Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000326493
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
11/03/2016
Date last updated
27/06/2022
Date data sharing statement initially provided
27/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a performance-focused swimming training program improve health, fitness and functioning in people with cerebral palsy?
Scientific title
Performance-focused Swimming Training for People with Cerebral Palsy: Evaluation of Clinical Outcomes
Secondary ID [1] 287896 0
None
Universal Trial Number (UTN)
U1111-1176-5481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 296776 0
Condition category
Condition code
Neurological 297011 297011 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 297128 297128 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following a familiarisation phase and baseline testing, each participant will complete a 16-week period of performance-focused swimming training which will be delivered by a multi-professional team of qualified swim coaches, physiotherapists and exercise physiologists. The term “performance-focused” refers to the fact that the sole aim of all strategies employed in this intervention will be to permit and then improve competitive swimming performance. In general, the program will comprise a combination of low to high intensity aerobic, strength, neuromotor and flexibility training which will be individually tailored to optimise swimming performance. This will involve a combination of gym-based training and pool-based training sessions. Within the gym-based sessions, a combination of land-based aerobic training, resistance training and stretching exercises will be carried out. Balance, proprioception and motor control training will also be included in the program. Swimming training in this phase will aim to improve swimming technique, aerobic and anaerobic endurance, speed and in-water power, race starts and the ability to maintain maximal pace. The frequency and duration of training sessions will vary, but will aim to gradually increase over the course of the phase. Training will be carried out in a combination of group and one-on-one sessions, and participants will be paired with a non-disabled volunteer training buddy who will complete exercise sessions with them, providing motivational support and exercise assistance (e.g., equipment access, exercise positioning, and in-water support).

Participants will also receive advice from undergraduate dietetics students and postgraduate sports psychology students at the University of Queensland. This element of the intervention will be primarily educational, and will be included to support the participants in the transition into sports participation. The support from dietetics students will aim to enhance the participant’s understanding of healthy dietary behaviours, and sports psychology students will utilise techniques known to enhance motivational readiness such as goal setting and self-monitoring while training. In the final 2 weeks of the 16-week period participants will taper – that is, training volume will be reduced in a systematic, non-linear fashion with the aim of facilitating recovery and optimising peak performance at a competitive event. Participants who are able to complete 50 metres of continuous swimming will be entered into a local competition conducted by an accredited swimming club. If participants are unable safely to complete 50 metres – the minimum distance for an official competition – a competitive event will be tailored for them in which they will compete against other invited swimmers in a competition which conforms as closely with para swimming rules as possible.


Following the first performance-focused training period and time trial, there will be a 5-week ‘maintenance’ phase during which training will be withdrawn. This phase will act as a recovery period for participants, however testing will continue.

Following the maintenance phase, the participants will train for a further 16 weeks. This will once again be a performance-focused cycle of training which aims to increase independent swim distance and enhance swimming speed. The same principles of training used in training period 1 will be applied in training period 2: a combination of low to high intensity aerobic, strength, neuromotor and flexibility training which is designed to optimise swimming performance. Participants will continue to train in groups and one-on-one with their training buddies, and will continue to receive advice from undergraduate dietetics students and postgraduate sports psychology students at the University of Queensland. Once again, participants will complete a timed maximal swim over a distance suited to their ability in the final weeks of the 16-week training period.

Following completion of the MBD, the study will continue for a further a 4-year period. The participants will continue the same training program for 4 further seasons, aligned with the competitive swimming season in Queensland, Australia. Withdrawal phases will be incorporated within and between seasons to facilitate recovery. (UQ ethical approval #2018001472).
Intervention code [1] 293255 0
Treatment: Other
Intervention code [2] 293433 0
Lifestyle
Comparator / control treatment
The research design for this study will be a concurrent multiple baseline design (MBD) across 3 participants. The MBD is a type of n-of-one design, the defining feature of which is that a person is measured on an outcome variable repeatedly over time during multiple phases. These phases will be different in that they will be either baseline/maintenance phases during which the intervention is not present (A phases) or treatment phases during which the intervention is present (B phases). As this study aims to evaluate the effect of performance-focused swimming training, each of the ‘A’ phases will represent time during which there will be no training. ‘B’ phases will represent a period during which the participant engages in performance-focused swimming training. This study will comprise 5 phases: A1, B1, A2, B2 and A3.

The A1 phase is a baseline testing phase during which participants will be asked to continue with their usual lifestyle, including physical activity behaviour. The purpose of collecting baseline data is to establish a pattern of response in the outcome variable which is sufficiently consistent to allow prediction of the future response under the same conditions. In order to terminate a baseline phase it must be possible to assume that if measurements continued without any exposure to the intervention, outcome variable responses should be similarly consistent and within the previously observed measurement ranges. In this research design the participants act as their own control, and it can be inferred that responses in measures may be attributed to the introduction of the intervention alone.
Control group
Active

Outcomes
Primary outcome [1] 296604 0
Health: SF-36 score
Timepoint [1] 296604 0
Weeks 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Primary outcome [2] 296605 0
Fitness: V02 max test on arm crank ergometer
Timepoint [2] 296605 0
Weeks 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Primary outcome [3] 296606 0
Function: Gross Motor Function Measure 66 Item Set
Timepoint [3] 296606 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, then every 3 months during the 4-year extension of the trial.
Secondary outcome [1] 318902 0
Athletic Identity: The athletic identity measurement scale
Timepoint [1] 318902 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [2] 318903 0
Life Satisfaction: The satisfaction with life scale
Timepoint [2] 318903 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [3] 318904 0
Self Efficacy: Self Efficacy Questionnaire

Source: Motl, R. W., Dishman, R. K., Trost, S. G., Saunders, R. P., Dowda, M., Felton, G., Ward, D. S., Pate, R. R.. (2000). Factorial validity and invariance of questionnaires measuring social-cognitive determinants of physical activity among adolescent girls. Preventative Medicine. 31 (5), 584-594.
Timepoint [3] 318904 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [4] 318905 0
Attitude: Attitude Questionnaire

Source: Motl, R. W., Dishman, R. K., Trost, S. G., Saunders, R. P., Dowda, M., Felton, G., Ward, D. S., Pate, R. R.. (2000). Factorial validity and invariance of questionnaires measuring social-cognitive determinants of physical activity among adolescent girls. Preventative Medicine. 31 (5), 584-594.
Timepoint [4] 318905 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [5] 318906 0
Perceived Behavioral Control: Perceived Behavioral Control Questionnaire

Source: Motl, R. W., Dishman, R. K., Trost, S. G., Saunders, R. P., Dowda, M., Felton, G., Ward, D. S., Pate, R. R.. (2000). Factorial validity and invariance of questionnaires measuring social-cognitive determinants of physical activity among adolescent girls. Preventative Medicine. 31 (5), 584-594.
Timepoint [5] 318906 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [6] 318907 0
Function: the functional independence measure
Timepoint [6] 318907 0
1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [7] 318908 0
Resilience: resilience scale
Timepoint [7] 318908 0
Weeks: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [8] 318909 0
Fatigue: fatigue severity scale
Timepoint [8] 318909 0
Weeks: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [9] 318910 0
Strength: 3 repetition max test in the following exercises
1) Shoulder press
2) Leg press
3) Lat pull down
4) Seated leg extension
5) Bench press
6) Hamstring curl
7) Seated Row
Timepoint [9] 318910 0
Weeks: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [10] 318911 0
Body composition: Skinfold Thickness
Timepoint [10] 318911 0
Weeks: 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [11] 318912 0
Body composition: dexa scan
Timepoint [11] 318912 0
Weeks: 1, 15, 30, 45, 60
Secondary outcome [12] 318913 0
Isometric strength: developed for this study and measured using a load cell. Participants will be in a standardised position and will perform the following isometric actions:
1) Shoulder extension in supported sitting
2) Hip flexion in side lying
3) Hip extension in side lying
Timepoint [12] 318913 0
Weeks: 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [13] 318914 0
Active and passive range of movement will be measured using goniometers and digital inclinometers. Tests were developed for this study and will measure:
1) Shoulder flexion, extension, internal and external rotation.
2) Shoulder horizontal extension at 90 degrees of abduction
3) Elbow extension
4) Pronation and supination
5) Cervical and thoracic rotation
6) Hip extension
7) Knee extension
8) Plantarflexion and dorsiflexion
Timepoint [13] 318914 0
Weeks: 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [14] 318915 0
Reciprocal tapping tasks to assess speed and accuracy of movement - developed for this study
Timepoint [14] 318915 0
Weeks: 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [15] 318916 0
Postural stability: modified functional reach test and sitting assessment scale
Timepoint [15] 318916 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [16] 318918 0
Oxygen cost of arm cranking at self-selected speed, tested by measuring volume of oxygen consumption during walking/wheeling for 6 minutes at a self-selected, comfortable speed using gas analysis equipment.
Timepoint [16] 318918 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [17] 318919 0
Swimming performance: time trial (developed for this study)
Timepoint [17] 318919 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, then every 3 months during the 4-year extension of the trial.
Secondary outcome [18] 318920 0
Swimming skill acquisition: modified amateur swimming association level (developed for this study)
Timepoint [18] 318920 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [19] 331758 0
Swimming Skill Acquisition: Water Orientation Test-Alyn
Timepoint [19] 331758 0
Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [20] 331759 0
Body Composition: DXA scan
Timepoint [20] 331759 0
Weeks 1, 15, 30, 45, 60
Secondary outcome [21] 331760 0
Life History Description: Semi Structured Interview
Timepoint [21] 331760 0
Week 15, 30, 45, 60
Secondary outcome [22] 349221 0
The PedsQL Cerebral Palsy Module for Teenagers Questionnaires
Timepoint [22] 349221 0
Weeks: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59

Eligibility
Key inclusion criteria
a) Cerebral palsy, GMFCS III IV or V;
b) Aged greater than or equal to 15 years and less than 35 years;
c) Insufficiently active for health (i.e. not consistently meeting national physical activity guidelines);
d) have not participated in a performance focused swimming training program in the past five years;
e) high water confidence;
f) can be safely supervised in the water by a single qualified instructor and able to safely disengage for at least three seconds;
g) Medically fit to participate in a graduated swim for fitness program including:
i. Water Immersion: no medical contraindications to water immersion (i.e., ability to safely swallow thin fluids and a strong effective cough); and
ii. Seizure Disorder: no seizure disorder or, affected by a seizure disorder which did not increase in severity or frequency with exertion and for which there was a management plan could be executed by a single qualified instructor
h) Intellectually able to understand and engage in supervised exercise; and
i) Have sufficient time and/or family support to commit to the intervention.
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Recent serious musculoskeletal injury or illness;
b) Major surgery in the last six months or currently scheduled;
c) High Cardiovascular Risk;
d) Compromised skin integrity that is contagious, severe or ongoing;
e) Pain levels which affect ability to engage in exercise;
f) Significant intellectual impairment which affects ability to follow instructions; and
g) Significant dysphagia or oromotor dysfunction with an associated increase in the risk of aspiration.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
The research design for this study will be a concurrent multiple baseline design (MBD) across 3 participants. The MBD is a type of n-of-one design, the defining feature of which is that a person is measured on an outcome variable repeatedly over time during multiple phases. These phases will be different in that they will be either baseline/maintenance phases during which the intervention is not present (A phases) or treatment phases during which the intervention is present (B phases). As this study aims to evaluate the effect of performance-focused swimming training, each of the ‘A’ phases will represent time during which there will be no training. ‘B’ phases will represent a period during which the participant engages in performance-focused swimming training. This study will comprise 5 phases: A1, B1, A2, B2 and A3.

The A1 phase is a baseline testing phase during which participants will be asked to continue with their usual lifestyle, including physical activity behaviour. The purpose of collecting baseline data is to establish a pattern of response in the outcome variable which is sufficiently consistent to allow prediction of the future response under the same conditions. In order to terminate a baseline phase it must be possible to assume that if measurements continued without any exposure to the intervention, outcome variable responses should be similarly consistent and within the previously observed measurement ranges. In this research design the participants act as their own control, and it can be inferred that responses in measures may be attributed to the introduction of the intervention alone. The baseline for participant 1 will be 10 weeks in duration with 5 data collection points; the baseline for participant 2 will be 16 weeks in duration with 8 data collection points; and the baseline duration for participant 3 will be 22 weeks with 11 data collection points.

This will be followed by a 16-week performanced-focused swimming training program., during which there will be a further 8 data collection points for each participant.

This will be followed by a 5-week maintenance phase during which there will be no training. There will be a further 5 data collection points for each participant in this phase.

This will be followed by a 16-week performanced-focused swimming training program., during which there will be a further 8 data collection points for each participant.

The final phase will be a 5-week maintenance phase during which there will be no training. There will be a further 5 data collection points for each participant in this phase.

Following completion of the MBD, the study will continue for a further a 4-year period. The participants will continue their training for 4 further seasons, aligned with the competitive swimming season in Queensland, Australia. Withdrawal phases will be incorporated within and between seasons to facilitate recovery. Gross motor function, swimming performance and training load will be longitudinally monitored throughout the study on a monthly basis (UQ ethical approval #2018001472).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In consideration of the commitment required from participants, the population of interest, the length of the study and the volume of testing, it was deemed not feasible to conduct a sufficiently statistically powered randomised controlled trial at this time. Instead, given the above conditions, we aim to conduct intensive investigations in between 3 and 5 individuals using an n-of-1 research design. Randomised n-of-1 trials are ranked as Level 1 evidence for treatment decision purposes in individual patients (Tate et al., 2013), and permit intensive investigations of individual participants during baseline and at least one intervention phase. Outcomes will be repeatedly measured during all phases to determine the effects of the intervention.

Visual analysis of graphed data, following standard conventions, will be the primary method used to evaluate the differences between baseline, intervention and withdrawal phases. Features of graphed data will be examined within- and between-phases, evaluating the following:
1) Level
2) Trend
3) Variability
4) Immediacy of effect
5) Data overlap
6) Consistency of data patterns across similar phases

Tate, R. L., Perdices, M., Rosenkoetter, U., Wakim, D., Godbee, K., Togher., L., McDonald, S. (2013). Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: The 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsycholigical Rehabilitation, 23(5), 619-638.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
5/05/2017
Date of last participant enrolment
Anticipated
31/03/2017
Actual
1/06/2017
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292392 0
Charities/Societies/Foundations
Name [1] 292392 0
Australian Paralympic Committee
Country [1] 292392 0
Australia
Funding source category [2] 292393 0
Government body
Name [2] 292393 0
Swimming Australia
Country [2] 292393 0
Australia
Funding source category [3] 292394 0
Government body
Name [3] 292394 0
Queensland Academy of Sport
Country [3] 292394 0
Australia
Funding source category [4] 292410 0
University
Name [4] 292410 0
University of Queensland
Country [4] 292410 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country
Australia
Secondary sponsor category [1] 291076 0
Charities/Societies/Foundations
Name [1] 291076 0
International Paralympic Committee
Address [1] 291076 0
Agitos Foundation
Adenauerallee 212-214
53113 Bonn
Germany
Country [1] 291076 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293862 0
University of Queensland
Ethics committee address [1] 293862 0
Ethics committee country [1] 293862 0
Australia
Date submitted for ethics approval [1] 293862 0
13/04/2015
Approval date [1] 293862 0
15/07/2015
Ethics approval number [1] 293862 0
2015000831
Ethics committee name [2] 296954 0
Cerebral Palsy League
Ethics committee address [2] 296954 0
Ethics committee country [2] 296954 0
Australia
Date submitted for ethics approval [2] 296954 0
14/12/2016
Approval date [2] 296954 0
16/01/2017
Ethics approval number [2] 296954 0
CPL-2015-003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61546 0
Dr Sean Tweedy
Address 61546 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 61546 0
Australia
Phone 61546 0
+61 7 3365 6638
Fax 61546 0
+61 7 3365 6877
Email 61546 0
[email protected]
Contact person for public queries
Name 61547 0
Iain Dutia
Address 61547 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 61547 0
Australia
Phone 61547 0
+61 7 3365 4998
Fax 61547 0
Email 61547 0
[email protected]
Contact person for scientific queries
Name 61548 0
Sean Tweedy
Address 61548 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Country 61548 0
Australia
Phone 61548 0
+61 7 3365 6638
Fax 61548 0
Email 61548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.