Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000920695
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
28/08/2014
Date last updated
28/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an exercise program for children with chronic pulmonary disease: A pilot study
Scientific title
A randomised clinical trial of a group exercise program for improving cardiovascular fitness, fundamental movement skills, global self esteem and quality of life in school aged children with chronic pulmonary disease.
Secondary ID [1] 285153 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pulmonary Disease 292741 0
Non CF Bronchiectasis 292742 0
Asthma 292743 0
Cystic Fibrosis 292744 0
Condition category
Condition code
Respiratory 293035 293035 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 293036 293036 0 0
Cystic fibrosis
Respiratory 293144 293144 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a randomized trial to determine the effects of a specialized exercise program on physical and psychosocial health in children and adolescents with chronic respiratory disease. We wish to explore the hypothesis that our exercise program will enhance, cardiovascular fitness, fundamental movement skills (FMS), self-esteem and quality of life in those children.

Participants will complete the Motor Active exercise program offered by the University of Queensland, School of Human Movement Studies. Motor Active is an exercise program designed for children aged 4-12 years who have difficulty moving and playing in a controlled and coordinated manner. The program offers weekly small group sessions with an assigned instructor with expert knowledge of Exercise Physiology, and Health and Physical Education. Each session includes specialized activities individually tailored for each child and group interaction activities (warm-up, movement to music, cool-down and relaxation). The individual activities incorporate fundamental motor skills important for child development, including balance, strength, flexibility, agility, kicking, catching, batting, passing, coordination, locomotion, body awareness and fine motor activities.

The exercise program will run for 7 weeks. Children complete 1 session per week. Each session is 60 minutes in duration and divided in separate parts targeting cardiovascular fitness, fundamental motor skill development and social interaction:

* 3 group games (Warm up/middle game/warm down)
* Participation at different developmentally appropriate stations
targeting cardiovascular fitness and motor skill development.

Children will work in small groups of 2- 3 at each station with one instructor, who has expert knowledge of Exercise Physiology, and Health and Physical Education.

Measurements will be taken during the 2 weeks prior and 2 weeks after the program. The appointment for the measurements will be arranged individually. A measurement session will take 60 minutes and be conducted at The School of Human movement Studies, The university of Queensland, St Lucia.
Intervention code [1] 290001 0
Lifestyle
Intervention code [2] 290002 0
Treatment: Other
Comparator / control treatment
There will be a waiting control group. This group will commence the testing during the same time as the intervention group; will receive basic exercise information weekly during the time of intervention for the intervention group and will participate in the motor active program for 7 weeks after the post-testing. Information will contain exercise guidelines and material about exercise and chronic pulmonary conditions and will be sent out per email once a week.
Control group
Active

Outcomes
Primary outcome [1] 292903 0
Cardiovascular Fitness will be assessed by the PWC 170-bicycle test. This is an exercise test measuring the aerobic fitness by estimating VO2. Participants will be asked to ride an exercise bike in the lab for a total 15 minutes. Intensity will be increased gradually.
The first 3 minutes is an easy warm-up stage. During the next 9 minutes, the participant will complete three 3 minute stages in which the resistance on the pedals will be increased slightly, much like riding up a low grade hill. After the 9 minutes are over, there will be an easy 3-minute cool down stage. During the test, heart rate will be measured by a heart rate monitor. Pre and post results will be compared to each other.
Timepoint [1] 292903 0
Baseline
Immediately after Intervention (8 weeks)
Primary outcome [2] 292926 0
Fundamental Movement Skills will be assessed by
The Test of Gross Motor Development 2 (TGMD 2). This is a skill battery assessing the motor skills for children from 3-10 years. It includes 12 items, which are split up into 2 subscales called locomotor (run, gallop, hop, leap, horizontal jump and slide) and object control (Striking a stationary ball, stationary dribble, catch, kick, throw, and roll). Tasks are for all age classes the same. Children perform 3 trials of each activity. The presence or absence of skill criterions will be assessed. By presence of the criteria a 1 is logged by absence a 0 recorded. The scores are added up per subscale to derive a raw score. Maximal raw score for each subscale is 48. Pre and post scores will be compared to each other.
Timepoint [2] 292926 0
Baseline
Immediately after Intervention (8 weeks)
Secondary outcome [1] 309899 0
Global Self-esteem and self-perception will be assessed by the Harter’s Self- Perception Profile for children. This Questionnaire includes 36 Questions. The instrument adopts a multi-dimensional profile approach to assessing global self-worth by addressing elements of competence or adequacy in different life domains, including scholiastic competence, social competence, athletic competence, physical appearance, behavioural conduct and global self worth. The question format is specifically developed for this assessment tool to offset the tendency to give socially desirable responses. In each question 2 opposing types of child are described and the participant has to decide which kind of child he or she is most likely. After that the participant has to decide if this is really true or just true for him or her. The test maximal takes 20 minutes. Pre and post scores will be compared to each other.
Timepoint [1] 309899 0
Baseline
Immediately after Intervention (8 weeks)
Secondary outcome [2] 309900 0
Quality of Life will be assessed by the PedsQL. It consists of 2 parts: 23 questions are for the parents about their child and 23 are for the child. The domains covered by the questions are physical functioning, emotional functioning, social functioning and school functioning. Questions are asked for the time period of the past one month and are in a Likert Scale: 0 (never a problem) to 4 (almost always a problem) The test maximal takes 10 minutes. Pre and post scores will be compared to each other.
Timepoint [2] 309900 0
Baseline
Immediately after Intervention (8 weeks)

Eligibility
Key inclusion criteria
Children diagnosed with a chronic pulmonary disease: non CF Bronchiectasis, Cystic Fibrosis, Asthma; children between 8-12 years, able to follow directions and to complete the exercise program
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable medical condition; unstable emotional or behavioural status; unable to complete the exercise program; recent musculosceletal injuries e.g.: sprains, fracture, muscle strains

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2842 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 8531 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 289764 0
University
Name [1] 289764 0
The School of Human Movement Studies, The University of Queensland
Country [1] 289764 0
Australia
Primary sponsor type
Individual
Name
Barbara Joschtel
Address
C/- School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 288453 0
University
Name [1] 288453 0
The School of Human Movement Studies, The University of Queensland
Address [1] 288453 0
University of Queensland
St Lucia QLD 4072
Country [1] 288453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291495 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 291495 0
Level 3, RCH Foundation Building
Royal Children's Hospital
Herston Road
Herston QLD 4029
Australia
Ethics committee country [1] 291495 0
Australia
Date submitted for ethics approval [1] 291495 0
14/07/2014
Approval date [1] 291495 0
07/08/2014
Ethics approval number [1] 291495 0
HREC/14/QRCH/136

Summary
Brief summary
Over the past 30 years, the prevalence of chronic health conditions in children and adolescents has increased dramatically. For example, the Australian National Health Survey (2004-05) reports that 12% of children between 0-15 years have asthma as a long-term health condition. Adherence to complex therapy regimes is necessary for disease management and increased quality of life. Yet, available evidence suggests that 50% or less of children with chronic health conditions are adherent to therapy. Regular exercise is considered beneficial for children with chronic health conditions; however, the impact of exercise on psychosocial health and adherence to therapy is not well understood.

Furthermore, extended investigations of the literature has identified a gap in research about the benefits of exercise for children with chronic pulmonary disease other than asthma and cystic fibrosis. To date, no randomised controlled studies evaluating the effects of exercise on children with non cf bronchiectasis, broncho-pulmonary dysplasia or chronic suppurative lung disease have been conducted. The proposed study will advertise this void in the research literature by evaluating the impact of a 7 week exercise program on cardiovascular fitness, fundamental movement skills, self-esteem and quality of life.
The goal of the study is to test the effects of a 7 week exercise program on cardiovascular fitness, fundamental movement skills, self-esteem and quality of life in children and adolescents with chronic pulmonary diseases like cystic fibrosis, non cf-bronchiectasis and chronic supurative lung disease (CSLD). We hypothesise that the exercise program will enhance cardiovascular fitness, fundamental movement skills (FMS), self-esteem and quality of life in those children.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 50634 0
Miss Barbara Joschtel
Address 50634 0
C/- School of Human Movement Studies
University of Queensland,
ST LUCIA QLD 4072
Country 50634 0
Australia
Phone 50634 0
+61 (7) 3365 6117
Fax 50634 0
Email 50634 0
barbara.joschtel@uqconnect.edu.au
Contact person for public queries
Name 50635 0
Miss Barbara Joschtel
Address 50635 0
C/- School of Human Movement Studies
University of Queensland,
ST LUCIA QLD 4072
Country 50635 0
Australia
Phone 50635 0
+61 (7) 3365 6117
Fax 50635 0
Email 50635 0
barbara.joschtel@uqconnect.edu.au
Contact person for scientific queries
Name 50636 0
Miss Barbara Joschtel
Address 50636 0
C/- School of Human Movement Studies
University of Queensland,
ST LUCIA QLD 4072
Country 50636 0
Australia
Phone 50636 0
+61 (7) 3365 6117
Fax 50636 0
Email 50636 0
barbara.joschtel@uqconnect.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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