Sports Physical TherapyNCT03884738

Strengthening Effect on Hamstring's Passive Mechanical Properties

A study testing Concentric Exercise, Nordic Eccentric exercise and Neuromuscular Electrical Stimulation in people with Sports Physical Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Sports Physical Therapy
What is being tested?: Concentric Exercise, Nordic Eccentric exercise and Neuromuscular Electrical Stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 21 Mar 2019to 1 Dec 2019
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 sedentary

Who cannot join

Having knee, hip and/or back pain
Having a cardiovascular condition/disease
History of previous knee and/or hip surgery
Having a diagnose of any systemic disease
History of previous hamstring injury
Being physically active within last year ( Regular activity at least 3 days a week and continuity of at least 2 months was accepted as being physically active)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hacettepe University
Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Effects Of Different Strengthening Methods On Hamstring Muscle Group's Passive Mechanical Properties in Healthy Individuals

The purpose of this study was to investigate effects of different strengthening methods on hamstring muscle group's passive mechanical properties and to investigate this effect's relation with performance changes in healthy individuals. 42 healthy sedentary male participated in this study. Passive mechanical properties and strength of hamstring and quadriceps muscles, flexibility of hamstring muscles, anaerobic explosive strength, reaction time, agility were measured. Participants randomized evenly into one of three groups; eccentric, concentric and neuromuscular electrical stimulation (NMES). After 8 weeks training period, participants were measured again.

Conditions: Sports Physical Therapy
Being tested: Concentric Exercise, Nordic Eccentric exercise, Neuromuscular Electrical Stimulation
Keywords: Muscle Tonus, Elasticity, Electric Stimulation Therapy, Physical Conditioning, Human
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Concentric ExerciseOther
Leg Curl Machine: 1st week - 1st day is 10 maximum repeat test. 2nd week - 2 days of training - 2 sets of 6 repeats. %60 percent of maximum load.
3rd week - 3 days of training - 3 sets of 6-8 repeats. %60-80 of maximum load. 4th-8th week - 3 days of training - 3 sets of 8-12 repeats. when 3 sets of 12 achieved, load was increased with 2.5kg.
Nordic Eccentric exerciseOther
1. st week - 1 day - 2 sets of 5 repeats.
2. nd week - 2 days - 2 sets of 6 repeats.
3. rd week - 3 days - 3 sets of 6-8 repeats.
4. th week - 3 days - 3 sets of 8-10 repeats. 5-8th weeks - 3 days - 3 sets of 12-8 repeats. When achieved 3 sets of 12 repeats with full range, speed was increased.
Neuromuscular Electrical StimulationOther
8 weeks, three times per week, 15 minutes of bilateral hamstring stimulation. 100 Hz. frequency, 600 microsecond duration rectangular current

Study groups in NCT03884738
Study group	Role	What they receive
Concentric	Active comparator	Leg Curl Training Receives: Other: Concentric Exercise
Eccentric	Active comparator	Nordic Hamstring Training Receives: Other: Nordic Eccentric exercise
Neuromuscular Electrical Stimulation	Active comparator	Stimulation Training Receives: Other: Neuromuscular Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Passive Mechanical Properties
Tone, Elasticity and Stiffness evaluation. Evaluated with Myotonometer-3
Measured: Change from baseline passive mechanical properties at 8 weeks

Secondary outcomes (5)

Flexibility Measurement
Sit and reach test was used for hamstring flexibility
Measured: Change from baseline flexibility at 8 weeks
Muscle Strength Measurement
Hamstring and Quadriceps strength were measured with LaFayette Manuel Muscle Tester
Measured: Change from baseline muscle strength at 8 weeks
Agility Measurement
Illinois Agility Test was used for agility measurement
Measured: Change from baseline agility time at 8 weeks
Anaerobic Explosive Power
Jump and Reach test was administered
Measured: Change from baseline anaerobic explosive power at 8 weeks
Reaction Time
ruler drop test was used for reaction timing
Measured: Change from baseline reaction time at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 20191 Dec 2019

First posted21 Mar 2019
Study start21 Mar 2019
Primary completion1 Dec 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Sports Physical TherapyStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomization into three groups and measurement before and after intervention
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03884738
Sponsor's protocol ID: HacettepeSportsPhysio
Status last verified: Apr 2020
First submitted: 18 Mar 2019
Last updated: 22 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ayala F, Sainz de Baranda P, De Ste Croix M, Santonja F. Reproducibility and criterion-related validity of the sit and reach test and toe touch test for estimating hamstring flexibility in recreationally active young adults. Phys Ther Sport. 2012 Nov;13(4):219-26. doi: 10.1016/j.ptsp.2011.11.001. Epub 2012 Jan 23.
PubMed 23068896
Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
PubMed 26509265
Amiri-Khorasani M, Sahebozamani M, Tabrizi KG, Yusof AB. Acute effect of different stretching methods on Illinois agility test in soccer players. J Strength Cond Res. 2010 Oct;24(10):2698-704. doi: 10.1519/JSC.0b013e3181bf049c.
PubMed 20168255
Schwesig R, Koke A, Fischer D, Fieseler G, Jungermann P, Delank KS, Hermassi S. Validity and Reliability of the New Handball-Specific Complex Test. J Strength Cond Res. 2016 Feb;30(2):476-86. doi: 10.1519/JSC.0000000000001061.
PubMed 26815176
Mjolsnes R, Arnason A, Osthagen T, Raastad T, Bahr R. A 10-week randomized trial comparing eccentric vs. concentric hamstring strength training in well-trained soccer players. Scand J Med Sci Sports. 2004 Oct;14(5):311-7. doi: 10.1046/j.1600-0838.2003.367.x.
PubMed 15387805
Glaviano NR, Langston WT, Hart JM, Saliba S. Influence of patterned electrical neuromuscular stimulation on quadriceps activation in individuals with knee joint injury. Int J Sports Phys Ther. 2014 Dec;9(7):915-23.
PubMed 25540707

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects Of Different Strengthening Methods On Hamstring Muscle Group's Passive Mechanical Properties in Healthy Individuals
ClinicalTrials.gov ID: NCT03884738
Acronym / sponsor ID: HacettepeSportsPhysio
Conditions: Sports Physical Therapy
Keywords: Muscle Tonus, Elasticity, Electric Stimulation Therapy, Physical Conditioning, Human
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Study start: 21 Mar 2019 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 21 Mar 2019 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: randomization into three groups and measurement before and after intervention

Arm	Type	Receives
Concentric	Active comparator	Other: Concentric ExerciseLeg Curl Training
Eccentric	Active comparator	Other: Nordic Eccentric exerciseNordic Hamstring Training
Neuromuscular Electrical Stimulation	Active comparator	Other: Neuromuscular Electrical StimulationStimulation Training

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

being sedentary

Key exclusion criteria (6 listed)

Having knee, hip and/or back pain
Having a cardiovascular condition/disease
History of previous knee and/or hip surgery
Having a diagnose of any systemic disease
History of previous hamstring injury

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
Concentric ExerciseLeg Curl Machine: 1st week - 1st day is 10 maximum repeat test. 2nd week - 2 days of training - 2 sets of 6 repeats. %60 percent of maximum load. 3rd week - 3 days of training - 3 sets of 6-8 repeats. %60-80 of maximum load. 4th-8th week - 3 days of training - 3 sets of 8-12 repeats. when 3 sets of 12 achieved, load was increased with 2.5kg.	Other	Concentric
Nordic Eccentric exercise1. st week - 1 day - 2 sets of 5 repeats. 2. nd week - 2 days - 2 sets of 6 repeats. 3. rd week - 3 days - 3 sets of 6-8 repeats. 4. th week - 3 days - 3 sets of 8-10 repeats. 5-8th weeks - 3 days - 3 sets of 12-8 repeats. When achieved 3 sets of 12 repeats with full range, speed was increased.	Other	Eccentric
Neuromuscular Electrical Stimulation8 weeks, three times per week, 15 minutes of bilateral hamstring stimulation. 100 Hz. frequency, 600 microsecond duration rectangular current	Other	Neuromuscular Electrical Stimulation

Primary outcome

Passive Mechanical Properties
Time frame: Change from baseline passive mechanical properties at 8 weeks
Tone, Elasticity and Stiffness evaluation. Evaluated with Myotonometer-3

5 secondary outcomes

Flexibility Measurement
Time frame: Change from baseline flexibility at 8 weeks
Muscle Strength Measurement
Time frame: Change from baseline muscle strength at 8 weeks
Agility Measurement
Time frame: Change from baseline agility time at 8 weeks
Anaerobic Explosive Power
Time frame: Change from baseline anaerobic explosive power at 8 weeks
Reaction Time
Time frame: Change from baseline reaction time at 8 weeks

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 22 Apr 2020.
Background: PubMed 23068896Ayala F, Sainz de Baranda P, De Ste Croix M, Santonja F. Reproducibility and criterion-related validity of the sit and reach test and toe touch test for estimating hamstring flexibility in recreationally active young adults. Phys Ther Sport. 2012 Nov;13(4):219-26. doi: 10.1016/j.ptsp.2011.11.001. Epub 2012 Jan 23.
Background: PubMed 26509265Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
Background: PubMed 20168255Amiri-Khorasani M, Sahebozamani M, Tabrizi KG, Yusof AB. Acute effect of different stretching methods on Illinois agility test in soccer players. J Strength Cond Res. 2010 Oct;24(10):2698-704. doi: 10.1519/JSC.0b013e3181bf049c.
Background: PubMed 26815176Schwesig R, Koke A, Fischer D, Fieseler G, Jungermann P, Delank KS, Hermassi S. Validity and Reliability of the New Handball-Specific Complex Test. J Strength Cond Res. 2016 Feb;30(2):476-86. doi: 10.1519/JSC.0000000000001061.
Background: PubMed 15387805Mjolsnes R, Arnason A, Osthagen T, Raastad T, Bahr R. A 10-week randomized trial comparing eccentric vs. concentric hamstring strength training in well-trained soccer players. Scand J Med Sci Sports. 2004 Oct;14(5):311-7. doi: 10.1046/j.1600-0838.2003.367.x.
Background: PubMed 25540707Glaviano NR, Langston WT, Hart JM, Saliba S. Influence of patterned electrical neuromuscular stimulation on quadriceps activation in individuals with knee joint injury. Int J Sports Phys Ther. 2014 Dec;9(7):915-23.
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.

tuzun fırat, Assoc. Prof. study director

Hacettepe University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 6 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 22 Apr 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 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?

Passive Mechanical Properties (time frame: Change from baseline passive mechanical properties at 8 weeks). 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 NCT03884738, which also lists 6 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 22 Apr 2020.