FlexibilityNCT04328155
Effects of Different Electrophysical Agents in Hamstring Muscles Flexibility of Healthy Individuals
A study testing Hotpack Group, Infrared Group and Ultrasound Group in people with Flexibility and Hamstring Muscles, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Sixty healthy individuals will be randomised into four groups. Group I (15 subjects) will be applied hotpacks, Group II (15 subjects) will be applied infrared, Group III will be applied ultrasound to hamstring muscles for 18 sessions 3 times per week and the subjects will do hamstring self stretching exercise 3 times… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexibility, Hamstring Muscles
- What is being tested?
- Hotpack Group, Infrared Group and Ultrasound Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2019to 28 Aug 2021
- 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
- Being Student in Saraykoy Vocational School
- Having Active Knee Extension degree lower than 60
Who cannot join
- undergoing surgical operation for knee pathologies
- history of trauma involving knee joint region
- having a systemic and inflammatory disease targeting this region
- pregnancy
- malignancy
- doing another exercise programme
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sarayköy Vocational School
Denizli, 20300
Ayşe Nur OYMAK SOYSAL, Dr., +9005058446603, aysenuroymak@gmail.com
Şule ŞİMŞEK, Dr., +9005058099914, suleserefsimsek@yahoo.com
About this study
Official title: The Effectiveness of Different Electrophysical Agents on Hamstring Muscles Flexibility in Healthy Individuals
Sixty healthy individuals will be randomised into four groups. Group I (15 subjects) will be applied hotpacks, Group II (15 subjects) will be applied infrared, Group III will be applied ultrasound to hamstring muscles for 18 sessions 3 times per week and the subjects will do hamstring self stretching exercise 3 times for 15 seconds. Group IV will only do self stretching exercises.
Outcome measures are Range of Motion and hamstring flexibility. Measurements will record before and after the end of the treatment.
Read the detailed description
Inclusion criteria for the study are; being student of Saraykoy Vocational School, Active knee extension degree must be lower than 60 when the hip flexed to 90 degree. Exclusion criteria are; undergoingsurgery for knee pathologies, having a systemic and inflammatory disease targeting this region, having a knee disorder, pregnancy, malignancy, doing regularly another exercise programme. According to our criteria 60 participants will be randomised into four groups. Group 1 will receive 20 minutes hotpacks and will do hamstring self stretching exercise 3 times for 15 seconds. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching. Group II will receive 20 minutes infrared at prone position and will do self stretching exercise 3 times for 15 seconds. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching.
Group III will receive 5 minutes 1MHz ultrasound therapy and will do self stretching exercise for 18 sessions 3 times per week. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching 3 times for 15 seconds. Group IV will do only hamstring self stretching exercise therapy for 18 sessions 3 times per week. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching 3 times for 15 seconds. Outcome measures are Range of Motion and hamstring flexibility. Range of Motion will be assed by using universal goniometer for knee and hip joints. Hamstring flexibility will be assed with active knee extension test by using universal goniometer. All measurements will done 3 times and average of scores will be taken. Outcomes will be recorded before and after the end of the treatment. All assessments were made by the same researcher before and after treatment.
- Conditions
- Flexibility, Hamstring Muscles
- Being tested
- Hotpack Group, Infrared Group, Ultrasound Group, Control
- Keywords
- electrophysical agents, stretching exercises, hamstring muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hotpack GroupProcedure or surgery
Hotpack Group received 20 minutes hotpack to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
Infrared GroupProcedure or surgery
Infrared Group received 20 minutes infrared to hamstring muscles region at prone position and participants stretchted the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15. seconds .
Ultrasound GroupProcedure or surgery
Ultrasound Group received 5 minutes 1 M-Hz, 1,5 watt/cm2 ultrasound therapy to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
ControlProcedure or surgery
Control Group participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
| Study group | Role | What they receive |
|---|---|---|
| Hotpack Group | Experimental | Group I (15 subjects) received 18 sessions hotpack to hamstring muscles and self stretching exercise3 times per week. Receives: Procedure: Hotpack Group |
| Infrared Group | Experimental | Group II (15 subjects) received 18 sessions infrared to hamstring muscles and self stretching exercise3 times per week. Receives: Procedure: Infrared Group |
| Ultrasound Group | Experimental | Group III (15 subjects) received 18 sessions ultrasound to hamstring muscles and self stretching exercise 3 times per week. Receives: Procedure: Ultrasound Group |
| Control | Active comparator | Group IV (15 subjects) received 18 sessions self stretching exercise 3 times per week. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of ROM
Range of motion was measured by universal goniometer. Knee flexion and extension, Hip flexion, extension, external and internal rotation was measured
Measured: baseline, after 6 weeks
Hamstring Flexibility
Hamstring Flexibility was measured by universal goniometer by using active knee extension test.
Measured: baseline, after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start22 Apr 2019
- Primary completion25 Apr 2020
- Study completion28 Aug 2021 (estimated)
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 FlexibilityStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assingment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nur OYMAK SOYSAL, Pamukkale University
- Investigators
- Atiye KAŞ ÖZDEMİR, Msc, Study chair, Sarayköy Vocational School Turan Mah. Jeotermal Sok. No:1 Sarayköy, DenizliUmmuhan BAŞ ASLAN, Prof .Dr., Study chair, Pamukkale Univercity 20070 Kınıklı Denizli, TurkeyMerve Bergin KORKMAZ, DR., Study chair, Denizli State Hospital 20040 Denizli, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328155
- Sponsor's protocol ID
- 26.06.2018/13
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because there is no web site to share my data
Publications
Sadler SG, Spink MJ, Ho A, De Jonge XJ, Chuter VH. Restriction in lateral bending range of motion, lumbar lordosis, and hamstring flexibility predicts the development of low back pain: a systematic review of prospective cohort studies. BMC Musculoskelet Disord. 2017 May 5;18(1):179. doi: 10.1186/s12891-017-1534-0.
PubMed 28476110Burke 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 16558418
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Different Electrophysical Agents on Hamstring Muscles Flexibility in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04328155
- Acronym / sponsor ID
- 26.06.2018/13
- Conditions
- Flexibility, Hamstring Muscles
- Keywords
- electrophysical agents, stretching exercises, hamstring muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 28 Aug 2021 (estimated)
- First posted
- 31 Mar 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.
Sixty healthy individuals will be randomised into four groups. Group I (15 subjects) will be applied hotpacks, Group II (15 subjects) will be applied infrared, Group III will be applied ultrasound to hamstring muscles for 18 sessions 3 times per week and the subjects will do hamstring self stretching exercise 3 times for 15 seconds. Group IV will only do self stretching exercises.
Outcome measures are Range of Motion and hamstring flexibility. Measurements will record before and after the end of the treatment.
Detailed description
Inclusion criteria for the study are; being student of Saraykoy Vocational School, Active knee extension degree must be lower than 60 when the hip flexed to 90 degree. Exclusion criteria are; undergoingsurgery for knee pathologies, having a systemic and inflammatory disease targeting this region, having a knee disorder, pregnancy, malignancy, doing regularly another exercise programme. According to our criteria 60 participants will be randomised into four groups. Group 1 will receive 20 minutes hotpacks and will do hamstring self stretching exercise 3 times for 15 seconds. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching. Group II will receive 20 minutes infrared at prone position and will do self stretching exercise 3 times for 15 seconds. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching.
Group III will receive 5 minutes 1MHz ultrasound therapy and will do self stretching exercise for 18 sessions 3 times per week. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching 3 times for 15 seconds. Group IV will do only hamstring self stretching exercise therapy for 18 sessions 3 times per week. Participants will do self stretching hamstring exercise at supine position lying and they will use a band for stretching 3 times for 15 seconds. Outcome measures are Range of Motion and hamstring flexibility. Range of Motion will be assed by using universal goniometer for knee and hip joints. Hamstring flexibility will be assed with active knee extension test by using universal goniometer. All measurements will done 3 times and average of scores will be taken. Outcomes will be recorded before and after the end of the treatment. All assessments were made by the same researcher before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- parallel assingment
| Arm | Type | Receives |
|---|---|---|
| Hotpack Group | Experimental | Procedure: Hotpack GroupGroup I (15 subjects) received 18 sessions hotpack to hamstring muscles and self stretching exercise3 times per week. |
| Infrared Group | Experimental | Procedure: Infrared GroupGroup II (15 subjects) received 18 sessions infrared to hamstring muscles and self stretching exercise3 times per week. |
| Ultrasound Group | Experimental | Procedure: Ultrasound GroupGroup III (15 subjects) received 18 sessions ultrasound to hamstring muscles and self stretching exercise 3 times per week. |
| Control | Active comparator | Procedure: ControlGroup IV (15 subjects) received 18 sessions self stretching exercise 3 times per week. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being Student in Saraykoy Vocational School
- Having Active Knee Extension degree lower than 60
Key exclusion criteria (6 listed)
- undergoing surgical operation for knee pathologies
- history of trauma involving knee joint region
- having a systemic and inflammatory disease targeting this region
- pregnancy
- malignancy
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 |
|---|---|---|
| Hotpack GroupHotpack Group received 20 minutes hotpack to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds . | Procedure or surgery | Hotpack Group |
| Infrared GroupInfrared Group received 20 minutes infrared to hamstring muscles region at prone position and participants stretchted the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15. seconds . | Procedure or surgery | Infrared Group |
| Ultrasound GroupUltrasound Group received 5 minutes 1 M-Hz, 1,5 watt/cm2 ultrasound therapy to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds . | Procedure or surgery | Ultrasound Group |
| ControlControl Group participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds . | Procedure or surgery | Control |
Primary outcome
Changes of ROM
Time frame: baseline, after 6 weeks
Range of motion was measured by universal goniometer. Knee flexion and extension, Hip flexion, extension, external and internal rotation was measured
Hamstring Flexibility
Time frame: baseline, after 6 weeks
Hamstring Flexibility was measured by universal goniometer by using active knee extension test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Results publication: PubMed 28476110Sadler SG, Spink MJ, Ho A, De Jonge XJ, Chuter VH. Restriction in lateral bending range of motion, lumbar lordosis, and hamstring flexibility predicts the development of low back pain: a systematic review of prospective cohort studies. BMC Musculoskelet Disord. 2017 May 5;18(1):179. doi: 10.1186/s12891-017-1534-0.
- 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.
- Individual participant dataSharing planned: No. Because there is no web site to share my data
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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.
Atiye KAŞ ÖZDEMİR, Msc study chair
Sarayköy Vocational School Turan Mah. Jeotermal Sok. No:1 Sarayköy, Denizli
Ummuhan BAŞ ASLAN, Prof .Dr. study chair
Pamukkale Univercity 20070 Kınıklı Denizli, Turkey
Merve Bergin KORKMAZ, DR. study chair
Denizli State Hospital 20040 Denizli, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hotpack Group, Infrared Group and Ultrasound Group in people with Flexibility and Hamstring Muscles, run by Pamukkale 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 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Nur OYMAK SOYSAL, Dr. (+9005058446603, aysenuroymak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of ROM (time frame: baseline, after 6 weeks). The study lists 2 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 NCT04328155, 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 10 Mar 2021.