Muscle DamageNCT03707470
Made to Measure Compression Garments for Recovery in Rugby Players
A study testing Custom fitted compression garments (CF) and Standard-sized compression garments (SSG) in people with Muscle Damage, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
Aims To compare the compression pressures exerted by made-to-measure compression garments (CG) with those from standard sized garments To assess the efficacy of custom fitted, high pressure CG for facilitating the recovery of strength, muscular power and sprint performance, and to compare the effects with those of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Custom fitted compression garments (CF) and Standard-sized compression garments (SSG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Actively playing
- A minimum of 2 years training experience.
Who cannot join
- Current injuries or illnesses
- Not actively playing at the time of testing
- Disruptions to training > 2 weeks within 8 weeks prior to testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Made-To-Measure Compression Garments on Pressures Exerted on the Lower Limbs and Recovery From Muscle Damage in Rugby Players
Aims
- To compare the compression pressures exerted by made-to-measure compression garments (CG) with those from standard sized garments
- To assess the efficacy of custom fitted, high pressure CG for facilitating the recovery of strength, muscular power and sprint performance, and to compare the effects with those of garments exerting lower pressures and a sham treatment
Read more
Rationale for study design
The results of a recent meta-analysis (unpublished data) have informed the design of this study. The conclusions of the meta-analysis were that CG are most effective for the recovery of:
- Force and power performance following eccentric/plyometric exercise
- Maximal force production, at least 24 hours post-exercise (for example in strength and power athletes undertaking resistance training programmes)
- Additionally, the recovery of high-intensity cardiovascular performance may also be enhanced by the used of CG, when tested 24 hours following exercise which incurs metabolic stress Accordingly, the current study was designed to investigate the effects of CG on the recovery of force, muscular power and sprint performance in rugby players over a 48 hour period following damaging exercise. The exercise protocol chosen (detailed below) provided both mechanical and metabolic recovery demands.
Read the detailed description
Study 1) A comparison of the pressures exerted by different compression garments Participants were assessed for anthropometry; including height and body-mass, as well as waist, hip thigh, calf, ankle and gluteal circumferences. All limb measurements were taken from the right side, in accordance with guidelines set by the International Society of Anthropometry and Kinanthropometry (ISAK). Skinfold measurements were taken according to the ISAK 8 site protocol by a level 1 anthropometrist.
Thirty-two of the initially recruited 48 participants (see Study 2, below) were randomly selected and fitted for custom fitted compression garments (CG - stockings), after taking real-time 3D images using the manufacturer's proprietary, digitised method (Isobar, Manchester, UK). The custom fitted stockings (CF) were manufactured to apply pressures of 35 mmHg and 20 mmHg for the calf and mid-thigh respectively. Using a crossover design, applied pressures were compared to those from standard sized CG (SSG) which provided lower pressures (5-15 mmHg) for each athlete. Garments were provided in small, medium or large, dependent on athletes' size and fitted according to the manufacturer's guidelines based upon height and body-mass (2XU, Campbelltown, Australia). Pressures at the skin-garment interface were measured for both garments, worn in a randomised order, using a pressure monitor. Pressures applied at three sites were recorded: font-thigh and medial calf landmarks as defined by The International Society for the Advancement of Kinanthropometry (ISAK), and 2 cm above the centre of the median malleolus of the ankle. This visit to the laboratory took approximately 30 minutes per participant. Means and standard deviations were calculated from the pressure data to ascertain the average pressure exerted by the garments, as well as the variation in pressure across this population. Differences in measured pressures between garments were assessed using a paired-samples t-test (SPSS Statistics 22, IBM, New York, USA).
Study 2) An investigation into the effects of the pressures applied by different compression garments in facilitating the short term recovery of strength and power performance The full cohort of 48 athletes originally recruited participated in a randomised clinical trial (parallel design) to assess the effects of CG on recovery from a standardised eccentric exercise protocol. Athletes were required to avoid strenuous exercise for 48 hours before the start of the study, and then throughout 48 hours recovery. The first session included assessment of performance followed by a bout of damaging exercise and re-assessment, lasting approximately 90 minutes. Recovery was assessed in 2 further sessions, at 24 hours and at 48 hours after exercise (each lasting approximately 30 minutes).
Initial assessment Following a standardised warm up (400 m jogging, 20 leg swings in both the horizontal and sagittal planes on either leg, and any individual stretches usually performance by an athlete), maximal force production (using a strain-gauge - MIE Medical Research Ltd., Leeds, UK) was assessed by measuring the best of three attempts of maximal knee extension. Participants will be seated on a plyometric box, starting from a flexed position of 90o, as measured with a goniometer. In addition, 30 m sprint time (timing gates by Brower, Utah, USA) and vertical jump performance, using a jump mat (FSL electronics, Cookstown, UK), were assessed (best of 3 attempts). Soreness (200 mm visual analogue scale) and swelling (spring loaded tape measure - Lafayette Instrument Co, Lafayette, Indiana, USA) were also assessed. Muscle damage was also be quantified by creatine kinase analysis (RX Monza, Kearneysville, West Virginia, USA) from venous blood samples taken from the arm at baseline and at each time-point throughout recovery.
Eccentric muscle-damage protocol Following initial assessment, participants completed 20 sets of 20 m sprints with a 5 m deceleration phase, followed by 100 drop jumps. Sprints were separated by 60 s intervals. This combined protocol represents a novel and ecologically valid stimulus which combines the mechanical and metabolic stressors faced by Rugby Union players from competition and training. Sprints were timed to provide real-time feedback and encourage maximal effort, and sprints repeated if deceleration continued past the 5 m zone permitted. Subsequent drop jumps were performed from a 0.6 m platform, while athletes were encouraged to achieve the maximum height possible following a down-phase that resulted in the hips dropping below the level of the knee.
In a randomised, parallel-group design, athletes undertook either a sham treatment (CON), or wore CG immediately from the cessation of exercise for 48 hours recovery, removing them only to wash. Garments were manufactured to apply the pressures below, with no differences in physical appearance between garments. Athletes were allocated to one of the following three conditions:
- Custom fitted stockings (Isobar, Manchester, UK) applying over 35 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
- Standard sized garments (2XU, Campbelltown, Australia) applying lower pressures (SSG - applying 5-15 mmHg, at both the calf and thigh)
- A sham ultrasound treatment (CON) The CON group received 15 minutes (5 minutes of quadriceps, 5 minutes of hamstrings, and 5 minutes of gastrocnemius) of sham ultrasound therapy (Combined therapy ultrasound/inferential; Shrewsbury Medical, Shropshire, United Kingdom) within 1 hour of the completion of performance testing. Pressures at the skin-garment interface were measured for both garments using a pressure monitor.
Performance measures - dependent variables Recovery was quantified by repeating the initial assessment and comparing to baseline values. Recovery of performance and recovery of markers of muscle damage were measured at the following time-points: pre-exercise, post-exercise, 24 hours post-exercise, 48 hours post-exercise. Between-group differences in the recovery of performance and physiological factors were assessed over time using a 2 way (time by condition) mixed-measures analysis of variance (SPSS Statistics 22, IBM, New York, USA).
All equipment used and methods employed made use of validated measures of strength, power, muscle damage and compression pressures.
- Conditions
- Muscle Damage
- Being tested
- Custom fitted compression garments (CF), Standard-sized compression garments (SSG), Sham ultrasound (CON)
- Keywords
- exercise induced muscle damage, recovery, rugby
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom fitted compression garments (CF)Device
Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments)
Standard-sized compression garments (SSG)Device
Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 10 mmHg at both the ankle and thigh)
Sham ultrasound (CON)Procedure or surgery
Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings
| Study group | Role | What they receive |
|---|---|---|
| Custom fitted compression garments (CF) | Experimental | Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments) Receives: Device: Custom fitted compression garments (CF) |
| Standard-sized compression garments (SSG) | Active comparator | Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 15 mmHg at both the ankle and thigh) Receives: Device: Standard-sized compression garments (SSG) |
| Sham ultrasound (CON) | Sham comparator | Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings Receives: Procedure: Sham ultrasound (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower body strength
Change in maximal voluntary isometric contraction force of the knee extensors over time, measured in Newtons, using a force-meter to measure knee flexion force at 90 degrees
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Change in lower body jump performance
Change in maximal force from counter-movement jump over time, measured on a force platform (Newtons)
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Change in sprint speed
Change in 30 m sprint speed over time, measured using electronic timing gates
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Secondary outcomes (4)
Change in total haemoglobin concentration (tHb)
Accumulation of total haemoglobin, as measured with NIRS
Measured: Immediately post-exercise, after having gone from the supine position (5 min), to standing (5 min)
Change in perceived soreness
Change in perceived muscle soreness over time, measured by participants marking a line on a 200 mm visual analogue scale (from 0 mm - "no soreness"; to 200 mm - "worst soreness imaginable")
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Change in creatine kinase concentrations (CK)
Change in creatine kinase concentrations (IU) over time
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Change in mid-thigh girth (MTG)
Change in mid-thigh girth (cm) over time
Measured: Immediately post, 24 hours post, 48 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Nov 2016
- Primary completion1 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, parallel trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707470
- Sponsor's protocol ID
- SMU_SHAS_2017_03
- Status last verified
- Oct 2018
- First submitted
- 7 Jun 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical, Study Report (CSR) all available on request.
Publications
Brophy-Williams N, Driller M, Halson S, Fell J, Shing C. Evaluating the Kikuhime pressure monitor for use with sports compression clothing. Sports Engineering. 2014;17(1):55-60.
Jakeman JR, Byrne C, Eston RG. Lower limb compression garment improves recovery from exercise-induced muscle damage in young, active females. Eur J Appl Physiol. 2010 Aug;109(6):1137-44. doi: 10.1007/s00421-010-1464-0. Epub 2010 Apr 8.
PubMed 20376479Leeder J DC, van Someren KA, Gaze D, Jewell A, Deshmukh NI, Shah I, Barker J, Howatson G. Recovery and adaptation from repeated intermittent-sprint exercise. Int J Sports Physiol Perform. 2014 May;9(3):489-96. doi: 10.1123/ijspp.2012-0316. Epub 2013 Mar 8.
PubMed 23479406
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Made-To-Measure Compression Garments on Pressures Exerted on the Lower Limbs and Recovery From Muscle Damage in Rugby Players
- ClinicalTrials.gov ID
- NCT03707470
- Acronym / sponsor ID
- SMU_SHAS_2017_03
- Conditions
- Muscle Damage
- Keywords
- exercise induced muscle damage, recovery, rugby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims
- To compare the compression pressures exerted by made-to-measure compression garments (CG) with those from standard sized garments
- To assess the efficacy of custom fitted, high pressure CG for facilitating the recovery of strength, muscular power and sprint performance, and to compare the effects with those of garments exerting lower pressures and a sham treatment
Rationale for study design
The results of a recent meta-analysis (unpublished data) have informed the design of this study. The conclusions of the meta-analysis were that CG are most effective for the recovery of:
- Force and power performance following eccentric/plyometric exercise
- Maximal force production, at least 24 hours post-exercise (for example in strength and power athletes undertaking resistance training programmes)
- Additionally, the recovery of high-intensity cardiovascular performance may also be enhanced by the used of CG, when tested 24 hours following exercise which incurs metabolic stress Accordingly, the current study was designed to investigate the effects of CG on the recovery of force, muscular power and sprint performance in rugby players over a 48 hour period following damaging exercise. The exercise protocol chosen (detailed below) provided both mechanical and metabolic recovery demands.
Detailed description
Study 1) A comparison of the pressures exerted by different compression garments Participants were assessed for anthropometry; including height and body-mass, as well as waist, hip thigh, calf, ankle and gluteal circumferences. All limb measurements were taken from the right side, in accordance with guidelines set by the International Society of Anthropometry and Kinanthropometry (ISAK). Skinfold measurements were taken according to the ISAK 8 site protocol by a level 1 anthropometrist.
Thirty-two of the initially recruited 48 participants (see Study 2, below) were randomly selected and fitted for custom fitted compression garments (CG - stockings), after taking real-time 3D images using the manufacturer's proprietary, digitised method (Isobar, Manchester, UK). The custom fitted stockings (CF) were manufactured to apply pressures of 35 mmHg and 20 mmHg for the calf and mid-thigh respectively. Using a crossover design, applied pressures were compared to those from standard sized CG (SSG) which provided lower pressures (5-15 mmHg) for each athlete. Garments were provided in small, medium or large, dependent on athletes' size and fitted according to the manufacturer's guidelines based upon height and body-mass (2XU, Campbelltown, Australia). Pressures at the skin-garment interface were measured for both garments, worn in a randomised order, using a pressure monitor. Pressures applied at three sites were recorded: font-thigh and medial calf landmarks as defined by The International Society for the Advancement of Kinanthropometry (ISAK), and 2 cm above the centre of the median malleolus of the ankle. This visit to the laboratory took approximately 30 minutes per participant. Means and standard deviations were calculated from the pressure data to ascertain the average pressure exerted by the garments, as well as the variation in pressure across this population. Differences in measured pressures between garments were assessed using a paired-samples t-test (SPSS Statistics 22, IBM, New York, USA).
Study 2) An investigation into the effects of the pressures applied by different compression garments in facilitating the short term recovery of strength and power performance The full cohort of 48 athletes originally recruited participated in a randomised clinical trial (parallel design) to assess the effects of CG on recovery from a standardised eccentric exercise protocol. Athletes were required to avoid strenuous exercise for 48 hours before the start of the study, and then throughout 48 hours recovery. The first session included assessment of performance followed by a bout of damaging exercise and re-assessment, lasting approximately 90 minutes. Recovery was assessed in 2 further sessions, at 24 hours and at 48 hours after exercise (each lasting approximately 30 minutes).
Initial assessment Following a standardised warm up (400 m jogging, 20 leg swings in both the horizontal and sagittal planes on either leg, and any individual stretches usually performance by an athlete), maximal force production (using a strain-gauge - MIE Medical Research Ltd., Leeds, UK) was assessed by measuring the best of three attempts of maximal knee extension. Participants will be seated on a plyometric box, starting from a flexed position of 90o, as measured with a goniometer. In addition, 30 m sprint time (timing gates by Brower, Utah, USA) and vertical jump performance, using a jump mat (FSL electronics, Cookstown, UK), were assessed (best of 3 attempts). Soreness (200 mm visual analogue scale) and swelling (spring loaded tape measure - Lafayette Instrument Co, Lafayette, Indiana, USA) were also assessed. Muscle damage was also be quantified by creatine kinase analysis (RX Monza, Kearneysville, West Virginia, USA) from venous blood samples taken from the arm at baseline and at each time-point throughout recovery.
Eccentric muscle-damage protocol Following initial assessment, participants completed 20 sets of 20 m sprints with a 5 m deceleration phase, followed by 100 drop jumps. Sprints were separated by 60 s intervals. This combined protocol represents a novel and ecologically valid stimulus which combines the mechanical and metabolic stressors faced by Rugby Union players from competition and training. Sprints were timed to provide real-time feedback and encourage maximal effort, and sprints repeated if deceleration continued past the 5 m zone permitted. Subsequent drop jumps were performed from a 0.6 m platform, while athletes were encouraged to achieve the maximum height possible following a down-phase that resulted in the hips dropping below the level of the knee.
In a randomised, parallel-group design, athletes undertook either a sham treatment (CON), or wore CG immediately from the cessation of exercise for 48 hours recovery, removing them only to wash. Garments were manufactured to apply the pressures below, with no differences in physical appearance between garments. Athletes were allocated to one of the following three conditions:
- Custom fitted stockings (Isobar, Manchester, UK) applying over 35 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
- Standard sized garments (2XU, Campbelltown, Australia) applying lower pressures (SSG - applying 5-15 mmHg, at both the calf and thigh)
- A sham ultrasound treatment (CON) The CON group received 15 minutes (5 minutes of quadriceps, 5 minutes of hamstrings, and 5 minutes of gastrocnemius) of sham ultrasound therapy (Combined therapy ultrasound/inferential; Shrewsbury Medical, Shropshire, United Kingdom) within 1 hour of the completion of performance testing. Pressures at the skin-garment interface were measured for both garments using a pressure monitor.
Performance measures - dependent variables Recovery was quantified by repeating the initial assessment and comparing to baseline values. Recovery of performance and recovery of markers of muscle damage were measured at the following time-points: pre-exercise, post-exercise, 24 hours post-exercise, 48 hours post-exercise. Between-group differences in the recovery of performance and physiological factors were assessed over time using a 2 way (time by condition) mixed-measures analysis of variance (SPSS Statistics 22, IBM, New York, USA).
All equipment used and methods employed made use of validated measures of strength, power, muscle damage and compression pressures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomised, controlled, parallel trial
| Arm | Type | Receives |
|---|---|---|
| Custom fitted compression garments (CF) | Experimental | Device: Custom fitted compression garments (CF)Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments) |
| Standard-sized compression garments (SSG) | Active comparator | Device: Standard-sized compression garments (SSG)Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 15 mmHg at both the ankle and thigh) |
| Sham ultrasound (CON) | Sham comparator | Procedure: Sham ultrasound (CON)Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Actively playing
- A minimum of 2 years training experience.
Key exclusion criteria (3 listed)
- Current injuries or illnesses
- Not actively playing at the time of testing
- Disruptions to training > 2 weeks within 8 weeks prior to testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom fitted compression garments (CF)Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments) | Device | Custom fitted compression garments (CF) |
| Standard-sized compression garments (SSG)Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 10 mmHg at both the ankle and thigh) | Device | Standard-sized compression garments (SSG) |
| Sham ultrasound (CON)Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings | Procedure or surgery | Sham ultrasound (CON) |
Primary outcome
Change in lower body strength
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Change in maximal voluntary isometric contraction force of the knee extensors over time, measured in Newtons, using a force-meter to measure knee flexion force at 90 degrees
Change in lower body jump performance
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Change in maximal force from counter-movement jump over time, measured on a force platform (Newtons)
Change in sprint speed
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Change in 30 m sprint speed over time, measured using electronic timing gates
4 secondary outcomes
Change in total haemoglobin concentration (tHb)
Time frame: Immediately post-exercise, after having gone from the supine position (5 min), to standing (5 min)
Change in perceived soreness
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Change in creatine kinase concentrations (CK)
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Change in mid-thigh girth (MTG)
Time frame: Immediately post, 24 hours post, 48 hours post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- BackgroundBrophy-Williams N, Driller M, Halson S, Fell J, Shing C. Evaluating the Kikuhime pressure monitor for use with sports compression clothing. Sports Engineering. 2014;17(1):55-60.
- Background: PubMed 20376479Jakeman JR, Byrne C, Eston RG. Lower limb compression garment improves recovery from exercise-induced muscle damage in young, active females. Eur J Appl Physiol. 2010 Aug;109(6):1137-44. doi: 10.1007/s00421-010-1464-0. Epub 2010 Apr 8.
- Background: PubMed 23479406Leeder J DC, van Someren KA, Gaze D, Jewell A, Deshmukh NI, Shah I, Barker J, Howatson G. Recovery and adaptation from repeated intermittent-sprint exercise. Int J Sports Physiol Perform. 2014 May;9(3):489-96. doi: 10.1123/ijspp.2012-0316. Epub 2013 Mar 8.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical, Study Report (CSR) all available on request.
Related trials for Muscle Damage
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom fitted compression garments (CF) and Standard-sized compression garments (SSG) in people with Muscle Damage, run by St Mary's University College at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower body strength (time frame: Immediately post, 24 hours post, 48 hours post-exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.