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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201408000829202 |
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Date of registration:
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19/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The impact of an early mobilisation programme on the functional and health related quality of life outcomes of Intensive Care Unit patients in Zimbabw
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Scientific title:
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The impact of an early mobilisation programme on the functional and health related quality of life outcomes of Intensive Care Unit patients in Zimbabwe. |
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Date of first enrolment:
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07/05/2012 |
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Target sample size:
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200 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=829 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Non-randomised
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Phase:
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Not Applicable
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Cathrine
Tadyanemhandu |
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Address:
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6102 Mapfunde Road
263
Harare
Zimbabwe |
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Telephone:
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+263 779430792 |
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Email:
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cathytadya@gmail.com |
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Affiliation:
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Teaching Assistant at University of Zimbabwe |
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Name:
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Shamila
Manie |
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Address:
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Observatory 7925
7700
Capetown
South Africa |
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Telephone:
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27214066338 |
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Email:
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Shamila.Manie@uct.ac.za |
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Affiliation:
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Lecturer at University of Capetown |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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.
Age minimum:
18 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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critically ill patients in ICU
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critically ill patients in ICU
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Intervention(s)
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early mobilisation program
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standard physiotherapy
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Primary Outcome(s)
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functional status
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Secondary Outcome(s)
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duration period on mechanical ventilation
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Source(s) of Monetary Support
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University of Zimbabwe
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Ethics review
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Status: Approved
Approval date: 18/05/2012
Contact:
Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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