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.: PACTR201501001016415 Date of Approval: 26/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assisted Autogenic Drainage (chest physiotherapy) in South African children with Cystic Fibrosis
Official scientific title The use of Assisted Autogenic Drainage in young South African children with Cystic Fibrosis
Brief summary describing the background and objectives of the trial Cystic fibrosis (CF) is a multisystem genetic disease which decreases the life-expectancy of the patient. Morbidity and mortality in children with CF is mainly determined by respiratory functioning. Airway clearance techniques, including autogenic drainage (AD) have shown small but positive effects on mucus clearance in children with CF. The problems with these studies are the small sample sizes, the cross-over study designs and the sometimes subjective outcome measures. There is currently no evidence to support any one airway clearance technique over another. No research has been done to determine the effectiveness of Assisted Autogenic Drainage (AAD) as an airway clearance technique for children with cystic fibrosis, but because of the equipoise in the chest physiotherapeutic treatment of patients with CF, AAD could be a good treatment alternative in these children. With this intention-to-treat trial, we hope to be able to find an additional treatment option for the home- based management of children with CF, which could influence the compliance and adherence to treatment. This study aims to determine whether AAD is more or as effective than standard physiotherapy as a home program in children with CF, determined by number of hospitalisations and respiratory exacerbations over one year, disease severity and progression, preference by parents and children, quality of life, weight-for-height (%) and neurodevelopmental level.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cystic fibrosis,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 13/01/2015
Actual trial start date 20/01/2015
Anticipated date of last follow up 29/03/2016
Actual Last follow-up date 26/07/2016
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 16
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
648/2013 Human Research Ethics Committee
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 Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Assisted Autogenic Drainage bidaily 10 to 30 min Assisted Autogenic Drainage (chest physiotherapy) 15
Control Group Standard Chest Physiotherapy bidaily 10 to 30 min Modified Postural Drainage, Positive Expiratory Pressure, Flutter, Vibrations, Percussions, Thoracic Compressions 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children between the age of one and eight years of age, suffering from CF, who are being followed up in Red Cross, will be considered for inclusion in the study. CF has to be diagnosed by sweat testing or genotype analysis. - Waiting for a lung/heart-transplantation - Severe scoliosis or kyphosis - Osteoporosis - Recent pneumothorax - Thoracic or abdominal surgery in the preceding six months - Emphysema - Active sarcoidosis - Prematurely born less than 30 weeks of gestation - On TB medication - Untreated asthma - Not on a treatment regime 2 months prior to enrolment - non-compliance prior to enrolment - mother language different from English, Afrikaans or Xhosa 1 Year(s) 8 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 07/11/2013 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Old Main Building, Grootte Schuur Hospital Observatory, Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of hospitalisations in one year After one year of intervention
Primary Outcome Number of exacerbations in one year, determined by antibiotic prescription and physician diagnosis After one year of intervention
Secondary Outcome Health Related Quality of Life measured by the EQ-5D-Y Measured at start of the study And after one year of intervention
Secondary Outcome Disease severity measured by the Cystic Fibrosis Clinical Score At start of the study And after one year of intervention
Secondary Outcome Patient's and/or parent's preference At the first CF-clinic follow up And after one year of intervention
Secondary Outcome Neurodevelopmental level, measured by the Peabody Developmental Motor Scale 2 and the movement ABC 2 At the start of the study And after one year of intervention
Secondary Outcome Mortality rate At the end of the study
Secondary Outcome Annual X-ray scores Once a year, taken around the time of the child's birthday
Secondary Outcome Lung function tests in children older than 5 years of age Quarterly tested
Secondary Outcome Weight-for-height (%) At start of the study And after one year of intervention
Secondary Outcome Weight-for-height (%) At start of the study And after one year of intervention
Secondary Outcome Lung function tests in children older than 5 years of age Quarterly tested
Secondary Outcome Annual X-ray scores Once a year, taken around the time of the child's birthday
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch, Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch, Cape Town 7700 South Africa
Institute of Child Health Award School of Child and Adolescent Health Rondebosch, Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Cape Town South Africa University
COLLABORATORS
Name Street address City Postal code Country
Lieselotte Corten Antwerpsesteenweg 474 Westmalle 2390 Belgium
Brenda Morrow Klipfontein Road Rondebosch, Cape Town 7700 South Africa
Jennifer Jelsma Division of Physiotherapy, University of Cape Town, Old Main Building, Grootte Schuur Hospital Observatory, Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brenda Morrow brenda.morrow@uct.ac.za +27 21 658 5074 Red Cross War Memorial Hospital, Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch, Cape Town 7700 South Africa Associated professor
Role Name Email Phone Street address
Public Enquiries Lieselotte Corten crtlie001@myuct.ac.za +27 71 588 37 29 Antwerpsesteenweg 474
City Postal code Country Position/Affiliation
Westmalle 2390 Belgium PhD-student at the University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Brenda Morrow brenda.morrow@uct.ac.za +27 21 658 5074 Red Cross War Memorial Hospital, Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch, Cape Town 7700 South Africa Associated professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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