Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000127606
Ethics application status
Approved
Date submitted
9/12/2013
Date registered
3/02/2014
Date last updated
5/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of manual therapy on the rowing performance of elite kayakers.
Scientific title
The effect of spinal manipulative therapy on the rowing performance of elite kayakers: a cross-over pilot trial.
Secondary ID [1] 283723 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rowing performance 290689 0
Condition category
Condition code
Musculoskeletal 291060 291060 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal manipulation: High velocity low amplitude (HVLA) spinal manipulation to the thoracic spine and associated rib articulations. One intervention session per participant. Each session lasts for 5 minutes.
Stretching routine: Consists of 4 general stretches applied to each side of the body (right and left) and held for 30 seconds each. Total time of stretching routine = 5 minutes.
Participants undergo a 5 minute rowing performance immediately followed by stretching routine which is then immediately followed by spinal manipulation which is then immediately followed by a 2nd 5 minute rowing performance.
This is a crossover trial with a washout period of 48 hours.
Intervention code [1] 288418 0
Treatment: Other
Comparator / control treatment
Active control - stretching routine.
Consists of 4 general stretches applied to each side of the body (right and left) and held for 30 seconds each. The routine is performed at both sessions in the trial after the initial rowing performance but before the spinal manipulation (where applicable).
Participants undergo a 5 minute rowing performance which is then immediately followed by stretching routine which is then immediately followed by a 2nd 5 minute rowing performance.
Control group
Active

Outcomes
Primary outcome [1] 291052 0
Rowing stroke pattern analysis.
Rowing is performed on an ergometer that is positioned within the field of view of a series of fixed position infrared cameras.
Infrared markers are positioned on pre-determined anatomical landmarks on each participant. The cameras record the movement patterns of the infra-red markers.
Timepoint [1] 291052 0
During each rowing performance
Primary outcome [2] 291053 0
Electromyography (EMG) analysis of 8 pairs of muscles: trapezius (lower), rhomboids, latissimus dorsi, serratus posterior inferior, quadratus lumborum, pectoralis major, serratus anterior and external obliques.
Timepoint [2] 291053 0
During each rowing performance
Secondary outcome [1] 305893 0
Spinal range of motion.
Infrared markers are fixed to a number of pre-determined anatomical landmarks on and around the spine. The cameras record movements of these markers during rowing performance.
Timepoint [1] 305893 0
During rowing performance

Eligibility
Key inclusion criteria
Current member of the Australian kayak rowing squad.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently pregnant.
Current injury that prevents them rowing at their 'normal' performance level.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers who have met the trial's inclusion criteria are screened for the presence of contra-indications to spinal manipulative therapy (SMT). Assuming the screening is clear written consent is then obtained form each participant.
As this is a cross-over trial all participants receive both forms of intervention i.e. stretching and SMT. Participants are assigned to receive SMT at either the first or second intervention session. Allocation concealment was achieved using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which a participant receives the interventions is randomised through use of sealed envelopes. Each participant randomly selects a sealed envelope that contains a piece of paper in it that is either blank or has the number 1-8 written on it. The numbers 1-8 represent the group that will receive SMT at the initial intervention session while the blank paper represents the group that will receive SMT at the second intervention session.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot trial a power calculation was not undertaken.

Rowing performance and EMG data will be analysed using the Qualsys software system. They will be compared before and after SMT for each subject.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2013
Actual
22/11/2013
Date of last participant enrolment
Anticipated
Actual
6/12/2013
Date of last data collection
Anticipated
Actual
30/05/2014
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288404 0
University
Name [1] 288404 0
Macquarie University
Country [1] 288404 0
Australia
Funding source category [2] 288405 0
University
Name [2] 288405 0
Charles Sturt University
Country [2] 288405 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 287104 0
None
Name [1] 287104 0
Address [1] 287104 0
Country [1] 287104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290283 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 290283 0
Ethics committee country [1] 290283 0
Australia
Date submitted for ethics approval [1] 290283 0
23/07/2013
Approval date [1] 290283 0
09/10/2013
Ethics approval number [1] 290283 0
5201300540

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

Contacts
Principal investigator
Name 44838 0
Dr Roger Engel
Address 44838 0
Building C5C, Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 44838 0
Australia
Phone 44838 0
+61 2 9850 6387
Fax 44838 0
+61 2 9850 9389
Email 44838 0
[email protected]
Contact person for public queries
Name 44839 0
Roger Engel
Address 44839 0
Building C5C, Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 44839 0
Australia
Phone 44839 0
+61 2 9850 6387
Fax 44839 0
+61 2 9850 9389
Email 44839 0
[email protected]
Contact person for scientific queries
Name 44840 0
Roger Engel
Address 44840 0
Building C5C, Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 44840 0
Australia
Phone 44840 0
+61 2 9850 6387
Fax 44840 0
+61 2 9850 9389
Email 44840 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.