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.: PACTR201408000829202 Date of Approval: 19/05/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of an early mobilisation programme on the functional and health related quality of life outcomes of Intensive Care Unit patients in Zimbabw
Official scientific title The impact of an early mobilisation programme on the functional and health related quality of life outcomes of Intensive Care Unit patients in Zimbabwe.
Brief summary describing the background and objectives of the trial Traditionally the management of respiratory complications such as retained pulmonary secretions, atelectasis and the avoidance of re-intubation has been the major focus of physiotherapy treatment in ICU (Berney, Haines & Denehy 2012). However, the knowledge of the effects of complications (e.g. respiratory muscle weakness and atelectasis) on the long-term outcomes of the patients has resulted in changes in the standard clinical practice (Skinner et al., 2008). Early activity, including mobilizing critically ill patients, although not new, is an ICU intervention that is beginning to receive significant attention by physical therapists, nurses, and physicians as its positive impact on patients¿ outcomes after discharge is well documented (Morris & Herridge 2007). Furthermore, previous studies in the subject of early mobility had positive outcomes in other high income and medium income countries, but there is a need to investigate the practicality of this intervention in populations with different settings to determine its potential to meet the intervention¿s goals (Bowen et al., 2009)The primary aim of this study was to determine the feasibility of an early mobilisation intervention program and to report on the changes in patient clinical outcomes following the intervention comparing with a historical control group in one central hospital intensive care unit (ICU). The secondary aim was to ascertain the profile of ICU patients, as well as the scope of current services provided by physiotherapists in five central hospitals in Zimbabwe.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied critically ill patients in ICU
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 07/05/2012
Actual trial start date 06/06/2012
Anticipated date of last follow up 19/02/2013
Actual Last follow-up date 19/02/2013
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 172
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard physiotherapy once daily over a period of two months percussions, vibration, suctioning (chest physiotherapy), passive movements and active assisted movements in bed 137 Historical
Experimental Group early mobilisation program once daily over a period pf three months mobilising out of bed, sitting by the edge of the bed, come up to standing with or without assistance, marching on the spot, sitting in a chair, six minute walk test before discharge 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants who were admitted to ICU and High dependency unit (HDU) irrespective of ventilation method (non-invasive or invasive), aged 18 years old or older, medically stable and who consented or had their next of kin consent on their behalf to participate in the study were included. Mobilisation of participants was initiated based on a priori selected (Bailey et al., 2007) that included: ¿ Neurological criterion- the patient had to be awake which was assessed by response to verbal stimulation. ¿ Respiratory Criterion- a fraction of inspired oxygen (FiO2) of less than or equal to 0.6 and positive end expiratory pressure (PEEP) of less than or equal to 8cm of water. ¿ Circulatory criterion- the absence of orthostatic hypotension and catecholamine drips. All participants who had one of the following; ¿ Cognitive impairment before acute illness ¿ Inability to walk without assistance before acute illness ¿ Neuromuscular disease that could impair weaning (Myasthenia gravis, Guillian-Barre), acute stroke, head injury ¿ Hip fracture, unstable cervical spine and pathologic fracture ¿ Who were assessed by the medical staff as approaching imminent death ¿ Any participant the treating intensive care unit team advised on avoiding mobilisation for any other reason not aforementioned was also excluded. 18 Year(s) 80 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 18/05/2012 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Observatory 7925 Capetown 7700 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome functional status First day on recruitment Every day after recruitment and after physiotherapy Final day at discharge
Secondary Outcome duration period on mechanical ventilation at discharge from the unit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mpilo Hospital Box 2096 Bulawayo 263 Zimbabwe
Harare Hospital Box ST 14 Southerton Harare 263 Zimbabwe
United Bulawayo Hospitals Box 938 Bulawayo 263 Zimbabwe
Parirenyatwa Hospital CY198 Harare 263 Zimbabwe
Chitungwiza Hospital CZA 245 Harare 263 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Zimbabwe Box A178 Harare 263 Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Zimbabwe Box A178 Harare 263 Zimbabwe University
COLLABORATORS
Name Street address City Postal code Country
Shamila Manie Observatory 7925 Capetown 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cathrine Tadyanemhandu cathytadya@gmail.com +263 779430792 6102 Mapfunde Road
City Postal code Country Position/Affiliation
Harare 263 Zimbabwe Teaching Assistant at University of Zimbabwe
Role Name Email Phone Street address
Public Enquiries Shamila Manie Shamila.Manie@uct.ac.za 27214066338 Observatory 7925
City Postal code Country Position/Affiliation
Capetown 7700 South Africa Lecturer at University of Capetown
Role Name Email Phone Street address
Scientific Enquiries Cathrine Tadyanemhandu cathytadya@gmail.com +263 779430792 6102 Mapfunde Road
City Postal code Country Position/Affiliation
Harare 263 Zimbabwe Teaching Assistant at University of Zimbabwe
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information