Athletic PerformanceNCT04375163
Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes
A study testing Isokinetic intense exercise protocol and Massage treatment in people with Athletic Performance, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Isokinetic intense exercise protocol and Massage treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2020to 20 Jun 2020
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Professional athletes
- Age range between 18-25.
Who cannot join
- Conduction of any strengthening exercises on the day before the tests
- Musculoskeletal injury during the last six months
- Background of knee trauma and/or surgery
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education and Sports Sciences
Thessaloniki, Central Makedonia, 57001
About this study
Official title: Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes on Knee Range of Motion, Thigh Circumference and Delayed Onset Muscle Soreness
26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (NMG) the break was passive.
Read the detailed description
Objective: Τo investigate the effects of massage in athletic performance when applied during intervals of an intense isokinetic exercise protocol for knee extensor muscles.
Design: Randomized Controlled Trial. Participants: 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (CG) the break was passive.
Main Outcome Measures: knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
- Conditions
- Athletic Performance
- Being tested
- Isokinetic intense exercise protocol, Massage treatment
- Keywords
- sport massage, delayed onset muscle soreness, muscles recovery, continuous concentric eccentric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic intense exercise protocolOther
The isokinetic protocol included 6 sets of 10 maximum efforts at 60 °/s of one leg with a 2-minute break between the sets.
Massage treatmentOther
Massage consisted of stroking (30") and petrissage (50") for muscle relaxation, then friction (10"), pincement and clapping (30") to prepare muscles for the next set.
| Study group | Role | What they receive |
|---|---|---|
| Massage group (ME) | Experimental | A sport massage was applied between the sets of an intense isokinetic exercise protocol for knee extensor muscles Receives: Other: Isokinetic intense exercise protocol; Other: Massage treatment |
| Control | Active comparator | the break between the sets of an intense isokinetic exercise protocol for knee extensor muscles was passive Receives: Other: Isokinetic intense exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Active Knee Range of Motion (ROM)
The ROM of knee flexion and extension was measured before and after the exercise program application in both trials. In particular, the active knee extension was measured in the supine position and the active flexion in the prone position using a universal type goniometer.
Measured: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
Changes in creatine kinase (CK) levels in blood plasma
Blood samples were taken before and 24 hours after the isokinetic protocol to determine whether the exercise program caused fatigue and muscle damage. The blood sample was analyzed to determine CK activity levels in blood plasma using an in-vitro quantitative assay followed by a photometer
Measured: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
Changes in thigh circumference
The circumference of the thigh was measured with a tape measure before the test and after the exercise program at fixed spots at a distance of 10 and 20 cm from the center of the patella
Measured: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
Changes in Delayed Onset Muscle Soreness (DOMS)
The DOMS measurement for the lower extremities (L-DOMS) was performed with the VAS scale 24, 48, 72 and 96 hours after the completion of the program. The VAS scale was tentative where 1 corresponded to "no soreness" and 10 to "very, very sore". The L-DOMS was assessed according to Doma et al1,22 and according to Jakeman et al, through questioning after they completed a body weight squat until their knees were flexed to approximately 90°
Measured: day 1: 24, 48, 72 and 96 hours after-exercise, day 10: 24, 48, 72 and 96 hours after-exercise
Secondary outcomes (1)
Changes in concentric and eccentric torque
During the baseline testing session, the maximum concentric and eccentric torque of knee extensors at 60 °/s was measured with the Cybex Norm.The participant then sat in the armchair of the isokinetic dynamometer with his arms crossed in the chest. Two crossed straps held the torso firmly on the back of the armchair and a belt with an additional strap held the pelvis still. Each participant performed 3 maximal efforts with each leg and the best of the 3 efforts was recorded.
Measured: day 1: pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 May 2020
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (ME) a sport massage was applied between the sets while in the control group (NME) the break was passive. knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evaggelos Sykaras, Aristotle University Of Thessaloniki
- Investigators
- Evaggelos Sykaras, Study director, Department of Physical Education and Sports Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375163
- Sponsor's protocol ID
- EC-9/2020
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes on Knee Range of Motion, Thigh Circumference and Delayed Onset Muscle Soreness
- ClinicalTrials.gov ID
- NCT04375163
- Acronym / sponsor ID
- EC-9/2020
- Conditions
- Athletic Performance
- Keywords
- sport massage, delayed onset muscle soreness, muscles recovery, continuous concentric eccentric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 5 May 2020 (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.
26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (NMG) the break was passive.
Detailed description
Objective: Τo investigate the effects of massage in athletic performance when applied during intervals of an intense isokinetic exercise protocol for knee extensor muscles.
Design: Randomized Controlled Trial. Participants: 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (CG) the break was passive.
Main Outcome Measures: knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (ME) a sport massage was applied between the sets while in the control group (NME) the break was passive. knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
| Arm | Type | Receives |
|---|---|---|
| Massage group (ME) | Experimental | Other: Isokinetic intense exercise protocol, Other: Massage treatmentA sport massage was applied between the sets of an intense isokinetic exercise protocol for knee extensor muscles |
| Control | Active comparator | Other: Isokinetic intense exercise protocolthe break between the sets of an intense isokinetic exercise protocol for knee extensor muscles was passive |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Professional athletes
- Age range between 18-25.
Key exclusion criteria (3 listed)
- Conduction of any strengthening exercises on the day before the tests
- Musculoskeletal injury during the last six months
- Background of knee trauma and/or surgery
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 |
|---|---|---|
| Isokinetic intense exercise protocolThe isokinetic protocol included 6 sets of 10 maximum efforts at 60 °/s of one leg with a 2-minute break between the sets. | Other | Control, Massage group (ME) |
| Massage treatmentMassage consisted of stroking (30") and petrissage (50") for muscle relaxation, then friction (10"), pincement and clapping (30") to prepare muscles for the next set. | Other | Massage group (ME) |
Primary outcome
Changes in Active Knee Range of Motion (ROM)
Time frame: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
The ROM of knee flexion and extension was measured before and after the exercise program application in both trials. In particular, the active knee extension was measured in the supine position and the active flexion in the prone position using a universal type goniometer.
Changes in creatine kinase (CK) levels in blood plasma
Time frame: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
Blood samples were taken before and 24 hours after the isokinetic protocol to determine whether the exercise program caused fatigue and muscle damage. The blood sample was analyzed to determine CK activity levels in blood plasma using an in-vitro quantitative assay followed by a photometer
Changes in thigh circumference
Time frame: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment
The circumference of the thigh was measured with a tape measure before the test and after the exercise program at fixed spots at a distance of 10 and 20 cm from the center of the patella
Changes in Delayed Onset Muscle Soreness (DOMS)
Time frame: day 1: 24, 48, 72 and 96 hours after-exercise, day 10: 24, 48, 72 and 96 hours after-exercise
The DOMS measurement for the lower extremities (L-DOMS) was performed with the VAS scale 24, 48, 72 and 96 hours after the completion of the program. The VAS scale was tentative where 1 corresponded to "no soreness" and 10 to "very, very sore". The L-DOMS was assessed according to Doma et al1,22 and according to Jakeman et al, through questioning after they completed a body weight squat until their knees were flexed to approximately 90°
1 secondary outcome
Changes in concentric and eccentric torque
Time frame: day 1: pre-treatment
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 9 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Evaggelos Sykaras study director
Department of Physical Education and Sports Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic intense exercise protocol and Massage treatment in people with Athletic Performance, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 9 Jul 2020. 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 Greece. 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. 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?
Changes in Active Knee Range of Motion (ROM) (time frame: day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2020.