least one week delay before surgery Proficient in English Individuals with a known documented diagnosis of dementia or Alzheimer’s disease Diagnosed with an acute respiratory infection within two weeks of potential study participation Cardiovascular instability (such as unstable angina and NYHA class 4 heart failure) Use of immunosuppressive medication for 30 days before surgery Surgery with associated chest wall manipulation Aged: 65+ Year(s) 60 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2018 Human Research Ethics Committee Medical University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrance Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/07/2019 Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
29 Princes of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Demographic profile of study participants Baseline before hospital admission
Primary Outcome Physical function status of study participants as measured with the DeMorton Mobility Index and Lawton-Brody Instrumental Activities of Daily Living Scale. Baseline before hospital admission, Day of hospital discharge, Two weeks after hospital discharge
Primary Outcome Physical function capacity of study participants as measured with the six minute walk test. Baseline before hospital admission, Day of hospital discharge, Two weeks after hospital discharge
Secondary Outcome Clinical outcomes e.g. length of hospital stay (LOS), length of ICU stay, length of mechanical ventilation, development of postoperative pulmonary complications and the first time mobilised out of bed after surgery. Day of hospital discharge
Secondary Outcome Physical function according to comorbidities identified in study participants with the Functional Comorbidity Index. Baseline before hospital admission.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Peglerae Life Hospital 173 Beyers Naude Drive Rustenburg 0300 South Africa
MediClinic Midstream Midstream Dr Pretoria 692 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation of South Africa Pretoria Pretoria South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rozelle Labuschagne 255A Beyers Naude Drive Rustenburg 0305 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Rozelle Labuschagne 255A Beyers Naude Drive Rustenburg 0305 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rozelle Labuschagne rozelle.labuschagne@gmail.com +27145928322 255A Beyers Naude Drive
City Postal code Country Position/Affiliation
Rustenburg 0305 South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Ronel Roos ronel.roos@wits.ac.za +27117173723 7 York Road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer at the University of the Witwatersrand
Role Name Email Phone Street address
Public Enquiries Rozelle Labuschagne rozelle.labuschagne@gmail.com +27145928322 255A Beyers Naude Drive
City Postal code Country Position/Affiliation
Rustenburg 0305 South Africa Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information