Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001193561
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Red Light on Performance in Trained Rowers
Scientific title
The effect of red and near-infrared light on exercise performance in rowers
Secondary ID [1] 312917 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen consumption 335081 0
Condition category
Condition code
Cardiovascular 331584 331584 0 0
Normal development and function of the cardiovascular system
Respiratory 331643 331643 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to attend four exercise sessions at a University of sports laboratory where they will be exposed to either red light (630 & 660 nm), infra-red light (810, 830, and, 850 nm), combined red and infra-red light, or a placebo (device turned on, but paused so no light is emitted), The light will be delivered with participants standing in front of the phototherapy device (SOHL® Complete) at a distance of 30 cm for 5 minutes,
A researcher will accompany the participant into a private, windowless room in a University of Waikato campus laboratory. They will give instructions to the participant, position them in front of the phototherapy device, and provide them with the eye-protection. Adherence will be assessed verbally during and after the intervention.

Participants will be exposed to one of either red light (630 & 660 nm), infra-red light (810, 830, and 850 nm), combined red and infra-red light (630 & 660, 810, 830, and 850 nm), or a placebo in a randomised order during the four separate visits to the laboratory.

Immediately after the light exposure, the participants will perform 7, 3 minute submaximal exercise bouts on a rowing ergometer. Each bout of submaximal exercise will be separated by 2 minutes rest and each visit to the laboratory will be separated by at least 3 days.
Intervention code [1] 329450 0
Treatment: Devices
Comparator / control treatment
No phototherapy light exposure.
Control group
Placebo

Outcomes
Primary outcome [1] 339323 0
Oxygen consumption
Timepoint [1] 339323 0
Immediately post treatment. Note that the participant will attend four session separated by at least 3 days where the specific light exposure will be randomly assigned in a counterbalanced cross-over manner. The outcome measure will be assessed once per visit immediately following the light exposure.
Secondary outcome [1] 439452 0
Perceived exertion
Timepoint [1] 439452 0
Immediately after each submaximal exercise bout the participant will be asked to indicate how hard they felt the exercise was using a validated perceived exertion scale. Therefore, this will occur 7 times per visit and 28 times in total.

Eligibility
Key inclusion criteria
18-30 years old
male and female rowers
No history of photosensitivity
No current injury that could be aggravated by submaximal rowing.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
The researcher who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation was concealed by having the participant blindly select their allocation order for the four laboratory visits from an opaque container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random selection
Simple randomisation was achieved using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/08/2024
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
16
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 26549 0
New Zealand
State/province [1] 26549 0

Funding & Sponsors
Funding source category [1] 317349 0
University
Name [1] 317349 0
University of Waikato
Country [1] 317349 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 319637 0
None
Name [1] 319637 0
Address [1] 319637 0
Country [1] 319637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316080 0
University of Waikato Human Research Ethics Committee (Health)
Ethics committee address [1] 316080 0
Ethics committee country [1] 316080 0
New Zealand
Date submitted for ethics approval [1] 316080 0
31/05/2024
Approval date [1] 316080 0
13/08/2024
Ethics approval number [1] 316080 0
HREC(Health)2024#27

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

Contacts
Principal investigator
Name 136714 0
Dr Martyn Beaven
Address 136714 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136714 0
New Zealand
Phone 136714 0
+64 225030577
Fax 136714 0
Email 136714 0
martyn.beaven@waikato.ac.nz
Contact person for public queries
Name 136715 0
Martyn Beaven
Address 136715 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136715 0
New Zealand
Phone 136715 0
+64 225030577
Fax 136715 0
Email 136715 0
martyn.beaven@waikato.ac.nz
Contact person for scientific queries
Name 136716 0
Martyn Beaven
Address 136716 0
University of Waikato Adams Centre for High Performance, 52 Miro St, 3116, Tauranga
Country 136716 0
New Zealand
Phone 136716 0
+64 225030577
Fax 136716 0
Email 136716 0
martyn.beaven@waikato.ac.nz

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.