<?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>IRCT20240323061354N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-02</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76387</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling was used to allocate patients. The allocation of the participants was done using lottery method. According to that patients were assigned into group 1 and group 2, Blinding description: The participants will be blinded in this study as they will be allocated into groups through the use of  lottery method. After carefully selecting individuals for this study, a box will be prepared with the folded chits in it. Those chits will have the names of the participants. Afterwards, a third person (random person) will be asked to draw those chits. The odd number chits will be added in the first treatment group (aerobic training group) and the chits that will be drawn at the even number, added in the second treatment group (circuit training group).</study_design>
      <phase>3</phase>
      <hc_freetext>Ataxia due to cerebellar atrophy or degeneration, stroke and multiple sclerosis..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Aerobic training group (using stationary cycle for 30 minutes duration). Intervention 2: Intervention group 2: Circuit training group. Combination of exercises (Stretching of calf and hams (30 sec hold/5 rep), bridging (1 set/5 rep), sit to stand (1 set/5 rep 30 seconds standing in each rep), stationary cycling (5 minute) and walk on parallel bars (5 minute).</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:
Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients

When:
Sharing six months after publication and it will remain available for everyone

To whom:
This will be available for everyone

Conditions:
nisar.fatima@tuf.edu.pk (0092 331 8711448)

Where to obtain:
hifzaahmed77@gmail.com (0092 304 6887080)

How to obtain:
Any applicant just need to contact at email hifzaahmed77@gmail.com (0092 304 6887080) for data/documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hifza Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67b Umer Block, Gulshan e Madina Phase 1, Sargodha Rd, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 2630517</telephone>
        <email>hifzaahmed77@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hifza Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67b Umer Block, Gulshan e Madina Phase 1, Sargodha Rd, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 2630517</telephone>
        <email>2022-ms-pt-030@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants ranging from 30-65 years of age were included in this study (mid adulthood).
Scale for Assessment and Rating of Ataxia (SARA) sitting sub-score was less than or equal to 1 (patients are able to sit and use a stationary exercise bike).
Hemodynamically stable patients.
Patient fall on stage “3 and 4” of Ataxia staging scale.
Patients were able to walk independently with or without assistive device for at least 5 minutes (as a minimum criteria).
Diagnosed ataxic patients</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient suffering from recent surgery of low back or lower limb.
Patient encountered any recent musculoskeletal injury (fracture, dislocation, soft tissue injury)
Patients suffering from heart problems/diseases.
Patients who were unable to exercise.
Medically unstable patients.
Uncooperative patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G32.81, G3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar ataxia in diseases classified elsewhere, Multiple Sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Aerobic training group (using stationary cycle for 30 minutes duration)</i_keyword>
      <i_keyword>Intervention group 2: Circuit training group. Combination of exercises (Stretching of calf and hams (30 sec hold/5 rep), bridging (1 set/5 rep), sit to stand (1 set/5 rep 30 seconds standing in each rep), stationary cycling (5 minute) and walk on parallel bars (5 minute)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease severity in ataxia. Timepoint: Before intervention and at the end of 4 weeks of intervention. Method of measurement: Scale for Assessment and Rating of Ataxia (SARA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: Before intervention and at the end of 4 weeks of intervention. Method of measurement: Berg balance scale (BBS).</sec_outcome>
      <sec_outcome>Ataxia Staging. Timepoint: Before intervention and at the end of 4 weeks of intervention. Method of measurement: Functional Staging for Ataxia.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-17</approval_date>
        <contact_name>Research and Ethics/ Technical Committee for the University of Faisalabad</contact_name>
        <contact_address>University Avenue, Faisal town, Canal road, Faisalabad. Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
