<?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>IRCT20211018052801N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-14</date_registration>
      <primary_sponsor>Bu-Ali Sina University of Hamedan</primary_sponsor>
      <public_title>Adding Mindfulness Feldenkrais Exercises to Dynamic Neuromuscular Stability (DNS) Exercises on Pain, Activity of Selected Muscles, Postural Control and Dual Tasks Performance in Elderly with Chronic Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>Adding Mindfulness Feldenkrais Exercises to Dynamic Neuromuscular Stability (DNS) Exercises on Pain, Activity of Selected Muscles, Postural Control and Dual Tasks Performance in Elderly with Chronic Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Attention to the psychological aspect of patients in combination with the physical aspect, Randomization description: Participants will be divided into two groups, using a purposive sampling method and a Random Number Generator software. The two groups will be allocated as follows: one group will receive a combination of Feldenkrais and Dynamic Neuromuscular Stabilization exercises, while the other group will receive Dynamic Neuromuscular Stabilization exercises only, Blinding description: One of the researchers will be blinded to the group allocation and will take the assessments bbefore and after the training period. Also, the members of the groups will be blinded to the placement in the research groups due to the lack of accurate recognition of the differences in the exercise protocols used in the research and the exact purpose of each protocol.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The duration of these exercises will be eight weeks, with three sessions per week, each session lasting 90-60 minutes. At the beginning of the exercises, participants will engage in warm-up activities, and at the end of the sessions, they will focus on cooldown exercises. The exercise levels will be adjusted based on the individual abilities of the participants. The DNS exercise protocol will be implemented, considering the muscle chain reflexes, and progressively applied from a basic to advanced level. Participants will not be allowed to progress to the next level until they have sufficient mastery at lower levels. Intervention 2: In this group, the first sessions of DNS exercises and then Feldenkrais exercises will be done: Feldenkrais exercises: 1st week (leg switching duration: 15-30 minutes - rest period: 3 minutes between each set of the training program) 2nd week (posterior pelvic tilt duration: 15-30 minutes - rest period: 2 minutes between each) set). Third week (spine like a chain, duration: 30 minutes - rest period: 2 minutes between each set). 4th week (kneeling in pronation position duration: 30 minutes - rest period: 2 minutes between each set). Week 5 lying down (in the pronation position duration: 30 minutes - rest period: 2 minutes between each set). Weeks 6 to 8 all the above mastered techniques will be performed together for 30 minutes with retention periods in between the training program. The exercises will be done under the supervision of the therapists and also the subjects will be taught to do the exercises slowly and softly at home for three days.</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:
Data can potentially be shared after de-identifying individuals

When:
The access period starts one year after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
They can only use them to compare with their own data. The use of data for analysis or printing is not allowed.

Where to obtain:
Contact by email: Marziyeziyaaa@yahoo.com.

How to obtain:
State the purpose of the data request
Not to be used for printing purposes

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziyeh Ziya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516738695</zip>
        <telephone>+98 81 3838 1601</telephone>
        <email>Marziyeziyaaa@yahoo.com</email>
        <affiliation>Bu-Ali Sina University of Hamedan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Saki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan Postcode: 6516738695 Tel: 081 - 38381601</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۶۹۵۶۵۱۷۸</zip>
        <telephone>0098 813400000</telephone>
        <email>f.sport2008@gmail.com</email>
        <affiliation>Bu-Ali Sina University of Hamedan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly individuals aged 60-80 years.
A history of chronic back pain lasting more than three months.
ack pain intensity rated on a Numeric Pain Rating Scale (NPRS) between 5 and 2 out of 10.
Independence in daily activities.
No use of assistive devices.
No history of cardiovascular or respiratory diseases.
No history of severe fractures or injuries in the lower limbs and spine.
No participation in any therapeutic interventions in the past four weeks.
Willingness to participate in the research voluntarily.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of any respiratory diseases, pregnancy, or a history of surgery in the lumbar region.
Inability to perform the prescribed exercises.
Noticeable abnormalities that hinder the execution of the research.
Body mass index over 30.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The duration of these exercises will be eight weeks, with three sessions per week, each session lasting 90-60 minutes. At the beginning of the exercises, participants will engage in warm-up activities, and at the end of the sessions, they will focus on cooldown exercises. The exercise levels will be adjusted based on the individual abilities of the participants. The DNS exercise protocol will be implemented, considering the muscle chain reflexes, and progressively applied from a basic to advanced level. Participants will not be allowed to progress to the next level until they have sufficient mastery at lower levels.</i_keyword>
      <i_keyword>In this group, the first sessions of DNS exercises and then Feldenkrais exercises will be done: Feldenkrais exercises: 1st week (leg switching duration: 15-30 minutes - rest period: 3 minutes between each set of the training program) 2nd week (posterior pelvic tilt duration: 15-30 minutes - rest period: 2 minutes between each) set). Third week (spine like a chain, duration: 30 minutes - rest period: 2 minutes between each set). 4th week (kneeling in pronation position duration: 30 minutes - rest period: 2 minutes between each set). Week 5 lying down (in the pronation position duration: 30 minutes - rest period: 2 minutes between each set). Weeks 6 to 8 all the above mastered techniques will be performed together for 30 minutes with retention periods in between the training program. The exercises will be done under the supervision of the therapists and also the subjects will be taught to do the exercises slowly and softly at home for three days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: The variable will be measured 1-4 days before the start of the exercise sessions and three days after the exercise sessions. Method of measurement: Measurements by the Numeric Pain Rating Scale (NPRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Control posture. Timepoint: The variable will be measured 1-4 days before the start of the exercise sessions and three days after the exercise sessions. Method of measurement: Measurements by Berg Balance Scale.</sec_outcome>
      <sec_outcome>Electrical activity of the muscles. Timepoint: The variable will be measured 1-4 days before the start of the exercise sessions and three days after the exercise sessions. Method of measurement: Measurements by  surface electromyography (EMG).</sec_outcome>
      <sec_outcome>Functional tests. Timepoint: The variable will be measured 1-4 days before the start of the exercise sessions and three days after the exercise sessions. Method of measurement: Measurements by Time Up and Go (TUG) test for both motor and cognitive assessment.</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>Bu-Ali Sina University of Hamedan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-20</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St. Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
