StretchNCT04459832
Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial
A study testing stretch hamstring in people with Stretch, run by Cairo University.
Trial summary
identification of optimal duration for hamstring muscle stretch by using 3 different time of stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4 group one control and 3 experimental groups according to stretch time. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stretch
- What is being tested?
- stretch hamstring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Aug 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects had to 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 were also screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position
Who cannot join
- 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
About this study
Official title: Optimal Time of Hamstring Stretch in Elderly
identification of optimal duration for hamstring muscle stretch by using 3 different time of stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4 group one control and 3 experimental groups according to stretch time.
Read the detailed description
Abstract:
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will participate in the study 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 will stretched 5 times per week for 4 weeks 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 will be assessed immediately after the treatment session and 24 hours after the treatment session.
- Conditions
- Stretch
- Being tested
- stretch hamstring
- 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.
stretch hamstringProcedure or surgery
Stretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was 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
| Study group | Role | What they receive |
|---|---|---|
| 15 second stretch | Experimental | Stretching of the hamstring muscles was performed by the primary researcher for 15 seconds. A straight-leg-raising technique was 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 Receives: Procedure: stretch hamstring |
| 30 second stretch | Experimental | Stretching of the hamstring muscles was performed by the primary researcher for 30 seconds. A straight-leg-raising technique was 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 Receives: Procedure: stretch hamstring |
| 60 second stretch | Experimental | Stretching of the hamstring muscles was performed by the primary researcher for 60 seconds. A straight-leg-raising technique was 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 Receives: Procedure: stretch hamstring |
| control | Sham comparator | The control group followed the same procedures except that no stretching force was applied at the end Receives: Procedure: stretch hamstring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological findings.
Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.
Measured: Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session
Secondary outcomes (1)
ROM
Each subject was then measured for knee extension ROM on both lower extremities
Measured: Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StretchStudies of the same condition, open and under way.
- More trials run by Cairo 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
- randomized controlled trial study 100 participants will be recruited to participate in the study after assigning a conset form, participants will be divided into 4 group ,one control which will not receive stretch of hamstring and 3 experimental groups will recive different duration for hamstring stretch 15,30,60 and DSSEP will be measured as the primary outcome and knee ROM will be measured as a secondary outcomes in order to identify the optimal duration of hamstring stretch
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Abu El Kasem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459832
- Sponsor's protocol ID
- A Randomized Controlled Trial
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time of Hamstring Stretch in Elderly
- ClinicalTrials.gov ID
- NCT04459832
- Acronym / sponsor ID
- A Randomized Controlled Trial
- Conditions
- Stretch
- Keywords
- Stretching, Randomized controlled trial, Hamstring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Jul 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.
identification of optimal duration for hamstring muscle stretch by using 3 different time of stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4 group one control and 3 experimental groups according to stretch time.
Detailed description
Abstract:
OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.
DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will participate in the study 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 will stretched 5 times per week for 4 weeks 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 will be assessed immediately after the treatment session and 24 hours after the treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- randomized controlled trial study 100 participants will be recruited to participate in the study after assigning a conset form, participants will be divided into 4 group ,one control which will not receive stretch of hamstring and 3 experimental groups will recive different duration for hamstring stretch 15,30,60 and DSSEP will be measured as the primary outcome and knee ROM will be measured as a secondary outcomes in order to identify the optimal duration of hamstring stretch
| Arm | Type | Receives |
|---|---|---|
| 15 second stretch | Experimental | Procedure: stretch hamstringStretching of the hamstring muscles was performed by the primary researcher for 15 seconds. A straight-leg-raising technique was 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 |
| 30 second stretch | Experimental | Procedure: stretch hamstringStretching of the hamstring muscles was performed by the primary researcher for 30 seconds. A straight-leg-raising technique was 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 |
| 60 second stretch | Experimental | Procedure: stretch hamstringStretching of the hamstring muscles was performed by the primary researcher for 60 seconds. A straight-leg-raising technique was 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 |
| control | Sham comparator | Procedure: stretch hamstringThe control group followed the same procedures except that no stretching force was applied at the end |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects had to 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 were also screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| stretch hamstringStretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was 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 | Procedure or surgery | 15 second stretch, 30 second stretch, 60 second stretch, control |
Primary outcome
Neurophysiological findings.
Time frame: Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session
Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.
1 secondary outcome
ROM
Time frame: Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing stretch hamstring in people with Stretch, run by Cairo University.
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 1 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Neurophysiological findings. (time frame: Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session). 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 7 Jul 2020.