Physical and Rehabilitation MedicineNCT04441801
Optimal Duration of Stretching of the Hamstring Muscle Group
A study testing stretching exercise in people with Physical and Rehabilitation Medicine, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM. DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to… Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical and Rehabilitation Medicine
- What is being tested?
- stretching exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 Jun 2020to 20 Sep 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine.
Who cannot join
- Using of medical aids.
- suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
- had undergone recent surgery (within the past 12 months).
- Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Ibrahim Moustafa
Sharjah city, United Arab Emirate, 27272
About this study
Official title: Optimal Duration of Stretching of the Hamstring Muscle Group : A Randomized Controlled Trial
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures were assessed immediately after the treatment session and 24 hours after the treatment session.
Read the detailed description
A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection.
Inclusion Criteria Subjects who demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects will also be screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position Exclusion Criteria Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.
- Conditions
- Physical and Rehabilitation Medicine
- Being tested
- stretching exercise
- Keywords
- Stretching, Randomized controlled trial, Hamstring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stretching exerciseOther
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position
| Study group | Role | What they receive |
|---|---|---|
| 15 seconds | Experimental | Stretching of the hamstring muscles will be performed by the primary researcher. A straight-leg-raising technique will be used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible, each subject's knee will be maintained in extension with the ankle at 90 degrees without medial (internal) or lateral (external) rotation of the lower extremity, and the extremity was raised until the subject reported discomfort. The subject was asked to relax the lower extremity in an effort to prevent contracting muscles from affecting the stretch and to allow for a slow stretch. stretching will continue for 15 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. Receives: Other: stretching exercise |
| 30 seconds | Experimental | the same stretching technique will continue for 30 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. Receives: Other: stretching exercise |
| 60 seconds | Experimental | the same stretching technique will continue for 60 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. Receives: Other: stretching exercise |
| control | Sham comparator | The control group followed the same procedures except that no stretching force was applied at the end. Receives: Other: stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dermatomal somatosensory evoked potentials immediately after treatment
In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of L3,L4,L5, S1 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.
Measured: pre-treatment , immediately after treatment and at 24 hours after the treatment .
Secondary outcomes (1)
change in range of motion
Each subject will then be measured for knee extension ROM . Measurement of knee extension ROM was made with the subject lying supine with the opposite lower extremity extended and the lower extremity being measured positioned at 90 degrees of hip flexion. The greater trochanter and the lateral epicondyle of the femur and lateral malleolus will be palpated and served as landmarks during measurement, The measurement recorded will be the angle between the leg position and full knee extension (considered to be 0°). Because knee joint contractures will be ruled out, the measurement of knee extension ROM was considered to be an indirect measure of hamstring muscle flexibility, with hamstring muscle tightness being the purported cause of a lack of knee extension ROM.
Measured: pre-treatment , immediately after treatment and at 24 hours after the treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start5 Jun 2020
- Primary completion1 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical and Rehabilitation MedicineStudies 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
- Parallel groups
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 3 intervention groups .The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
- Investigators
- Ibrahim Moustafa, professor, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441801
- Sponsor's protocol ID
- USharjah
- Status last verified
- Oct 2020
- First submitted
- 12 Jun 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Stretching of the Hamstring Muscle Group : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04441801
- Acronym / sponsor ID
- USharjah
- Conditions
- Physical and Rehabilitation Medicine
- Keywords
- Stretching, Randomized controlled trial, Hamstring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 22 Jun 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.
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 168 participants diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures were assessed immediately after the treatment session and 24 hours after the treatment session.
Detailed description
A prospective, blinded, parallel-group, randomized clinical trial will be conducted in the research laboratory of our university. The patients will participate in the study after signing an informed consent form prior to data collection.
Inclusion Criteria Subjects who demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects will also be screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position Exclusion Criteria Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Participants will be divided into four groups according to the stretching duration time (15, 30, and 60s, and the fourth group, which served as a control, did not stretch). The patients will randomly assigned to one of the four groups as follows. The randomization process will be based on permuted blocks of variable sizes. Each random permuted block, created randomly by a number generator, will be transferred to a sequence of consecutively numbered, opaque, sealed envelopes that will be kept in a locked drawer until needed. Once a subject was formally included in the trial, the next envelope in the sequence was opened by the researcher in the presence of the subject who would be assigned to a group according to the number found in the envelope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 3 intervention groups .The three experimental groups was stretched for 15, 30, and 60 seconds, respectively the control group did not stretch
| Arm | Type | Receives |
|---|---|---|
| 15 seconds | Experimental | Other: stretching exerciseStretching of the hamstring muscles will be performed by the primary researcher. A straight-leg-raising technique will be used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible, each subject's knee will be maintained in extension with the ankle at 90 degrees without medial (internal) or lateral (external) rotation of the lower extremity, and the extremity was raised until the subject reported discomfort. The subject was asked to relax the lower extremity in an effort to prevent contracting muscles from affecting the stretch and to allow for a slow stretch. stretching will continue for 15 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. |
| 30 seconds | Experimental | Other: stretching exercisethe same stretching technique will continue for 30 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. |
| 60 seconds | Experimental | Other: stretching exercisethe same stretching technique will continue for 60 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times. |
| control | Sham comparator | Other: stretching exerciseThe control group followed the same procedures except that no stretching force was applied at the end. |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine.
Key exclusion criteria (4 listed)
- Using of medical aids.
- suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions,
- had undergone recent surgery (within the past 12 months).
- Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
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 |
|---|---|---|
| stretching exerciseStatic stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position | Other | 15 seconds, 30 seconds, 60 seconds, control |
Primary outcome
Change in dermatomal somatosensory evoked potentials immediately after treatment
Time frame: pre-treatment , immediately after treatment and at 24 hours after the treatment .
In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of L3,L4,L5, S1 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.
1 secondary outcome
change in range of motion
Time frame: pre-treatment , immediately after treatment and at 24 hours after the 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 30 Oct 2020.
- Individual participant dataSharing planned: No. no plan to make individual participant data (IPD) available to other researchers.
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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.
Ibrahim Moustafa, professor principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stretching exercise in people with Physical and Rehabilitation Medicine, run by University of Sharjah at 1 site in United Arab Emirates.
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 4 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 30 Oct 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 United Arab Emirates. 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. Some participants in this study may receive a placebo. 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 in dermatomal somatosensory evoked potentials immediately after treatment (time frame: pre-treatment , immediately after treatment and at 24 hours after the treatment .). 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 30 Oct 2020.