<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453644</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2019-06</org_study_id>
    <nct_id>NCT04453644</nct_id>
  </id_info>
  <brief_title>Effects of Stretching on Strength of Proximal and Distal Group of Muscles - A Comparative Study</brief_title>
  <official_title>Effects of Stretching on Strength of Proximal and Distal Group of Muscles - A Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscular flexibility is believed to prevent injuries and improve movement therefore most&#xD;
      coaches include stretching exercises in their pre-competition and pre-exercise warm-up&#xD;
      routines. One question arises here, should sports persons avoid stretching exercises prior to&#xD;
      sporting events thereby exposing themselves to musculoskeletal injuries, or should they&#xD;
      continue stretching exercises prior to sporting events and risk losing the maximal&#xD;
      performance? The aim of this study is to compare the effects of 2, 4, and 8 min of static&#xD;
      stretching (SS) on isometric maximum voluntary contraction (MVCF) force between proximal&#xD;
      (Hamstrings) and distal group (Calf) of muscles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVE: To compare the effects of 2, 4, and 8 min of static stretching (SS) on isometric&#xD;
      maximum voluntary contraction (MVCF) force between proximal (Hamstrings) and distal group&#xD;
      (Calf) of muscles.&#xD;
&#xD;
      DESIGN: Two-group pretest-posttest experimental design. METHODS: Each subject visited the&#xD;
      Rehabilitation center on three days: On day-I for static stretching for 2 minutes (SS2),&#xD;
      day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Isometric Maximum Voluntary&#xD;
      Contraction Force (MVCF) measurement was done prior (Pre), 0-min, 10-min, and 20-min&#xD;
      post-intervention (i.e. stretching). Each visit was separated by a gap of at least 3-4 days.&#xD;
      On each visit, each subject underwent (a). Pre-intervention evaluation, (b). Intervention,&#xD;
      (c). Post-intervention evaluation. Subjects performed stretching exercises under the&#xD;
      supervision of expert Physical Therapist. The outcome assessor who was kept blind to study&#xD;
      protocol did all measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in isometric maximum voluntary contraction force before and after stretching</measure>
    <time_frame>MVCF was measured immediately (0 min), 10-min and 20 min post intervention on 3 different days, with each day separated by gap of 3-4 days.</time_frame>
    <description>Change in isometric muscle strength measured before and after stretching using strain gauge on 3 different days</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>STRETCHING</condition>
  <arm_group>
    <arm_group_label>Group A (Hamstrings)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hamstring stretching would be done then isometric strength would be measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Calf)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calf stretching would be done then isometric strength would be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle static stretching</intervention_name>
    <description>On day-I: Static Stretching done for 2 minutes (SS2), on day-II: Static Stretching done for 4 minutes (SS4), and on day-III: Static Stretching done for 8 minutes (SS8).</description>
    <arm_group_label>Group A (Hamstrings)</arm_group_label>
    <arm_group_label>Group B (Calf)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For group A: subjects performed active knee extension test and those lacking at least 20&#xD;
        degrees of active knee extension range, with hip in 90 degree of flexion were selected. For&#xD;
        group B (Calf): Subjects performed active foot dorsiflexion in long sitting position with&#xD;
        back supported against the wall and those having not more than 20-degree range of motion&#xD;
        were selected.&#xD;
&#xD;
        Selected subjects used to engage in 1-5 hours of regular physical activity per week&#xD;
        (recreationally active) that does not involve stretching exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects reporting any current or ongoing neuromuscular disease, injury specific to lower&#xD;
        limb joints, any apparent limit in knee or ankle ROM and competitive/professional athletes&#xD;
        were excluded from study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Saud University</name>
      <address>
        <city>Riyadh</city>
        <zip>11433</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Masood Khan</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Muscle strength</keyword>
  <keyword>muscle stretching exercises</keyword>
  <keyword>strain gauge</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453644
org study id: RRC-2019-06
nct id: NCT04453644
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Muscular flexibility is believed to prevent injuries and improve movement therefore most
      coaches include stretching exercises in their pre-competition and pre-exercise warm-up
      routines. One question arises here, should sports persons avoid stretching exercises prior to
      sporting events thereby exposing themselves to musculoskeletal injuries, or should they
      continue stretching exercises prior to sporting events and risk losing the maximal
      performance? The aim of this study is to compare the effects of 2, 4, and 8 min of static
      stretching (SS) on isometric maximum voluntary contraction (MVCF) force between proximal
      (Hamstrings) and distal group (Calf) of muscles.
OBJECTIVE: To compare the effects of 2, 4, and 8 min of static stretching (SS) on isometric
      maximum voluntary contraction (MVCF) force between proximal (Hamstrings) and distal group
      (Calf) of muscles.

      DESIGN: Two-group pretest-posttest experimental design. METHODS: Each subject visited the
      Rehabilitation center on three days: On day-I for static stretching for 2 minutes (SS2),
      day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Isometric Maximum Voluntary
      Contraction Force (MVCF) measurement was done prior (Pre), 0-min, 10-min, and 20-min
      post-intervention (i.e. stretching). Each visit was separated by a gap of at least 3-4 days.
      On each visit, each subject underwent (a). Pre-intervention evaluation, (b). Intervention,
      (c). Post-intervention evaluation. Subjects performed stretching exercises under the
      supervision of expert Physical Therapist. The outcome assessor who was kept blind to study
      protocol did all measurements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in isometric maximum voluntary contraction force before and after stretching
time frame: MVCF was measured immediately (0 min), 10-min and 20 min post intervention on 3 different days, with each day separated by gap of 3-4 days.
description: Change in isometric muscle strength measured before and after stretching using strain gauge on 3 different days
arm group label: Group A (Hamstrings)
arm group type: Experimental
description: Hamstring stretching would be done then isometric strength would be measured.
arm group label: Group B (Calf)
arm group type: Experimental
description: Calf stretching would be done then isometric strength would be measured.
intervention type: Other
intervention name: Muscle static stretching
description: On day-I: Static Stretching done for 2 minutes (SS2), on day-II: Static Stretching done for 4 minutes (SS4), and on day-III: Static Stretching done for 8 minutes (SS8).
arm group label: Group A (Hamstrings)
arm group label: Group B (Calf)
criteria: 
gender: All
minimum age: 22 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Masood Khan
investigator title: Researcher
sharing ipd: No