Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000268448
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
29/02/2016
Date last updated
29/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an individualised performance-focused swimming training program improve health, fitness and function in individuals following megaprosthesis bone replacement surgery?
Scientific title
Does an individualised performance-focused swimming training program improve health, fitness and function in individuals following megaprosthesis bone replacement surgery?
Secondary ID [1] 288020 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Sarcoma 296891 0
Otherwise unmanageable bony conditions 296892 0
Condition category
Condition code
Cancer 297119 297119 0 0
Bone
Musculoskeletal 297120 297120 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297986 297986 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1. Baseline
Participants will complete a 15-week pre-participation period or baseline during which they continue with their current lifestyle, including physical activity levels, and report to The University of Queensland on a weekly basis for testing (further detail to follow).

Phase 2. Introductory training
Individuals who complete the pre-participation period will then participate in a 15-week low to moderate intensity health focused training program comprising four main training modalities:
1.) Land-based aerobic training,
2.) Resistance training,
3.) Neuromotor training
4.) Swimming.
Modalities will be interspersed throughout the intervention and progressed on an individual basis.

Training dose:
The frequency, intensity, duration and activities included in each session will steadily progress over 15 weeks in order to bring participants to the point where participants are:
1.) Meeting national physical activity guidelines for health (150 minutes of moderate intensity physical activity per week including two resistance training sessions)
2.) Remediating existing deficits in lower limb strength and range of motion.
3.) Able to swim competently and safely for fitness.

Training intensity will be monitored using heart rate monitors and Rating of Perceived Exertion (RPE), Prescribed target heart rate during training sessions will be between 40-70% of heart rate maximum.
The prescription of frequency and duration of training sessions will be individualised based on each participant's exercise tolerance and baseline physical activity levels. As stated above, the duration and intensity of training will slowly and safely be increased until each participant is able to meet the above criteria.

This phase may continue longer than 15 weeks if the participant is unable to meet these criteria within the time frame. One of the main purposes of this run-in period is to bring all participants to the same baseline physical activity level before progressing them to undertake sports performance-focused training.

Phase 3. Performance-focused Swimming Training
Once the above criteria are met, participants will progress on to a 15-week, swimming performance focused training program designed to enhance stroke technique, aerobic and anaerobic endurance, in-water power, race starts and swim speed.
The program will be comprised of moderate to high intensity:
1.) Land-based aerobic training,
2.) Resistance training,
3.) Neuromotor training
4.) Swimming training.
Modalities will be interspersed throughout the intervention and progressed on an individual basis - tailored to optimise each individuals swimming performance.

Training dose
During this phase of the project, participants will be training up to 4 sessions per week, the frequency, intensity and duration of each session will be prescribed based on the participant's individual exercise tolerance and fitness level. Training intensity will be monitored using heart rate monitors and Rating of Perceived Exertion (RPE) as per phase one of the study, The intensity of training in this phase will range from easy to challenging, and will aim to elicit an RPE score of between three and ten, depending on the aim of the session. Prescribed target heart rate during training sessions will be between 40-100% of heart rate maximum.
the duration and intensity of training will continue to be slowly and safely increased until the participant is consistently exceeding moderate levels of physical activity i.e. completing more than 150 minutes of moderate intensity physical activity per week including two strength sessions.

Phase 4. Maintenance/off-season
This phase will mirror phase one, baseline. Participants will complete a 15-week off season or maintenance period during which they continue with their current lifestyle, including physical activity levels, and report to The University of Queensland on a weekly basis for testing.

Exercise prescription
Training programs included in both phase two and phase three of this study will be designed specifically for each individual, taking into account the training principles of specificity, progressive overload, reversibility, variety, initial values and diminishing returns. Exercise prescription will also employ the ACSM’s FITT-VP principles: Frequency, intensity, type, time, volume, pattern and progression. By employing these principles we hope to maintain participant safety, decrease injury risk and optimise participant adherence and exercise benefit.
Training will utilise a combination of land and pool-based training sessions. Within the land-based sessions, a combination of resistance, flexibility, balance, proprioception and motor control training will be used.

Training monitoring
Throughout the intervention (during both the introductory program and the performance-focused program) adherence to the program will be logged using a training diary which is completed by the participant. This will include: frequency, intensity, duration, type of training, level of enjoyment, pain and fatigue. Semi-structured interviews will also be conducted on an 8-weekly basis to ascertain participant's perception of the program.

Training delivery
All training programs will be designed and administered by a combination of swimming coaches, exercise scientists and physiotherapists. As recruitment into this study will be progressive, mode of training delivery will vary. Participants may be supervised and trained one-to-one face-to-face or in small groups of no more than three individuals to one practitioner.
Intervention code [1] 293349 0
Rehabilitation
Intervention code [2] 294049 0
Lifestyle
Comparator / control treatment
This study will adopt an N-of-1 A-B-C-A research design, and will include a 15-week baseline testing period consisting of five data collection points, therefore subjects are able to act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 296740 0
Strength
- Upper limb and lower limb isometric strength
Data obtained using an S-type load cell mounted on a rigid, custom build rig, designed specifically for research in impairment classification in Paralympic sport.
Participants will be placed in a standardised position and will perform the following isometric actions, which have been developed specifically for this study.
1) Shoulder extension in supported sitting
2) Hip flexion in side lying
3) Hip extension in side lying
Timepoint [1] 296740 0
WEEK: 1, 4, 5, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Primary outcome [2] 297491 0
Physical Function
- Musculoskeletal Tumour Society Score (MSTS)
Timepoint [2] 297491 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Primary outcome [3] 297492 0
Range of Motion
- Inclinometer
- eHAB software

Joint ranges assessed:
Upper Limb
1.) Active shoulder flexion
2.) Active shoulder extension
3.) Active shoulder horizontal abduction
4.) Active shoulder internal rotation
5.) Active shoulder external rotation
6.) Active wrist pronation/supination
7.) Active cervical rotation

Lower Limb
1.) Active hip and knee extension (composite measure)
2.) Active plantar flexion
3.) Active and passive knee flexion
4.) Active and passive hip flexion
Timepoint [3] 297492 0
WEEK: 1, 4, 5, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [1] 319226 0
Depression, Stress and Anxiety
-Depression, Anxiety & Stress Scale (DASS))
Timepoint [1] 319226 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [2] 321152 0
Physical activity and sports participation
- Active Australia Questionnaire
Timepoint [2] 321152 0
WEEK: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [3] 321153 0
Self-efficacy
- Dishman Self Efficacy Questionnaire
Timepoint [3] 321153 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [4] 321154 0
Satisfaction With Life
- Satisfaction With Life Scale
Timepoint [4] 321154 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [5] 321155 0
Athletic Identity
- Athletic Identity Measurement Scale (AIMS)
Timepoint [5] 321155 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [6] 321156 0
Fatigue
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACiT-F v4) Questionnaire
Timepoint [6] 321156 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [7] 321157 0
Quality of Life
- The Short Form 36 Health Survey (SF-36)
Timepoint [7] 321157 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [8] 321195 0
Coordination
- Unilateral reciprocal tapping task
- Bilateral simultaneous rapid alternating movement
Timepoint [8] 321195 0
WEEK: 1, 4, 5, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [9] 321196 0
Functional Capacity
- 6MWT
Timepoint [9] 321196 0
WEEK: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [10] 321197 0
Aerobic capacity
- VO2max (ml/kg/min) on arm crank ergometer using metabolic cart -gas analysis and Metamax2 and MetaSoft software
Timepoint [10] 321197 0
WEEK: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [11] 321199 0
3D gait analysis
- Gait velocity (preferred) (m.s-1)
- Cadence (steps/min-1)
- Step width (m)
- Step length (m)
- Gait cycle time (s)
- Ground reaction forces (GRF) (N.kg-1)
- Joint powers (W/kg.m)
- Internal Joint moments (torque) (Nm/kg.m)
- Muscle co-contraction
- Mean muscle activation time
Timepoint [11] 321199 0
WEEK: 14, 29, 44, 59
Secondary outcome [12] 321200 0
Muscle volume/cross sectional area
- Computed tomography (CT) scans
- Magnetic resonance imaging (MRI) scans
Timepoint [12] 321200 0
WEEK: 15, 30, 45, 60
Secondary outcome [13] 321245 0
Strength
Upper limb and lower limb 3-5 repetition maximum testing:
Exercises included:
1) Shoulder press
2) Leg press
3) Lat pull down
4) Seated leg extension
5) Bench press
6) Hamstring curl
7) Seated Row
Timepoint [13] 321245 0
WEEK: 1, 4, 5, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58
Secondary outcome [14] 321246 0
Physical function (primary outcome)
- Toronto Extremity Salvage Score (TESS)
Timepoint [14] 321246 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [15] 321247 0
Physical function (primary outcome)
- Functional Mobility Assessment (FMA)
Timepoint [15] 321247 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [16] 321248 0
Physical Function (primary outcome)
- High Level Mobility Assessment Tool (HiMAT)
Timepoint [16] 321248 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [17] 321249 0
Physical Activity Questionnaire
- Baecke Physical Activity Questionnaire
Timepoint [17] 321249 0
WEEK: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Secondary outcome [18] 321250 0
Semi-structured questionnaires/interviews
Timepoint [18] 321250 0
WEEKS: 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60
Secondary outcome [19] 321251 0
Quality of Life (primary outcome)
- Questionnaire for Children and Adolescents after Bone Tumour Surgery (Bt-DUX)
Timepoint [19] 321251 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59
Secondary outcome [20] 321252 0
Quality of Life
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core - 30 (EORTC QLQ-C30)
Timepoint [20] 321252 0
WEEK: 2, 5, 8, 11, 14, 17, 20, 23, 26, 29, 32, 35, 38, 41, 44, 47, 50, 53, 56, 59

Eligibility
Key inclusion criteria
Participants with megaprosthesis:
a.) Patients will have had insertion of a lower limb (proximal tibia, distal femur, proximal femur, total femur) megaprosthesis for management of bony disease.
b.) Age: 15-30 years
c.) greater than or equal to 1 year post surgery
d.) Insufficiently active for health at time of recruitment (do not participate in at least 150 minutes of moderate intensity physical activity including 2 resistance training sessions per week)
e.) Medically fit to undertake at least moderate intensity physical activity, as determined by an orthopaedic oncologist
f.) Completed adjuvant treatment at time of recruitment
g.) Free of local or metastatic disease at time of recruitment
h.) Interested in participating in physical activity
i.) Willing to travel to The University of Queensland up to four times per week for the duration of the study
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a.) Intellectual disability/impairment or illness or injury which impacts upon the ability of the participant to follow the instructions required to safely complete the testing and training protocol as required.
Example: Recent serious musculoskeletal injury, illness or operation; cardiovascular risk, uncontrolled seizure disorder.

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
This study will adopt an N-of-1 A-B-C-A Single Subject Research Design (SSRD) with data collection at 20 time points:
Phase 1. (15 weeks) - 5 baseline, taken prior to the intervention
Phase 2 (15 weeks) - 5 peri/post moderate intensity health focused training program
Phase 3. (15 weeks) - 5 peri/post a swimming focused training program
Phase 4. (15 weeks) - 5 peri/post a maintenance phase/off-season
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In consideration of the the population of interest, the time commitment required from participants, the length of the study and the volume of testing, it is not deemed feasible to conduct a sufficiently statistically powered randomised controlled trial in this study. The research group proposes to conduct intensive investigations in up to 10 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
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2016
Actual
Date of last participant enrolment
Anticipated
30/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4747 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 4748 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 4749 0
The Wesley Hospital - Auchenflower
Recruitment hospital [4] 5354 0
Mater Private Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 292473 0
University
Name [1] 292473 0
University of Queensland, School of Human Movement RHD Student Research Fund
Country [1] 292473 0
Australia
Funding source category [2] 292986 0
University
Name [2] 292986 0
The University of Queensland Centre for Advance Imaging (UQ CAI)
Country [2] 292986 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Human Movement and Nutrition Sciences, Building 26B, Blair Drive
St Lucia
Queensland 4072
Country
Australia
Secondary sponsor category [1] 291758 0
None
Name [1] 291758 0
Address [1] 291758 0
Country [1] 291758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293939 0
Metro South HREC
Ethics committee address [1] 293939 0
PAH Centres for Health Research
Level 7, Translation Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Ethics committee country [1] 293939 0
Australia
Date submitted for ethics approval [1] 293939 0
14/01/2016
Approval date [1] 293939 0
09/02/2016
Ethics approval number [1] 293939 0
HREC/16/QPAH/48

Summary
Brief summary
The aim of this project is to evaluate the effectiveness of an individualised, moderate intensity health focused training program, and a swimming performance focused training program at improving health, fitness and function in people with a megaprosthesis. Who is it for? You may be eligible to join this study if you are aged between 15 to 30 years, have had a lower limb megaprosthesis inserted at least 1 year ago, and are insufficiently active for health but are interested in participating in competitive sport. Study details: All participants in this study will partake in a four phase, 14 month (60 week) intervention, consisting of 15 weeks baseline, 30 weeks exercise training and 15 weeks of maintenance/off season monitoring. The study will be administered by a combination of swimming coaches, exercise scientists and physiotherapists. Training will include land and pool based sessions. Exercise choice will promote strength, aerobic capacity, neuromotor function, flexibility and swim performance. Frequency, intensity, duration and activities included in each training session will be individually prescribed and progressed based on each participants individual exercise tolerance. Regular testing will be conducted throughout the study to evaluate health, physical fitness and function.. We hope that information gained from this research will help to inform discussion as to whether individuals that have had a lower limb megaprosthesis should be eligible for participation in Paralympic sport within the current classification system or whether changes are warranted.
Trial website
Trial related presentations / publications
AUTHORS:
Wilson, P.J., Steadman, P., Beckman, E. M., Carty, C. P., & Tweedy, S.M.

POSTER TITLE: Return to sport and high level function post insertion of megaprosthesis in adolescent and young adults – Research requirements and methodological challenges.
Lower Limb Megaprosthesis and Paralympic Sport

CONFERENCE
International Society of Limb Salvage and Musculoskeletal Tumour Society General Meeting.

CONFERENCE DATE
October 6-10th 2015




Public notes

Contacts
Principal investigator
Name 61854 0
Dr Sean Tweedy
Address 61854 0
The School of Human Movement and Nutrition Sciences
Human Movement Studies Building 26(B)
Blair Drive
The University of Queensland
St Lucia
QLD 4072
Country 61854 0
Australia
Phone 61854 0
+61 7 33656638
Fax 61854 0
+61 7 3365 6877
Email 61854 0
s.tweedy@uq.edu.au
Contact person for public queries
Name 61855 0
Miss Paula Wilson
Address 61855 0
The School of Human Movement and Nutrition Sciences
Human Movement Studies Building 26(B)
Blair Drive
The University of Queensland
St Lucia
QLD 4072
Country 61855 0
Australia
Phone 61855 0
+61 7 33654998
Fax 61855 0
+61 7 3365 6877
Email 61855 0
paula.wilson@uqconnect.edu.au
Contact person for scientific queries
Name 61856 0
Dr Sean Tweedy
Address 61856 0
The School of Human Movement and Nutrition Sciences
Human Movement Studies Building 26(B)
Blair Drive
The University of Queensland
St Lucia
QLD 4072
Country 61856 0
Australia
Phone 61856 0
+61 7 33656638
Fax 61856 0
+61 7 3365 6877
Email 61856 0
s.tweedy@uq.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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