Range of Motion, ArticularNCT03021850
Different Therapeutical Modalities Associated to Hamstring Flexibility Training
A study testing Flexibility training with or without different thermal modalities in people with Range of Motion, Articular, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the acute effect of the use of different thermal modalities associated to the training of passive flexibility of the hamstring muscles in the amplitude of motion of the knee extension. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Range of Motion, Articular
- What is being tested?
- Flexibility training with or without different thermal modalities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2016to 6 Jul 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men with knee extension range less than or equal to 160 degrees.
Who cannot join
- Have exercised in the last 48 hours before the intervention session;
- Previous neurological, muscular or articular disease that influences the performance of the training;
- Anterior lower limb surgery;
- Presence of painful symptoms or edema in the lower limbs;
- Hypersensitivity to ice or heat;
- Raynaud's syndrome;
Show all 19Show fewer
- Loss of local thermal sensitivity;
- Have metallic implants;
- Use of cardiac pacemaker;
- Presence of malignant tumor;
- Arterial diseases;
- Deep venous thrombosis or phlebitis;
- Fever and inflammatory processes;
- Bleeding processes;
- Osteomyelitis;
- Epilepsy;
- Pulmonary and bone tuberculosis;
- Kidney or urinary tract infection;
- Cryoglobulinemia;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Science of Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Comparison Between Different Therapeutical Modalities Associated to Hamstring Flexibility Training: Randomized Clinical Trial
The purpose of this study is to compare the acute effect of the use of different thermal modalities associated to the training of passive flexibility of the hamstring muscles in the amplitude of motion of the knee extension.
Read the detailed description
Context: In the literature there is a disagreement of results and protocols regarding the use of thermal modalities associated with the training of flexibility of the hamstring muscles. Most studies on the subject, used the heat and cryotherapy prior to stretching these. Therefore, the investigators aimed to conduct an experimental study using the therapeutics term concomitant arrangements to passive static stretching these muscles.
Methods: Clinical trial randomized crossover, which will a sample of 42 subjects (healthy young men, aged 20 to 30 years). Were divided into 3 groups (Group 1 passive static stretching hamstrings, Group 2 heat + passive static stretching hamstrings and Group 3 cryotherapy + static stretching hamstrings passive) with 14 subjects each. Where the participants will control themselves, since all carry out the three interventions, only at different times. Each action will be performed every 7 days. Individuals will be subjected to active test of the range of motion of knee extension (goniometer) and hamstring muscle strength (dynamometer).
- Conditions
- Range of Motion, Articular
- Being tested
- Flexibility training with or without different thermal modalities
- Keywords
- Pliability, Cryotherapy, Hot temperature, Hyperthermia, induced, Randomized Controlled Trial, Hamstring muscles, Muscle stretching exercises
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexibility training with or without different thermal modalitiesProcedure or surgery
Flexibility training of the hamstring muscles by passive static stretching of the hamstring muscles in 10 30-second repetitions, with a 10-second pause between each repetition associated with or without short-wave heating or cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Stretching associated with shortwave heating | Active comparator | Applying deep heat through the shortwave equipment for 20 minutes, in coplanar application to the posterior part of the thigh associated with flexibility training of the hamstrings in the last 10 minutes of the session, performed by passive static stretching of the hamstring muscles in 10 repetitions of 30 seconds, with a 10 second pause between each repetition. Receives: Procedure: Flexibility training with or without different thermal modalities |
| Stretching associated with cryotherapy | Active comparator | Cryotherapy application for 20 minutes, applied to the posterior part of the thigh associated with flexibility training of the hamstring muscles in the last 10 minutes of the session, performed by passive static stretching of the hamstring muscles, in 10 repetitions of 30 seconds , with a 10 second pause between each repetition. Receives: Procedure: Flexibility training with or without different thermal modalities |
| Stretching isolated | Other | The flexibility training of the hamstring muscles will be by passive static stretching of the hamstring muscles in 10 repetitions of 30-second , with a 10-second pause between each repetition. Receives: Procedure: Flexibility training with or without different thermal modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Active Knee Extension Test
Active Knee Extension Test is performed in a standardised procedure and is measured in degrees.
Measured: 3 weeks
Secondary outcomes (2)
Change of Peak Torque of flexors and knee extensors
Peak torque of flexors and knee extensors is performed in an isokinetic dynamometer (Biodex system III), in a standardised procedure.
Measured: 3 weeks
Change of Passive Resistance flexors and knee extensors
Passive Resistance of flexors and knee extensors is performed in an isokinetic dynamometer (Biodex system III), in a standardised procedure.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start2 Apr 2016
- Primary completion10 Feb 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Range of Motion, ArticularStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Henrique Telles da Rosa, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021850
- Sponsor's protocol ID
- CAAE 52107115.7.0000.5345
- Status last verified
- Oct 2017
- First submitted
- 6 Jan 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
Publications
Marek SM, Cramer JT, Fincher AL, Massey LL, Dangelmaier SM, Purkayastha S, Fitz KA, Culbertson JY. Acute Effects of Static and Proprioceptive Neuromuscular Facilitation Stretching on Muscle Strength and Power Output. J Athl Train. 2005 Jun;40(2):94-103.
PubMed 15970955Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
PubMed 22319684Bandy WD, Irion JM, Briggler M. The effect of time and frequency of static stretching on flexibility of the hamstring muscles. Phys Ther. 1997 Oct;77(10):1090-6. doi: 10.1093/ptj/77.10.1090.
PubMed 9327823Bleakley CM, Costello JT. Do thermal agents affect range of movement and mechanical properties in soft tissues? A systematic review. Arch Phys Med Rehabil. 2013 Jan;94(1):149-63. doi: 10.1016/j.apmr.2012.07.023. Epub 2012 Aug 7.
PubMed 22885279Burke DG, Holt LE, Rasmussen R, MacKinnon NC, Vossen JF, Pelham TW. Effects of Hot or Cold Water Immersion and Modified Proprioceptive Neuromuscular Facilitation Flexibility Exercise on Hamstring Length. J Athl Train. 2001 Mar;36(1):16-19.
PubMed 12937509Brodowicz GR, Welsh R, Wallis J. Comparison of stretching with ice, stretching with heat, or stretching alone on hamstring flexibility. J Athl Train. 1996 Oct;31(4):324-7.
PubMed 16558418Draper DO, Castro JL, Feland B, Schulthies S, Eggett D. Shortwave diathermy and prolonged stretching increase hamstring flexibility more than prolonged stretching alone. J Orthop Sports Phys Ther. 2004 Jan;34(1):13-20. doi: 10.2519/jospt.2004.34.1.13.
PubMed 14964587Herbert RD, de Noronha M, Kamper SJ. Stretching to prevent or reduce muscle soreness after exercise. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD004577. doi: 10.1002/14651858.CD004577.pub3.
PubMed 21735398Konrad A, Tilp M. Increased range of motion after static stretching is not due to changes in muscle and tendon structures. Clin Biomech (Bristol). 2014 Jun;29(6):636-42. doi: 10.1016/j.clinbiomech.2014.04.013. Epub 2014 May 10.
PubMed 24856792Rosario JL, Foletto A. Comparative study of stretching modalities in healthy women: heating and application time. J Bodyw Mov Ther. 2015 Jan;19(1):3-7. doi: 10.1016/j.jbmt.2013.12.003. Epub 2013 Dec 11.
PubMed 25603738Lim KI, Nam HC, Jung KS. Effects on hamstring muscle extensibility, muscle activity, and balance of different stretching techniques. J Phys Ther Sci. 2014 Feb;26(2):209-13. doi: 10.1589/jpts.26.209. Epub 2014 Feb 28.
PubMed 24648633Goncalves R, Gurjao AL, Jambassi Filho JC, Farinatti Pde T, Gobbi LT, Gobbi S. The acute effects of static stretching on peak force, peak rate of force development and muscle activity during single- and multiple-joint actions in older women. J Sports Sci. 2013;31(7):690-8. doi: 10.1080/02640414.2012.746727. Epub 2012 Dec 12.
PubMed 23234265Umegaki H, Ikezoe T, Nakamura M, Nishishita S, Kobayashi T, Fujita K, Tanaka H, Ichihashi N. Acute effects of static stretching on the hamstrings using shear elastic modulus determined by ultrasound shear wave elastography: Differences in flexibility between hamstring muscle components. Man Ther. 2015 Aug;20(4):610-3. doi: 10.1016/j.math.2015.02.006. Epub 2015 Mar 2.
PubMed 25795108Chen CH, Nosaka K, Chen HL, Lin MJ, Tseng KW, Chen TC. Effects of flexibility training on eccentric exercise-induced muscle damage. Med Sci Sports Exerc. 2011 Mar;43(3):491-500. doi: 10.1249/MSS.0b013e3181f315ad.
PubMed 20689450Nakano J, Yamabayashi C, Scott A, Reid WD. The effect of heat applied with stretch to increase range of motion: a systematic review. Phys Ther Sport. 2012 Aug;13(3):180-8. doi: 10.1016/j.ptsp.2011.11.003. Epub 2011 Dec 29.
PubMed 22814453
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Therapeutical Modalities Associated to Hamstring Flexibility Training: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03021850
- Acronym / sponsor ID
- CAAE 52107115.7.0000.5345
- Conditions
- Range of Motion, Articular
- Keywords
- Pliability, Cryotherapy, Hot temperature, Hyperthermia, induced, Randomized Controlled Trial, Hamstring muscles, Muscle stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 2 Apr 2016 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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.
The purpose of this study is to compare the acute effect of the use of different thermal modalities associated to the training of passive flexibility of the hamstring muscles in the amplitude of motion of the knee extension.
Detailed description
Context: In the literature there is a disagreement of results and protocols regarding the use of thermal modalities associated with the training of flexibility of the hamstring muscles. Most studies on the subject, used the heat and cryotherapy prior to stretching these. Therefore, the investigators aimed to conduct an experimental study using the therapeutics term concomitant arrangements to passive static stretching these muscles.
Methods: Clinical trial randomized crossover, which will a sample of 42 subjects (healthy young men, aged 20 to 30 years). Were divided into 3 groups (Group 1 passive static stretching hamstrings, Group 2 heat + passive static stretching hamstrings and Group 3 cryotherapy + static stretching hamstrings passive) with 14 subjects each. Where the participants will control themselves, since all carry out the three interventions, only at different times. Each action will be performed every 7 days. Individuals will be subjected to active test of the range of motion of knee extension (goniometer) and hamstring muscle strength (dynamometer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stretching associated with shortwave heating | Active comparator | Procedure: Flexibility training with or without different thermal modalitiesApplying deep heat through the shortwave equipment for 20 minutes, in coplanar application to the posterior part of the thigh associated with flexibility training of the hamstrings in the last 10 minutes of the session, performed by passive static stretching of the hamstring muscles in 10 repetitions of 30 seconds, with a 10 second pause between each repetition. |
| Stretching associated with cryotherapy | Active comparator | Procedure: Flexibility training with or without different thermal modalitiesCryotherapy application for 20 minutes, applied to the posterior part of the thigh associated with flexibility training of the hamstring muscles in the last 10 minutes of the session, performed by passive static stretching of the hamstring muscles, in 10 repetitions of 30 seconds , with a 10 second pause between each repetition. |
| Stretching isolated | Other | Procedure: Flexibility training with or without different thermal modalitiesThe flexibility training of the hamstring muscles will be by passive static stretching of the hamstring muscles in 10 repetitions of 30-second , with a 10-second pause between each repetition. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men with knee extension range less than or equal to 160 degrees.
Key exclusion criteria (19 listed)
- Have exercised in the last 48 hours before the intervention session;
- Previous neurological, muscular or articular disease that influences the performance of the training;
- Anterior lower limb surgery;
- Presence of painful symptoms or edema in the lower limbs;
- Hypersensitivity to ice or heat;
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 |
|---|---|---|
| Flexibility training with or without different thermal modalitiesFlexibility training of the hamstring muscles by passive static stretching of the hamstring muscles in 10 30-second repetitions, with a 10-second pause between each repetition associated with or without short-wave heating or cryotherapy | Procedure or surgery | Stretching associated with cryotherapy, Stretching associated with shortwave heating, Stretching isolated |
Primary outcome
Change of Active Knee Extension Test
Time frame: 3 weeks
Active Knee Extension Test is performed in a standardised procedure and is measured in degrees.
2 secondary outcomes
Change of Peak Torque of flexors and knee extensors
Time frame: 3 weeks
Change of Passive Resistance flexors and knee extensors
Time frame: 3 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 18 Oct 2017.
- Results publication: PubMed 15970955Marek SM, Cramer JT, Fincher AL, Massey LL, Dangelmaier SM, Purkayastha S, Fitz KA, Culbertson JY. Acute Effects of Static and Proprioceptive Neuromuscular Facilitation Stretching on Muscle Strength and Power Output. J Athl Train. 2005 Jun;40(2):94-103.
- Results publication: PubMed 22319684Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
- Results publication: PubMed 9327823Bandy WD, Irion JM, Briggler M. The effect of time and frequency of static stretching on flexibility of the hamstring muscles. Phys Ther. 1997 Oct;77(10):1090-6. doi: 10.1093/ptj/77.10.1090.
- Results publication: PubMed 22885279Bleakley CM, Costello JT. Do thermal agents affect range of movement and mechanical properties in soft tissues? A systematic review. Arch Phys Med Rehabil. 2013 Jan;94(1):149-63. doi: 10.1016/j.apmr.2012.07.023. Epub 2012 Aug 7.
- Results publication: PubMed 12937509Burke DG, Holt LE, Rasmussen R, MacKinnon NC, Vossen JF, Pelham TW. Effects of Hot or Cold Water Immersion and Modified Proprioceptive Neuromuscular Facilitation Flexibility Exercise on Hamstring Length. J Athl Train. 2001 Mar;36(1):16-19.
- Results publication: PubMed 16558418Brodowicz GR, Welsh R, Wallis J. Comparison of stretching with ice, stretching with heat, or stretching alone on hamstring flexibility. J Athl Train. 1996 Oct;31(4):324-7.
- Results publication: PubMed 14964587Draper DO, Castro JL, Feland B, Schulthies S, Eggett D. Shortwave diathermy and prolonged stretching increase hamstring flexibility more than prolonged stretching alone. J Orthop Sports Phys Ther. 2004 Jan;34(1):13-20. doi: 10.2519/jospt.2004.34.1.13.
- Results publication: PubMed 21735398Herbert RD, de Noronha M, Kamper SJ. Stretching to prevent or reduce muscle soreness after exercise. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD004577. doi: 10.1002/14651858.CD004577.pub3.
- Results publication: PubMed 24856792Konrad A, Tilp M. Increased range of motion after static stretching is not due to changes in muscle and tendon structures. Clin Biomech (Bristol). 2014 Jun;29(6):636-42. doi: 10.1016/j.clinbiomech.2014.04.013. Epub 2014 May 10.
- Results publication: PubMed 25603738Rosario JL, Foletto A. Comparative study of stretching modalities in healthy women: heating and application time. J Bodyw Mov Ther. 2015 Jan;19(1):3-7. doi: 10.1016/j.jbmt.2013.12.003. Epub 2013 Dec 11.
- Results publication: PubMed 24648633Lim KI, Nam HC, Jung KS. Effects on hamstring muscle extensibility, muscle activity, and balance of different stretching techniques. J Phys Ther Sci. 2014 Feb;26(2):209-13. doi: 10.1589/jpts.26.209. Epub 2014 Feb 28.
- Results publication: PubMed 23234265Goncalves R, Gurjao AL, Jambassi Filho JC, Farinatti Pde T, Gobbi LT, Gobbi S. The acute effects of static stretching on peak force, peak rate of force development and muscle activity during single- and multiple-joint actions in older women. J Sports Sci. 2013;31(7):690-8. doi: 10.1080/02640414.2012.746727. Epub 2012 Dec 12.
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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 Flexibility training with or without different thermal modalities in people with Range of Motion, Articular, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 19 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 18 Oct 2017. 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 Brazil. 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?
Change of Active Knee Extension Test (time frame: 3 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 NCT03021850, which also lists 20 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 18 Oct 2017.