<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188030</url>
  </required_header>
  <id_info>
    <org_study_id>480.968</org_study_id>
    <nct_id>NCT02188030</nct_id>
  </id_info>
  <brief_title>Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled Trial</brief_title>
  <acronym>Exercise</acronym>
  <official_title>Individual Exercise Program for Industrial Workers With Complaints of the Arm, Neck, or Shoulder (CANS): Study Protocol for a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rosimeire Simprini Padula</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is double-blinded RCT, whose aim is to assess if an individual exercise program is&#xD;
      more effective to reduce complaints in neck, shoulders and arms that an group exercise&#xD;
      program, in industrial workers.&#xD;
&#xD;
      The participants will be randomly allocated to receive 12 treatment sessions of individual&#xD;
      exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes&#xD;
      and will be held twice a week for 12 weeks. Participants will also be encouraged to continue&#xD;
      the use of medicines and other health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is double-blinded RCT. Participants will be recruited from employees of the&#xD;
      companies and industries located in the South of Bahia, Brazil or by referral from general&#xD;
      practitioners, orthopedists, This study is single-blinded RCT, whose aim is to assess the&#xD;
      efficacy of an individual exercise program for employees with complaints in neck, shoulders&#xD;
      and arms. Participants will be recruited from employees of the companies and industries&#xD;
      located in Brazil or by referral from general practitioners, orthopedists, neurologists or&#xD;
      physiatrists.&#xD;
&#xD;
      The sample of 100 participants was determined by a sample size calculation designed to detect&#xD;
      a clinically important difference of 10 points in the DASH Questionnaire (estimated standard&#xD;
      deviation = 16,65 points). The following specifications will be considered: α=0.05,&#xD;
      statistical power of 80% and follow-up loss of up to 15%.&#xD;
&#xD;
      The participants will be randomly allocated to receive 12 treatment sessions of individual&#xD;
      exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes&#xD;
      and will be held twice a week for 12 weeks. Participants will also be encouraged to continue&#xD;
      the use of medicines and other health care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity during and after treatment</measure>
    <time_frame>6th and 12th week after the start of treatment</time_frame>
    <description>Numeric Pain Rating Scale (NPRS) assesses the pain intensity levels perceived by the patient using likert 11-point scale (ranging from 0 to 10), with 0 representing &quot;no pain&quot; and 10 representing &quot;the worst possible pain&quot;. The participants will be instructed to report the level of pain intensity in the last seven days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Impression of Recovery</measure>
    <time_frame>6th and 12th week after treatment</time_frame>
    <description>The Global Perceived Effect Scale assesses the patient's perception, on a numerical scale, about how much their condition has improved or deteriorated comparing the onset of symptoms to the last few days. It is an 11-point numerical scale ranging -5 to +5, where the negative scores means that the patients are worsening, and the positive scores means refer positive that patients are recovering compared to the beginning. This scale has adequate clinimetric properties and it has been recommended for use as outcome measure for chronic pain trials 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>Baseline, 6th and 12th week after treatment</time_frame>
    <description>Disability Arm, Shoulder and Hand Questionnaire (DASH) is a questionnaire used to measure of disability and symptoms in the previous week of arm, shoulder and hand. The questionnaire uses a likert 5-point scale Likert (ranging from 1 to 5), with 1 means &quot;no difficulty to perform, no symptom or no impact&quot;) and 5 means &quot;unable to do, very severe symptom, or high impact&quot;. The total score ranges from 0 to 10, where 0 &quot;no dysfunction&quot; and 100 &quot;severe impairment&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Musculoskeletal Disorder of the Neck</condition>
  <arm_group>
    <arm_group_label>Group Exercise Training (GET).</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group Exercise Program. The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum 12. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Exercise Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individual Exercise Program. The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al. and Sundstrup et al . During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group Exercise Program</intervention_name>
    <description>The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.</description>
    <arm_group_label>Group Exercise Training (GET).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individual Exercise Program</intervention_name>
    <description>The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al.3 and Sundstrup et al4.&#xD;
During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload5. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.</description>
    <arm_group_label>Individual Exercise Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnose of nontraumatic complaints of the arm, neck or shoulder with minimum&#xD;
             intensity of 4 points on the visual analogue pain scale1, for at least 6 weeks2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with contraindication to physical exercise&#xD;
&#xD;
          -  Participants who had been diagnosed with cervical disc hernia; shoulder instability;&#xD;
             fractures; frozen shoulder; systemic diseases such as rheumatoid arthritis or&#xD;
             diabetes; neurological diseases or other severe medical or psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosimeire Padula, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Cidade de São Paulo (UNICID)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Luiza Comper, Msc.</last_name>
    <phone>+557388220614</phone>
    <email>marialuizacaires21@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>União Metropolitana de Ensino e Cultura (UNIME)</name>
      <address>
        <city>Itabuna</city>
        <state>Bahia</state>
        <zip>45600-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Luiza Comper, Msc</last_name>
      <phone>+557388220614</phone>
      <email>marialuizacaires21@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Maria Luiza Comper, Msc.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Cidade de Sao Paulo</investigator_affiliation>
    <investigator_full_name>Rosimeire Simprini Padula</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>musculoskeletal symptom</keyword>
  <keyword>industrial workers</keyword>
  <keyword>physical-activity program</keyword>
  <keyword>resistance training</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188030
org study id: 480.968
nct id: NCT02188030
lead sponsor: 
has dmc: Yes
This study is double-blinded RCT, whose aim is to assess if an individual exercise program is
      more effective to reduce complaints in neck, shoulders and arms that an group exercise
      program, in industrial workers.

      The participants will be randomly allocated to receive 12 treatment sessions of individual
      exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes
      and will be held twice a week for 12 weeks. Participants will also be encouraged to continue
      the use of medicines and other health care.
This study is double-blinded RCT. Participants will be recruited from employees of the
      companies and industries located in the South of Bahia, Brazil or by referral from general
      practitioners, orthopedists, This study is single-blinded RCT, whose aim is to assess the
      efficacy of an individual exercise program for employees with complaints in neck, shoulders
      and arms. Participants will be recruited from employees of the companies and industries
      located in Brazil or by referral from general practitioners, orthopedists, neurologists or
      physiatrists.

      The sample of 100 participants was determined by a sample size calculation designed to detect
      a clinically important difference of 10 points in the DASH Questionnaire (estimated standard
      deviation = 16,65 points). The following specifications will be considered: α=0.05,
      statistical power of 80% and follow-up loss of up to 15%.

      The participants will be randomly allocated to receive 12 treatment sessions of individual
      exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes
      and will be held twice a week for 12 weeks. Participants will also be encouraged to continue
      the use of medicines and other health care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in pain intensity during and after treatment
time frame: 6th and 12th week after the start of treatment
description: Numeric Pain Rating Scale (NPRS) assesses the pain intensity levels perceived by the patient using likert 11-point scale (ranging from 0 to 10), with 0 representing "no pain" and 10 representing "the worst possible pain". The participants will be instructed to report the level of pain intensity in the last seven days.
measure: Global Impression of Recovery
time frame: 6th and 12th week after treatment
description: The Global Perceived Effect Scale assesses the patient's perception, on a numerical scale, about how much their condition has improved or deteriorated comparing the onset of symptoms to the last few days. It is an 11-point numerical scale ranging -5 to +5, where the negative scores means that the patients are worsening, and the positive scores means refer positive that patients are recovering compared to the beginning. This scale has adequate clinimetric properties and it has been recommended for use as outcome measure for chronic pain trials 15.
measure: Disability
time frame: Baseline, 6th and 12th week after treatment
description: Disability Arm, Shoulder and Hand Questionnaire (DASH) is a questionnaire used to measure of disability and symptoms in the previous week of arm, shoulder and hand. The questionnaire uses a likert 5-point scale Likert (ranging from 1 to 5), with 1 means "no difficulty to perform, no symptom or no impact") and 5 means "unable to do, very severe symptom, or high impact". The total score ranges from 0 to 10, where 0 "no dysfunction" and 100 "severe impairment".
arm group label: Group Exercise Training (GET).
arm group type: Active Comparator
description: Group Exercise Program. The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum 12. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.
arm group label: Individual Exercise Training
arm group type: Active Comparator
description: Individual Exercise Program. The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al. and Sundstrup et al . During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.
intervention type: Other
intervention name: Group Exercise Program
description: The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.
arm group label: Group Exercise Training (GET).
intervention type: Other
intervention name: Individual Exercise Program
description: The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al.3 and Sundstrup et al4.
During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload5. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.
arm group label: Individual Exercise Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Rosimeire Padula, Doctor
role: Principal Investigator
affiliation: Universidade Cidade de São Paulo (UNICID)
last name: Maria Luiza Comper, Msc.
phone: +557388220614
email: marialuizacaires21@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Rosimeire Simprini Padula
investigator title: PhD
mesh term: Musculoskeletal Diseases