<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20181228042154N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-08</date_registration>
      <primary_sponsor>University of Sargodha</primary_sponsor>
      <public_title>exercise-induced muscle damage; prophylactic and therapeutic countermeasures</public_title>
      <acronym></acronym>
      <scientific_title>Prophylactic and therapeutic effects of active isolated stretching, myofascial release and olive oil phonophoresis in exercise induced muscle damage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Other design features: The study design of the current study was a 4 X 2 X 9 factorial design with repeated measures, the three factors were intervention (s), limb (s) and time.  The repeated measures involved the time factor. The study constitutes Active isolated stretching, Myofacial release, olive oil Phonophoresis, and a control group. We had used limb to limb comparison model in each group , randomly one limb was allocated to prophylactic intervention limb (PIL) and the other to therapeutic intervention limb (TIL), Randomization description: Randomization was carried out by stratified block randomization scheme. The subjects were allocated to one of the interventional group or control group.  An independent allocator randomly allocated the participants for the allocated group. The subjects were instructed and explained about the study protocol and rating criteria of the variables, Blinding description: All the data was recorded  by a trained physical therapist of the department who was blinded about treatment and time status. He kept all record of performed intervention which was collected at the end of the study for statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Exercise induced muscle damage.</hc_freetext>
      <i_freetext>Intervention 1: Active isolated stretching Group:  The participants recieved an unassisted AIS (Agonist contraction stretching) of the flexor of the hand at the wrist joint.  After sitting on a comfortable, height adjusted chairs (90 degrees of hip and knee flexion and feet on floor), each participant was advised to actively move the hand into extension at the wrist joint, beginning the stretch of the flexors.Then requested to use their left hand to gently move the hand into further extension and apply a gentle stretch (Force should not exceed 1 pound). The stretch phase was not exceeded more than 2 seconds.  After performing the stretch, A time of 10 seconds was given to relax. The same protocol and procedure were used for all participants during the project. The participants repeated the same protocol for 8- 10 times . The prophylactic limb recieved AIS before the induction of muscle soreness, while therapeutic limb recieved AIS after the induction of muscle soreness. Intervention 2: Myofascial Release Group: The subjects in MFR group was performed self-myofascial release technique by using Tennis ball with an invariant stroking rhythm from wrist all the way to the elbow on flexor aspect of the forearm with speed of 2-3 seconds a with moderate pressure. Circular, back and forth stroking were performed in the prescribed area.The prophylactic limb recieved MFR before the induction of muscle soreness, while therapeutic limb recieved MFR after the induction of muscle soreness. Intervention 3: Olive oil Phonophoresis group. The participants recieved  1 MHz continues ultrasound (Enraf Nonius Sonopuls 490) with a power of 1 Watt/cm2 was used with a 3.5 cm diameter probe to the flexor aspect of the forearm from elbow to wrist in circular and figure of 8 manners. To ensure absorption, the probe was used at right angles. The session comprised of 10 minutes. The prophylactic limb recieved phonophorosis before the induction of muscle soreness, while therapeutic limb recieved phonophorosis after the induction of muscle soreness. Intervention 4: Control group: They follow the same routine of physical activity and diet.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After completion of the study, I will publish it

When:
Twelve months

To whom:
Faculty members and students

Conditions:
Request through email

Where to obtain:
Email to mmustafaqamar@gmail.com

How to obtain:
Email to mmustafaqamar@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Mustafa Qamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sargodha Medical College, University of Sargodha, Sargodha, Pakistan</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 9232015</telephone>
        <email>mmustafaqamar@gmail.com</email>
        <affiliation>University of Sargodha</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Mustafa Qamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sargodha Medical College, University of Sargodha, Sargodha, Pakistan</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 331 5426095</telephone>
        <email>mmustafaqamar@gmail.com</email>
        <affiliation>University of Sargodha</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy, untrained and sedentary adults age ranging between 18-30 years, without any upper arm injury or musculoskeletal disease.
Absence of any known history of cardiovascular, neurological or metabolic disorders.
Not trained for resistance training in the previous 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants were excluded who are Using Corticosteroid, NSAID or other painkillers•
Taking some herbal medicine•
Having a history of Psychiatric illness including anxiety, depression or bipolar disorder•
Having a Previous history of any surgical procedure of the shoulder, elbow or wrist within 6 months before the participation•
Having symptomatic osteoarthritis of shoulder, elbow, or wrist, •
Having any skin abnormalities of upper extremity that may affect local tolerability•
Having a History of allergy (cutaneous) •
Having a History of known analgesic, alcohol or narcotic abuse•
Having Joint hypermobility</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified soft tissue disorders, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Active isolated stretching Group:  The participants recieved an unassisted AIS (Agonist contraction stretching) of the flexor of the hand at the wrist joint.  After sitting on a comfortable, height adjusted chairs (90 degrees of hip and knee flexion and feet on floor), each participant was advised to actively move the hand into extension at the wrist joint, beginning the stretch of the flexors.Then requested to use their left hand to gently move the hand into further extension and apply a gentle stretch (Force should not exceed 1 pound). The stretch phase was not exceeded more than 2 seconds.  After performing the stretch, A time of 10 seconds was given to relax. The same protocol and procedure were used for all participants during the project. The participants repeated the same protocol for 8- 10 times . The prophylactic limb recieved AIS before the induction of muscle soreness, while therapeutic limb recieved AIS after the induction of muscle soreness.</i_keyword>
      <i_keyword>Myofascial Release Group: The subjects in MFR group was performed self-myofascial release technique by using Tennis ball with an invariant stroking rhythm from wrist all the way to the elbow on flexor aspect of the forearm with speed of 2-3 seconds a with moderate pressure. Circular, back and forth stroking were performed in the prescribed area.The prophylactic limb recieved MFR before the induction of muscle soreness, while therapeutic limb recieved MFR after the induction of muscle soreness.</i_keyword>
      <i_keyword>Olive oil Phonophoresis group. The participants recieved  1 MHz continues ultrasound (Enraf Nonius Sonopuls 490) with a power of 1 Watt/cm2 was used with a 3.5 cm diameter probe to the flexor aspect of the forearm from elbow to wrist in circular and figure of 8 manners. To ensure absorption, the probe was used at right angles. The session comprised of 10 minutes. The prophylactic limb recieved phonophorosis before the induction of muscle soreness, while therapeutic limb recieved phonophorosis after the induction of muscle soreness.</i_keyword>
      <i_keyword>Control group: They follow the same routine of physical activity and diet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Recorded at baseline, after one hour and from day 1 to 7 after the induction of muscle soreness. Method of measurement: Pain intensity was assessed by Visual analog scale.</prim_outcome>
      <prim_outcome>Muscle Soreness Score. Timepoint: Recorded at baseline, after one hour and from day 1 to 7 after the induction of muscle soreness. Method of measurement: Muscle soreness was assessed by Visual analog scale.</prim_outcome>
      <prim_outcome>Pain pressure Threshold. Timepoint: Recorded at baseline, after one hour and from day 1 to 7 after the induction of muscle soreness. Method of measurement: Pain Pressure threshold was measured by algometer (Baseline, Fabrication Enterprises, USA).</prim_outcome>
      <prim_outcome>Passive Range of motion at wrist joint. Timepoint: Recorded at baseline, after one hour and from day 1 to 7 after the induction of muscle soreness. Method of measurement: It was measured by a universal goniometer (ISOM Plastic, Isokinetics incorporation, USA).</prim_outcome>
      <prim_outcome>Grip strength. Timepoint: Recorded at baseline, after one hour and from day 1 to 7 after the induction of muscle soreness. Method of measurement: Recorded by a hand-held dynamometer (Baseline, Fabrication Enterprises, USA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Higher Education Commission, Pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-30</approval_date>
        <contact_name>University of Sargodha ethics committee</contact_name>
        <contact_address>Main university road, university of sargodha Sargodha Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
