Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000098134
Ethics application status
Approved
Date submitted
18/01/2019
Date registered
23/01/2019
Date last updated
1/07/2021
Date data sharing statement initially provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two different recovery strategies on post-exercise blood flow and recovery.
Scientific title
Influence of sports compression garments on post-exercise blood flow and muscle recovery in healthy and resistance trained volunteers..
Secondary ID [1] 297136 0
Nil known
Universal Trial Number (UTN)
U1111-1227-0190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle recovery 311166 0
Condition category
Condition code
Musculoskeletal 309783 309783 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 309784 309784 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 BRIEF NAME
Sports Compression Garments (SCG)
2 WHY
Sports compression garments (SCG) are commonly used in athletes to improve recovery from exercise. The mechanisms by which SCG improve recovery are largely unknown, but may be closely associated with alterations in blood flow. As such, SCG have been implicated in increasing venous return, thereby assisting the removal of muscle metabolites post-exercise and preventing secondary muscle damage. However, research investigating the effects of SCG on blood flow, particularly during the post-exercise period, is limited. This research aims to investigate the effects of SCG on markers of venous return and muscle blood flow post-exercise, and the influence this has on aspects of muscle recovery.
3 MATERIALS
Materials: SCG tights (https://www.2xu.com/au/p/refresh--recovery-tights/MA4419b.html?dwvar_MA4419b_color=BLACK_NERO&lang=en_AU#prefn1=restrictedProduct&prefv1=no&lang=en_AU&start=1) will be provided by sports apparel company, 2XU.
4. PROCEDURES
Participants will complete a lower-body resistance training session (outlined below) followed by an assigned recovery intervention of either SCG tights, placebo (artificial sweetener) or control.
One Rep Max Testing: Participants will be testing to determine their 1RM for leg press. This 1RM data will be used to set an individual workload for the lower-body resistance training session during visit 2. Prior to testing of 1RM, subjects will perform a standardized warm-up consisting of 5 min cycling at 1 W per kg body mass, 10 repetitions of body weight squats, 10 repetitions on each leg of bodyweight walking lunges, high knee run over 20 m, heel kick run over 20 m, 3 submaximal CMJs and 1 maximal CMJ. Following the warm-up, participants will perform a total of two warm-up sets, 10 reps with no weight on the leg press machine followed by 5 reps at 50% of estimated 1RM. Participants will then perform a repetition at an estimated 90% of 1RM. If repetition is completed successfully, and with correct technique, participants will perform another one repetition effort with gradually increasing resistance until failure or loss of technique. A 3 min rest period will be allowed between max effort attempts. A successful 1RM will be the greatest mass lifted with the correct form through a complete range of motion. Due to maximal testing for determination of 1RM, a 7-day period will be required between visits 1 and 2.
Lower-Body Resistance Training Session: After the completion of performance tests, subjects will perform a lower-body resistance training session. Subjects will perform leg presses that emphasise the eccentric movement, for 8 sets of 6 reps. Weight lifted for 6 reps will be approximately 85% of previously tested 1RM (1). Subjects will assume a seated position on the leg press machine, and place feet shoulder-width apart and flat on the platform. Subjects will be required to lower the resistance platform slowly for a duration of 4 s (time recorded by investigator) and then push the platform back to starting position by extending the legs until knees are only slightly bent. This will be considered one rep. A 3 min rest period will be taken between each set. Prior to the beginning of 8 sets, participants will perform a total of two warm-up sets, 10 reps with no weight on the leg press machine and 8 reps at 50% of 1RM. A spotter will be positioned on each side of the machine to assist in the concentric (pushing) phase in the event participants experience local fatigue. A similar protocol has been shown to result in increased creatine kinase levels and ratings of perceived muscle soreness at 24 and 48 h post-exercise.
5 WHO PROVIDED
SCG tights will be provided to participants by Mr Shane O’Riordan. Mr O’Riordan is a PhD student at Victoria University in Exercise Physiology. Mr O’Riordan has conducted previous research using SCG as part of his PhD research with Victoria University in Sport Physiology. In addition, Mr O’Riordan works at the Australian Institute of Sport as a recovery physiologist, where he regularly prescribes the use of SCG as a recovery modality for athletes.
6 HOW
SCG tights will be provided to the participants individually post-exercise face to face.
7 WHERE
The intervention of SCG tights will occur at the Exercise Physiology Laboratory, Building P, Room PB151, Victoria University, Ballarat Rd, Footscray, VIC, 3011.
8 WHEN and HOW MUCH
The intervention of SCG tights will be provided post-exercise for a duration of four hours. After the four hour recovery period, participants will remove SCG tights.
9 TAILORING
The degree of pressure applied and gradient distribution are critical for the effectiveness of SCG. Manufacturer fitting guidelines are typically acquired from an individual’s height and weight, meaning anthropometric variations in limb size and structure are likely to affect the pressure exerted by SCG. Therefore, the level of pressure exerted by SCG will be measured using the kikuhime device. This device contains a small air-filled piece of plastic that is placed between the garment and the skin. The pressure applied by the garment is then displayed on a monitor in real time, and to the nearest mmHg. Pressure will be measured at six sights on the right lower-limb. SCG will have a desired target pressure (23-32 mmHg at the calf and 12-17 mmHg at the thigh). In the event target pressure is not achieved, another SCG will be tested until the desired pressure is achieved and appropriate sizes noted for each participant. Assignment of SCG will be determined during the first visit for the SCG group.
Intervention code [1] 313400 0
Prevention
Intervention code [2] 313401 0
Treatment: Devices
Comparator / control treatment
There is two comparator/control treatment groups in this trial. One group will receive a Placebo (PLA) post exercise, with the other group acting as a Control (CON). For the PLA condition, participants will be required to ingest a calorie-free artificial sweetener tablet (Hermesetas, Stevia Sweet Tablets) at 4-time points (0, 1, 2 and 3 h after post-exercise testing). This tablet (55 mg) will act as a placebo by deception, with a total of 220 mg of calorie-free artificial sweetener ingested during this study. Participants will be provided with an information sheet falsely describing the tablet as L-Arginine, and promoting its ability to improve blood flow and recovery from exercise, similar to the promoted effects of SCG. Participants in the CON group will not receive any intervention but will remain supine for 4 h post-exercise
Control group
Placebo

Outcomes
Primary outcome [1] 318742 0
Muscle blood flow (Composite Primary Outcome):
Muscle blood flow and muscle oxygenation will be measured at the vastus lateralis and gastrocnemius medialis muscles using Near Infrared Spectroscopy (NIRS). An oximeter will be positioned on the lowest third of the vastus lateralis muscle, parallel to the long axis of the leg. A second oximeter will be positioned on the gastrocnemius medialis muscle belly, parallel to the major axis of the shin of the same leg. Each placement site will be shaved of excess hair to help ensure a good quality signal. The placement of each oximeter will be marked with a permanent marker to ensure consistency for each testing session (visit 2, 3 and 4). The NIRS device provides continuous, non-invasive measurement of concentration changes in oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb) and total haemoglobin (tHb). Changes in muscle oxygenation will be monitored using an oximeter (Oxymon MKIII Near-Infrared Spectrophotometer, Artinins Medical Systems, The Netherlands), with data transmitted simultaneously to a personal computer and acquired using (Oxysoft V3.0.53, Artinins Medical Systems, The Netherlands) software. To assess muscle blood flow, multiple venous occlusions (70 mmHg) will be performed. This technique requires the inflation of a pressure cuff, applied to the upper thigh, using an automated rapid cuff inflation system (Hokanson, Washington, USA). Blood flow into the muscle is then calculated by the rise in tHb (O2Hb + HHb). Three 20-s venous occlusions, separated by 45 s of rest. The average of these three measurements will be used for data analysis.
Timepoint [1] 318742 0
Pre-exercise
Immediately post-exercise and every 30 minutes for 4 hours (4 hours post is primary timepoint)
24 and 48 hours post-exercise
Primary outcome [2] 318743 0
Markers of Venous Return (Composite primary outcome):
Doppler ultrasound will be used to measure markers of venous return (venous cross-sectional area, venous peak flow velocity and venous mean flow velocity) for the popliteal (behind the knee) and common femoral (upper-thigh) veins. Each site will marked with a permanent marker to ensure consistency at each collection time point. Lubricating jelly will be applied to the skin at each site to help transmit the signal. Measures at the common femoral vein will be accessed with the garments folded down slightly. A small window will be cut in the garments, before participant is wearing SCG, to allow probe access to the popliteal vein. The angle of the transducer relative to the skin will be between 45 and 60 degrees, with the depth adjusted to insonate the total width of the veins. Ultrasound signal will be measured for approximately 60s at each site in order to obtain measures of venous return previously mentioned. Personnel trained in the use of ultrasound for venous measures will collect all measures.
Timepoint [2] 318743 0
Pre-exercise
Immediately post-exercise and every 30 minutes for 4 hours (4 hours post is primary timepoint)
24 and 48 hours post-exercise
Primary outcome [3] 318744 0
Blood Samples (Composite Primary Outcome):
An indwelling cannulation will be inserted into an antecubital vein for the collection of 4-mL blood samples. Blood samples will be analysed for markers of muscle damage (creatine kinase and C-reactive protein) using commercially available kits (R&D Multiplex ELISA Kit). Samples will be collected, stored, and prepared as per manufacturer guidelines. Cannulations and blood collections will be undertaken by trained personnel under sterile conditions.
Timepoint [3] 318744 0
Pre Exercise
Immediately post-exercise and every 60 min for 4 hours
24 and 48 (primary time point) hours post-exercise
Secondary outcome [1] 365907 0
Performance Tests
To assess performance recovery following exercise countermovement jumps (CMJ) will be performed.

Prior to all performance tests, subjects will perform a standardized warm-up consisting of 5 min cycling at 1 W per kg body mass, 10 repetitions of body weight squats, 10 repetitions on each leg of bodyweight walking lunges, high knee run over 20 m, heel kick run over 20 m, 3 submaximal CMJs and 1 maximal CMJ.

The CMJ is a valid and reliable test for estimating explosive power of the lower limb. The CMJ test will be performed with subjects standing on a force place with feet in a hip wide position. Participants will be required to perform a quick downward movement to approx. 90° knee flexion, followed by a fast upward vertical jump as high as possible. Upon landing, both feet will be required to be within the frames of the force plate. When performing the CMJ, hands will be placed on hips to eliminate influence of arm swing on jump performance. A set of 5 CMJs will be completed, with 8 seconds rest between repetitions. Vertical ground reaction forces (N) and jump height (cm) will be used for analysis.
Timepoint [1] 365907 0
Pre Exercise
Immediately post-exercise
24 and 48 hours post-exercise
Secondary outcome [2] 365908 0
Total quality of recovery (TQR) Questionnaire:
This will be assessed by participants rating their perceived recovery on a scale from 6 (no recovery) to 20 (maximal recovery). This questionnaire has previously been used and validated.
Timepoint [2] 365908 0
Pre Exercise
Immediately post-exercise and every 60 min for 4 hours
24 and 48 hours post-exercise
Secondary outcome [3] 365950 0
Blood Samples (Composite Primary Outcome):
An indwelling cannulation will be inserted into an antecubital vein for the collection of 4-mL blood samples. Blood samples will be analysed for pro and anti-inflammatory markers (IL-1ß, IL-6, IL-10, IL-4) using commercially available kits (R&D Multiplex ELISA Kit). Samples will be collected, stored, and prepared as per manufacturer guidelines. Cannulations and blood collections will be undertaken by trained personnel under sterile conditions.
Timepoint [3] 365950 0
Pre Exercise
Immediately post-exercise and every 60 min for 4 hours
24 and 48 hours (primary timepoint) post-exercise
Secondary outcome [4] 365951 0
To assess performance recovery following exercise, isometric mid-thigh pulls (IMTP) will be performed.

Prior to all performance tests, subjects will perform a standardized warm-up consisting of 5 min cycling at 1 W per kg body mass, 10 repetitions of body weight squats, 10 repetitions on each leg of bodyweight walking lunges, high knee run over 20 m, heel kick run over 20 m, 3 submaximal CMJs and 1 maximal CMJ.

The IMTP is a reliable assessment of whole-body maximum force generating capacity, and is regularly used to monitors athletes’ training progression. The test will be performed on a Smith Machine while standing on a force platform. The mid-thigh position will be determined by marking the midpoint between the top of the patella and the inguinal crease of the front thigh. This site will be marked with a permanent marker, along with feet position, to ensure retest reliability. Participants will self-select their hip and knee angles for the test with the height of the barbell adjusted to be in contact with the marked mid-thigh position. Participants will be instructed to pull upward on an immovable bar for 3 seconds while standing on the force platform. Two repetitions will be performed separated by 2 min rest, with a third repetition performed if a 250 N difference is seen between peak forces of the first two efforts. Peak force (N) and rate of force development (N/s) will be used for analysis.
Timepoint [4] 365951 0
Pre Exercise
Immediately post-exercise
24 and 48 hours post-exercise
Secondary outcome [5] 365952 0
Perceived muscle soreness (PMS) Questionnaire:
This will be assessed via self-palpation of the exercised muscle, where the participant will be asked to rate their level of soreness using a visual analogue scale (0 = nothing at all, 10 = extremely high). This questionnaire has been used in other research previously.
Timepoint [5] 365952 0
Pre Exercise
Immediately post-exercise and every 60 min for 4 hours
24 and 48 hours post-exercise
Secondary outcome [6] 365953 0
Belief Questionnaire - Immediately following the familiarisation session, participants will be asked to complete a ‘belief questionnaire’. This questionnaire is designed to assess the participant’s anticipated belief in both recovery intervention’s effectiveness. Participants will be asked to rate anticipated effectiveness on a 0 to 5-point Likert scale, with 0 representing ‘not effective at all’ and 5 representing ‘extremely effective’. Participants will be allocated their recovery intervention, matched and counterbalanced based on their anticipated effectiveness in both interventions. Participants will also be asked to complete a belief questionnaire immediately after the last testing session (visit 4), which is designed to assess the participant’s perceived effectiveness of the completed recovery intervention. This questionnaire has been designed specifically but has been used previously.
Timepoint [6] 365953 0
Pre study
Post-study - immediately after the last testing session is complete (visit 4).

Eligibility
Key inclusion criteria
There will be inclusion criteria by which participants must meet in order to be considered for the study. Participants will be required to have performed between 2 to 4 resistance training session a week, for a minimum of six months. Furthermore, participants usual resistance training sessions will include lower body exercises such as squats or deadlifts due to the eccentric component of the exercise protocol in the study. This will be assessed by potential participants completing a Physical Activity Questionnaire before being accepted to participate in the study. The justification for this inclusion criteria is that participants of similar training experience will be recruited, in an attempt to minimize large variations in response to the exercise protocol.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently suffering from any musculoskeletal injury.
Any suspected cardiovascular complications.
Not performing 2 to 4 resistance training session a week for a minimum of six months.
Not including squats or deadlifts in resistance training sessions.
Any contraindications which may result in exercise being unsafe for the participant.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a moderate difference (d=0.54) at a = 0.05 and ß = 0.2 requires a sample size of 24. Cohen's d was calculated from reported differences (Bringard et al. 2006) in calf blood flow with and without lower leg compression garments. In addition, we aim to recruit 10-15% more participants than the number G*Power recommends to allow for potential dropout.

All data will be reported as means ± standard deviation and analysed using IBM SPSS Statistics (IBM Corp., Chicago, Il, USA). Comparisons between recovery interventions will be analysed using a two-way repeated measures ANOVA, where the between-subject factor will be the recovery intervention (CON vs. COMP vs. PLA) and within-subject factor will be time. Significance will be set at a level of p < 0.05. Where significant main effects or interactions occur, a Bonferroni post-hoc analysis will be used. Effect sizes (ES) will also be calculated to assess the magnitude of observed effects. Cohen’s conventions for ES (with 95% confidence intervals) will be used for interpretation. ES = 0.2, 0.5 and 0.8 will be considered small, medium and large, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2019
Actual
27/05/2019
Date of last participant enrolment
Anticipated
2/03/2020
Actual
10/02/2020
Date of last data collection
Anticipated
20/03/2020
Actual
26/02/2020
Sample size
Target
24
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25433 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 301695 0
Commercial sector/Industry
Name [1] 301695 0
2XU Pty. Ltd.
Country [1] 301695 0
Australia
Funding source category [2] 301696 0
University
Name [2] 301696 0
Victoria University
Country [2] 301696 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray, VIC, 3011
Country
Australia
Secondary sponsor category [1] 301419 0
Government body
Name [1] 301419 0
Australian Institute of Sport
Address [1] 301419 0
Leverrier St, Bruce, ACT, 2617
Country [1] 301419 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302415 0
VU Human Research Ethics Committee (VUHREC)
Ethics committee address [1] 302415 0
Ethics committee country [1] 302415 0
Australia
Date submitted for ethics approval [1] 302415 0
21/11/2018
Approval date [1] 302415 0
23/01/2019
Ethics approval number [1] 302415 0
HRE18-227

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

Contacts
Principal investigator
Name 90166 0
Mr Shane O'Riordan
Address 90166 0
Institute for Health and Sport, Ballarat Rd, Footscray VIC 3011
Country 90166 0
Australia
Phone 90166 0
+61 414703872
Fax 90166 0
Email 90166 0
[email protected]
Contact person for public queries
Name 90167 0
Shane O'Riordan
Address 90167 0
Institute for Health and Sport, Ballarat Rd, Footscray VIC 3011
Country 90167 0
Australia
Phone 90167 0
+61 414703872
Fax 90167 0
Email 90167 0
[email protected]
Contact person for scientific queries
Name 90168 0
Shane O'Riordan
Address 90168 0
Institute for Health and Sport, Ballarat Rd, Footscray VIC 3011
Country 90168 0
Australia
Phone 90168 0
+61 414703872
Fax 90168 0
Email 90168 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
Data from this trial will be present as group averages, therefore individual data will not be presented or available


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.