<?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>IRCT20210726051993N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-08</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of 12 weeks of music therapy to exercise on alzheimer's patients.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12 weeks of adding music therapy to exercise at home on the physical and cognitive performances of Alzheimer's patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The third person who was not in the research team will divide the subjects into 3 groups using a simple block random method. Allocating subjects to the study groups (interventions and control) will be done through block randomization using blocks of size 6. This will be by the website (https://www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, four subjects will be from the intervention groups (music group and exercise-music group) and two subjects from the control group, which will arrange randomly. Finally, eight blocks will use, Blinding description: The person who will take the tests and analyze the data is kept blind to the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alzheimer's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:  music-exercise group: Exercise group with music: Participants will train for 30 minutes 3 days a week. The exercise will be in the form of standing and sitting movements, in the form of full body and based on body weight, which will be performed rhythmically. Exercises will begin with an intensity of 30-40% of the maximum heart rate, and a small overload will be applied each week by reducing the rest time between sets. Each session will be preceded by warm-up for 10 minutes before the start of the exercise and cool down for 4-5 minutes after the exercise with stretching movements. In this group, we will play Mozart's music at the same time as exercising. The total time of the intervention will be 12 weeks, which due to coronavirus pandemic, all exercises will be at home and in the form of video contact with the trainer. Intervention 2: Intervention group 2: exercise without music: Participants will train for 30 minutes 3 days a week. The exercise will be in the form of standing and sitting movements, in the form of full body and based on body weight, which will be performed rhythmically. Exercises will begin with an intensity of 30-40% of the maximum heart rate, and a small overload will be applied each week by reducing the rest time between sets. Each session will be preceded by warm-up for 10 minutes before the start of the exercise and cool down for 4-5 minutes after the exercise with stretching movements. The total time of the intervention will be 12 weeks, which due to the coronavirus pandemic, all exercises will be at home and in the form of video contact with the trainer. Intervention 3: Control group: This group will not receive exercise and music intervention during the study, but will participate in tests (pre-test and post-test).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is For ethical reasons and without permission, personal details will not be published</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sadegh amani shalamzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>KhU, No. 43. South Mofatteh Ave., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15719-14911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>amani_sadegh@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadegh amani shalamzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>KhU, No. 43. South Mofatteh Ave., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>amani_sadegh@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild to moderate Alzheimer's
Patients age should be between 50 to 75 years
The patient should have at least one companion
the patient should have ability to walk, do light activity and daily routines</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient have severe Alzheimer's disease
The patients have any disability, injury or movement limitations
Physician's discretion not to involve the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer disease with early onset</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:  music-exercise group: Exercise group with music: Participants will train for 30 minutes 3 days a week. The exercise will be in the form of standing and sitting movements, in the form of full body and based on body weight, which will be performed rhythmically. Exercises will begin with an intensity of 30-40% of the maximum heart rate, and a small overload will be applied each week by reducing the rest time between sets. Each session will be preceded by warm-up for 10 minutes before the start of the exercise and cool down for 4-5 minutes after the exercise with stretching movements. In this group, we will play Mozart's music at the same time as exercising. The total time of the intervention will be 12 weeks, which due to coronavirus pandemic, all exercises will be at home and in the form of video contact with the trainer.</i_keyword>
      <i_keyword>Intervention group 2: exercise without music: Participants will train for 30 minutes 3 days a week. The exercise will be in the form of standing and sitting movements, in the form of full body and based on body weight, which will be performed rhythmically. Exercises will begin with an intensity of 30-40% of the maximum heart rate, and a small overload will be applied each week by reducing the rest time between sets. Each session will be preceded by warm-up for 10 minutes before the start of the exercise and cool down for 4-5 minutes after the exercise with stretching movements. The total time of the intervention will be 12 weeks, which due to the coronavirus pandemic, all exercises will be at home and in the form of video contact with the trainer.</i_keyword>
      <i_keyword>Control group: This group will not receive exercise and music intervention during the study, but will participate in tests (pre-test and post-test).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: before and after doing intervention. Method of measurement: Quality of Life in Dementia questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: pre and post intervention. Method of measurement: Pittsburgh Sleep Scale.</prim_outcome>
      <prim_outcome>Hand grip strenght. Timepoint: pre and post intervention. Method of measurement: Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chair Stand test. Timepoint: before and after the intervention. Method of measurement: stopwatch.</sec_outcome>
      <sec_outcome>Cognitive status. Timepoint: pre and post the intervention. Method of measurement: MOCA and MMSE tests.</sec_outcome>
      <sec_outcome>Verbal Fluency. Timepoint: pre and post the intervention. Method of measurement: Verbal Fluency Tes.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-20</approval_date>
        <contact_name>Ethics committee of sport science research  institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
