Muscle SorenessNCT06112899
The Effects of Swedish Massage and Manual Lymph Drainage on Muscle Fatigue
A study testing Nordic Hamstring Exercise in people with Muscle Soreness, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
12 healthy men aged 18-30 will be included in the study. Participants will be selected from students who regularly train and do active sports at the Faculty of Sports Sciences. All participants will do nordic hamstring exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Nordic Hamstring Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2023to 10 Feb 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being male between the ages of 18-30
- Doing sports and training regularly
- Not exercising until 1 week before the study
Who cannot join
- Having a previous lower extremity injury
- Having a neurological problem that prevents exercise
- Does not have a diagnosed cardiovascular problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Kütahya, 43100
About this study
Official title: The Effects of Swedish Massage and Manual Lymph Drainage After Muscle Fatigue in Healthy Young Men
12 healthy men aged 18-30 will be included in the study. Participants will be selected from students who regularly train and do active sports at the Faculty of Sports Sciences. All participants will do nordic hamstring exercise. Participants will rest for 20 minutes after the Nordic hamstring exercise protocol in the first week. In the second week, manual lymph drainage covering the lower extremities will be applied for 20 minutes after exercise. In the third week, a Swedish massage covering the lower extremities will be applied after exercise. The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. The evaluations of the participants will be repeated 3 times: just before the test, after the test and after the application.
- Conditions
- Muscle Soreness
- Being tested
- Nordic Hamstring Exercise
- Keywords
- Manual lympatic Drainage, Swedish Massage, Muscle Soreness
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic Hamstring ExerciseBehavioural
The NHE, also referred to as the nordic curl, is designed to improve eccentric strength of the hamstring muscles. Individuals start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the individual's feet are in contact with the ground throughout the exercise by applying pressure to the player's heels/lower legs. The individual then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase.The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Young Men | Experimental | Not described Receives: Behavioral: Nordic Hamstring Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic Acid Level
Blood lactate levels will be measured using a portable lactic acid analyzer (Lactate Scout+, SensLab GmbH, Leipzig, Germany), which can measure electroenzymatically in approximately 15 seconds from a drop of capillary blood sample taken from the fingertip. Blood samples will be taken using a lancet gun (Vital Plus, China). Before the evaluation, the patient's fingertip will be wiped with alcohol cotton and allowed to dry. Before all measurements, the analyzer will be calibrated with control solutions of known concentration according to the manufacturer's instructions.
Measured: through study completion, an average of 1 year
Gait and Balance
Participants' walking parameters will be measured and recorded instantly with the Zebris™ FDM-2 device. The data obtained from the device will be recorded and compiled into a report via Zebris software installed on the computer. Participants will be asked to walk at least 8 steps on the walking platform at a pace they feel comfortable with. Step length, step width, number of steps per minute (cadence), walking speed (m/s), symmetry of center of pressure changes during walking (length of walking line, length of contact line of each step), maximum power on the feet during walking (N/cm2). ). Participants will be asked to stand with their arms hanging at their sides and their eyes fixed on a point 3 meters away in front of them, maintaining their posture as much as possible for 60 seconds. The changes in the center of pressure (ellipse area (mm2)), the total load on the right and left feet, and the anteroposterior foot distribution will be obtained.
Measured: through study completion, an average of 1 year
Jumping Performance
Jumping performance will be evaluated with the OptoJump (Microgate, Italy) device. Using the system software, a profile will be created for each participant and BFS Vertical Jump, acoustic reaction and stiffness will be selected from the test protocols in the system.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start26 Oct 2023
- Primary completion31 Dec 2023
- Study completion10 Feb 2024
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 SorenessStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hümeyra Kiloatar, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112899
- Sponsor's protocol ID
- 2023/02-02
- Status last verified
- Feb 2024
- First submitted
- 23 Oct 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendiguchia J, Arcos AL, Garrues MA, Myer GD, Yanci J, Idoate F. The use of MRI to evaluate posterior thigh muscle activity and damage during nordic hamstring exercise. J Strength Cond Res. 2013 Dec;27(12):3426-35. doi: 10.1519/JSC.0b013e31828fd3e7.
PubMed 23524362Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.
PubMed 26744335Cairns SP. Lactic acid and exercise performance : culprit or friend? Sports Med. 2006;36(4):279-91. doi: 10.2165/00007256-200636040-00001.
PubMed 16573355
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Swedish Massage and Manual Lymph Drainage After Muscle Fatigue in Healthy Young Men
- ClinicalTrials.gov ID
- NCT06112899
- Acronym / sponsor ID
- 2023/02-02
- Conditions
- Muscle Soreness
- Keywords
- Manual lympatic Drainage, Swedish Massage, Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 2 Nov 2023 (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.
12 healthy men aged 18-30 will be included in the study. Participants will be selected from students who regularly train and do active sports at the Faculty of Sports Sciences. All participants will do nordic hamstring exercise. Participants will rest for 20 minutes after the Nordic hamstring exercise protocol in the first week. In the second week, manual lymph drainage covering the lower extremities will be applied for 20 minutes after exercise. In the third week, a Swedish massage covering the lower extremities will be applied after exercise. The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. The evaluations of the participants will be repeated 3 times: just before the test, after the test and after the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Young Men | Experimental | Behavioral: Nordic Hamstring Exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being male between the ages of 18-30
- Doing sports and training regularly
- Not exercising until 1 week before the study
Key exclusion criteria (3 listed)
- Having a previous lower extremity injury
- Having a neurological problem that prevents exercise
- Does not have a diagnosed cardiovascular problem
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 |
|---|---|---|
| Nordic Hamstring ExerciseThe NHE, also referred to as the nordic curl, is designed to improve eccentric strength of the hamstring muscles. Individuals start in a kneeling position, with the torso from the knees upward held rigid and straight. The training partner ensures that the individual's feet are in contact with the ground throughout the exercise by applying pressure to the player's heels/lower legs. The individual then lowers his upper body to the ground, as slowly as possible to maximize loading in the eccentric phase. Hands and arms are used to break his forward fall and to push him back up after the chest has touched the ground, to minimize loading in the concentric phase.The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. | Behavioural | Healthy Young Men |
Primary outcome
Lactic Acid Level
Time frame: through study completion, an average of 1 year
Blood lactate levels will be measured using a portable lactic acid analyzer (Lactate Scout+, SensLab GmbH, Leipzig, Germany), which can measure electroenzymatically in approximately 15 seconds from a drop of capillary blood sample taken from the fingertip. Blood samples will be taken using a lancet gun (Vital Plus, China). Before the evaluation, the patient's fingertip will be wiped with alcohol cotton and allowed to dry. Before all measurements, the analyzer will be calibrated with control solutions of known concentration according to the manufacturer's instructions.
Gait and Balance
Time frame: through study completion, an average of 1 year
Participants' walking parameters will be measured and recorded instantly with the Zebris™ FDM-2 device. The data obtained from the device will be recorded and compiled into a report via Zebris software installed on the computer. Participants will be asked to walk at least 8 steps on the walking platform at a pace they feel comfortable with. Step length, step width, number of steps per minute (cadence), walking speed (m/s), symmetry of center of pressure changes during walking (length of walking line, length of contact line of each step), maximum power on the feet during walking (N/cm2). ). Participants will be asked to stand with their arms hanging at their sides and their eyes fixed on a point 3 meters away in front of them, maintaining their posture as much as possible for 60 seconds. The changes in the center of pressure (ellipse area (mm2)), the total load on the right and left feet, and the anteroposterior foot distribution will be obtained.
Jumping Performance
Time frame: through study completion, an average of 1 year
Jumping performance will be evaluated with the OptoJump (Microgate, Italy) device. Using the system software, a profile will be created for each participant and BFS Vertical Jump, acoustic reaction and stiffness will be selected from the test protocols in the system.
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 13 Feb 2024.
- Background: PubMed 23524362Mendiguchia J, Arcos AL, Garrues MA, Myer GD, Yanci J, Idoate F. The use of MRI to evaluate posterior thigh muscle activity and damage during nordic hamstring exercise. J Strength Cond Res. 2013 Dec;27(12):3426-35. doi: 10.1519/JSC.0b013e31828fd3e7.
- Background: PubMed 26744335Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.
- Background: PubMed 16573355Cairns SP. Lactic acid and exercise performance : culprit or friend? Sports Med. 2006;36(4):279-91. doi: 10.2165/00007256-200636040-00001.
- 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.
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 Nordic Hamstring Exercise in people with Muscle Soreness, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 3 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 13 Feb 2024. 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 Turkey (Türkiye). 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?
Lactic Acid Level (time frame: through study completion, an average of 1 year). 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 NCT06112899, 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 13 Feb 2024.