Optimal Duration of Stretching of the Hamstring Muscle Group

October 29, 2020 updated by: Ibrahim Moustafa, University of Sharjah

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • United Arab Emirate
      • Sharjah, United Arab Emirate, United Arab Emirates, 27272
        • Ibrahim Moustafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 seconds
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.
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position
Experimental: 30 seconds
the same stretching technique will continue for 30 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times.
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position
Experimental: 60 seconds
the same stretching technique will continue for 60 seconds .The patient relaxed for approximately 20s and the procedure was repeated three times.
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position
Sham Comparator: control
The control group followed the same procedures except that no stretching force was applied at the end.
Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-treatment , immediately after treatment and at 24 hours after the treatment .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in range of motion
Time Frame: pre-treatment , immediately after treatment and at 24 hours after the treatment .
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.
pre-treatment , immediately after treatment and at 24 hours after the treatment .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ibrahim Moustafa, professor, University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • USharjah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe