Assisted Autogenic Drainage (chest physiotherapy) in South African children with Cystic Fibrosis

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201501001016415
• Date of registration: 26/01/2015
• Prospective Registration: No
• Primary sponsor: University of Cape Town
• Public title: Assisted Autogenic Drainage (chest physiotherapy) in South African children with Cystic Fibrosis
• Scientific title: The use of Assisted Autogenic Drainage in young South African children with Cystic Fibrosis
• Date of first enrolment: 13/01/2015
• Target sample size: 30
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1016
• Study type: Interventional
• Study design: 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
• Phase: Not Applicable

Countries of recruitment

South Africa

Contacts

• Name: Brenda Morrow
• Affiliation: Associated professor

• Name: Lieselotte Corten
• Affiliation: PhD-student at the University of Cape Town

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: - 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


Age minimum: 1 Year(s)
Age maximum: 8 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

cystic fibrosis

Fertility-female

Fertility-female
cystic fibrosis

Intervention(s)

Assisted Autogenic Drainage

Standard Chest Physiotherapy

Primary Outcome(s)

Number of hospitalisations in one year

Number of exacerbations in one year, determined by antibiotic prescription and physician diagnosis

Secondary Outcome(s)

Health Related Quality of Life measured by the EQ-5D-Y

Annual X-ray scores

Disease severity measured by the Cystic Fibrosis Clinical Score

Patient's and/or parent's preference

Mortality rate

Lung function tests in children older than 5 years of age

Neurodevelopmental level, measured by the Peabody Developmental Motor Scale 2 and the movement ABC 2

Weight-for-height (%)

Secondary ID(s)

648/2013

Source(s) of Monetary Support

Red Cross War Memorial Children's Hospital

Institute of Child Health Award

Ethics review

Status: Approved
Approval date: 07/11/2013
Contact:

Human Research Ethics Committee