<?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>IRCT20210505051181N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-09</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of proprioceptive neuromuscular facilitation techniques and aerobic exercises in elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of proprioceptive neuromuscular facilitation techniques in comparison with aerobic exercises on functional balance, fear of falling and quality of life in elderly-a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present research will be based on the blinding method in which the assessor will unaware of the grouping, not only before the intervention but also after that, Randomization description: The people of both groups are identical in terms of demographic characteristics and are randomly divided into one of the two treatment groups with a ratio of 1:1. Random allocation is done using block balanced randomization, which includes 4-letter blocks of letters A and B. This treatment allocation is placed in numbered envelopes consisting of letters A and B. The person who sit up the randomization sequence will not involved in any of the phases of research process.
Group A includes rhythmic stabilization and stabilizing reversal techniques. Group B includes aerobic exercises. After initial evaluations by the assessor, numbered envelopes which were prepared based on a consecutive number are provided to each person participating in the study. In addition, therapeutic intervention is adjusted according to the letters in the envelope. The assessor will not aware of this.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aging.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (group A):The elderly will treat 3 days a week for 4 weeks having a total of 12 sessions. Before starting the exercises, 5 to 7 minutes active warm-up is be done. Each exercise has 3 repetitions and each repetition takes 15 seconds. 1- Whole body stretch (clasped hands are stretched above the head). 2- Upper trapezius muscle stretch 3- Wrist flexor muscles stretch 4- Wrist extensor muscles stretch 5- Lunge movement. Then the rhythmic stabilization technique is performed in lower trunk. After 2 minutes of rest, the stabilizing reversal technique is performed in the same body part. Each technique is performed in 3 sets and there are 10 repetitions in each set. There are 60 seconds rest between sets and 30 seconds rest between repetitions. Performing and holding each repetition of both rhythmic stabilization and stabilizing reversal techniques takes 10 seconds. Rhythmic Stabilization Technique: This technique utilizes isometric agonist and antagonist muscles co-contraction. Performing this technique, we don’t have any movement. As a result, the older adult has a verbal command like: "Don't let me move you. Hold on." The person is in a sitting position and this technique will be perform on the trunk flexors and extensors. Stabilizing Reversal Technique: The position of the person to perform this technique is similar to rhythmic stabilization technique, there is just a difference. This technique utilizes alternating isotonic contractions of first agonist muscle, then without any rest antagonist muscle. The time needed to perform all PNF techniques is about 40 minutes. Ending the exercises we require a 6-minute cool-down, which includes:1. performing a stretching exercise in supine position, where the person bends the knees and holds them with both hands and will pull them towards himself. There are 2 repetitions, each repetition takes about 20-30 Seconds.2.The person will relax the body in supine position while closing eyes for 5 minutes (shavasana relaxation). Intervention 2: Control group (group B): The elderly will treat 3 days a week for 4 weeks and there will be a total of 12 sessions. Before starting the exercises, we have 5 to 7 minutes of active warm-up so that there are 3 repetitions of each exercise and each repetition holds for 15 seconds. 1. Whole body stretch (clasped hands are stretched above the head.) 2- Upper trapezius muscle stretch 3- Wrist flexor muscles stretch 4- Wrist extensor muscles stretch 5- Lunge movement. Then the elderly will walk for 40 minutes outdoors under the supervision of the therapist. While walking, the Accupedo Pedometer software will use as a step counter application. Consequently, the elderly will encourage to increase the number of steps. Ending the exercises, we have a 6-minute cool-down, which includes 1. Performing a stretching exercise in supine position, where the person bends the knees and holds them with both hands and will pull them towards themselves. There are 2 repetitions and each repetition takes 20-30 seconds.2.The person will relax the body in supine position closing eyes for 5 minutes (shavasana relaxation).</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 be shared after making participants unrecognizable.

When:
Start access period 6 months after the results publication

To whom:
People in medicine and rehabilitation field

Conditions:
Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author.

Where to obtain:
Email the researcher- Mina Ansari Eshlaghi- ansari77mina@gmail.com

How to obtain:
6 months after the publication of the results, information will be given to the applicant within a week by emailing the researcher.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Ansari Eshlaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy, School of Rehabilitation Science, Iran University of Medical Sciences, Madadkaran St., Shah Nazari Ave, Madar Square, Mirdamad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>ansari77mina@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehrnaz Kajbafvala</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dastgerdi (Zafar) Ave, Aliasghar Children Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6688</telephone>
        <email>kajbafvala.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 60 years old
Mini-Mental state examination score ≥24
Not to use assistive devices during walking
The ability to stand without assistive device
Absence of any physical and movement restrictions in pelvic, hip and knee joints to participate in exercises and tests
Ability to exercise for 30 min
Walking 30 m or more without assistance
Literate people
Berg test score between 21 to 48</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neuromusculoskeletal disease, Severe and mobility limiting arthritis, Ankle surgery and instability, Lower limb nerve injury (neuropathy), Back and lower limb injury (symptoms within the last 6 months), Structural  deficit, History of lower limb fracture within the last 10 years, Severe osteoporosis
Neurological deficit, Psychological disease, Anticonvulsant drug use, Dementia, Sedative use
General medical problem, Neuropathy according to diabetes, Renal and liver disease, Current acute illness or pain, Cancer and autoimmune disease
Neurovestibular (vestibular) disease
Unstable or ongoing cardiovascular/respiratory disorders
Hearing loss (do not use hearing aids) and visual impairment (cannot see)
Frequent performance of PNF in the past</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 (group A):The elderly will treat 3 days a week for 4 weeks having a total of 12 sessions. Before starting the exercises, 5 to 7 minutes active warm-up is be done. Each exercise has 3 repetitions and each repetition takes 15 seconds. 1- Whole body stretch (clasped hands are stretched above the head). 2- Upper trapezius muscle stretch 3- Wrist flexor muscles stretch 4- Wrist extensor muscles stretch 5- Lunge movement. Then the rhythmic stabilization technique is performed in lower trunk. After 2 minutes of rest, the stabilizing reversal technique is performed in the same body part. Each technique is performed in 3 sets and there are 10 repetitions in each set. There are 60 seconds rest between sets and 30 seconds rest between repetitions. Performing and holding each repetition of both rhythmic stabilization and stabilizing reversal techniques takes 10 seconds. Rhythmic Stabilization Technique: This technique utilizes isometric agonist and antagonist muscles co-contraction. Performing this technique, we don’t have any movement. As a result, the older adult has a verbal command like: "Don't let me move you. Hold on." The person is in a sitting position and this technique will be perform on the trunk flexors and extensors. Stabilizing Reversal Technique: The position of the person to perform this technique is similar to rhythmic stabilization technique, there is just a difference. This technique utilizes alternating isotonic contractions of first agonist muscle, then without any rest antagonist muscle. The time needed to perform all PNF techniques is about 40 minutes. Ending the exercises we require a 6-minute cool-down, which includes:1. performing a stretching exercise in supine position, where the person bends the knees and holds them with both hands and will pull them towards himself. There are 2 repetitions, each repetition takes about 20-30 Seconds.2.The person will relax the body in supine position while closing eyes for 5 minutes (shavasana relaxation).</i_keyword>
      <i_keyword>Control group (group B): The elderly will treat 3 days a week for 4 weeks and there will be a total of 12 sessions. Before starting the exercises, we have 5 to 7 minutes of active warm-up so that there are 3 repetitions of each exercise and each repetition holds for 15 seconds. 1. Whole body stretch (clasped hands are stretched above the head.) 2- Upper trapezius muscle stretch 3- Wrist flexor muscles stretch 4- Wrist extensor muscles stretch 5- Lunge movement. Then the elderly will walk for 40 minutes outdoors under the supervision of the therapist. While walking, the Accupedo Pedometer software will use as a step counter application. Consequently, the elderly will encourage to increase the number of steps. Ending the exercises, we have a 6-minute cool-down, which includes 1. Performing a stretching exercise in supine position, where the person bends the knees and holds them with both hands and will pull them towards themselves. There are 2 repetitions and each repetition takes 20-30 seconds.2.The person will relax the body in supine position closing eyes for 5 minutes (shavasana relaxation).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional balance. Timepoint: Before starting the intervention and after the four weeks intervention. Method of measurement: Functional balance tests:1-Berg balance scale 2-Functional reach test 3-Timed up and go test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of falling. Timepoint: Before starting the intervention and after the four weeks intervention. Method of measurement: Persian version of fall efficacy scale questionnaire-international form.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before starting the intervention and after the four weeks intervention. Method of measurement: Persian version of  World Health Organization quality of life questionnaire-Older Adults Edition.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-06</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Near Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
