<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/NCT04426864</url>
  </required_header>
  <id_info>
    <org_study_id>2018TIPF044</org_study_id>
    <nct_id>NCT04426864</nct_id>
  </id_info>
  <brief_title>Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.</brief_title>
  <official_title>Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To demonstrate the most effective exercise intervention for women with&#xD;
      fibromyalgia syndrome on the pain, quality of life, depression, and body composition through&#xD;
      a comparative study of three types of exercise intervention: supervised aerobic plus&#xD;
      stretching, supervised resistance plus stretching, and home-based stretching.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To demonstrate the most effective exercise intervention for women with&#xD;
      fibromyalgia syndrome on the pain, quality of life, depression, and body composition through&#xD;
      a comparative study of three types of exercise intervention.&#xD;
&#xD;
      Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups:&#xD;
      supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance&#xD;
      plus stretching exercises group (group II, n:28) and home-based stretching exercises group&#xD;
      (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 %&#xD;
      ergospirometric VO2max were determined by the submaximal treadmill test. Group I was&#xD;
      instructed walking at their target HR on a treadmill. Exercise intensity in group II was&#xD;
      determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise&#xD;
      at home. All participants were instructed to perform stretching exercises. Before and after a&#xD;
      12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total&#xD;
      body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire&#xD;
      (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).&#xD;
&#xD;
      Study Type: Interventional (Clinical Trial)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>
    <intervention_model_description>Participants are assigned to three groups in parallel for the duration of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in analogue scale (VAS) score at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Short Form 36 (SF-36) score at week 12.</measure>
    <time_frame>Week 12</time_frame>
    <description>Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in weight (kilograms) at week 12.</measure>
    <time_frame>Week 12</time_frame>
    <description>Weight was measured with body composition analyzer (Tanita MC580).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in body mass index (BMI) at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in total body fat percentage at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Total body fat percentage was measured with body composition analyzer (Tanita MC580).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in in total body muscle percentage at week 12.</measure>
    <time_frame>Week 12</time_frame>
    <description>Total body muscle percentage was measured with body composition analyzer (Tanita MC580).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in blood lactate concentration at rest (mmol/L) at week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Fibromyalgia Syndrome</condition>
  <arm_group>
    <arm_group_label>Supervised Aerobic Plus Stretching Exercises Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised Resistance Plus Stretching Exercises Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based Stretching Exercises Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants were instructed to perform the stretching exercises at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised Aerobic Plus Stretching Exercises</intervention_name>
    <description>An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.</description>
    <arm_group_label>Supervised Aerobic Plus Stretching Exercises Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supervised Resistance Plus Stretching Exercises Group</intervention_name>
    <description>According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.</description>
    <arm_group_label>Supervised Resistance Plus Stretching Exercises Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-based Stretching Exercises Group</intervention_name>
    <description>Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.</description>
    <arm_group_label>Home-based Stretching Exercises Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants who meet the criteria for inclusion were women with Fibromyalgia&#xD;
             Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were&#xD;
             18-65 years old.&#xD;
&#xD;
          -  Participants were well communicative, motivated, and willing to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • The exclusion criteria were the presence of uncontrolled hypertension, history of&#xD;
        myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart&#xD;
        failure (New York Heart Association), musculoskeletal or systemic diseases contradicting&#xD;
        the exercise, a neurological or psychiatric disease affecting cooperation and cognitive&#xD;
        function, presence of active inflammation and immunosuppression.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant eligibility is based on the self-representation of gender identity.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fusun ARDIC, Prof.M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University Faculty of Medicine</name>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Füsun Ardıç</investigator_full_name>
    <investigator_title>Director, Head of Physical Medicine and Rehabilitation, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <keyword>Aerobic exercise</keyword>
  <keyword>Resistance exercise</keyword>
  <keyword>Stretching exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT04426864
org study id: 2018TIPF044
nct id: NCT04426864
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To demonstrate the most effective exercise intervention for women with
      fibromyalgia syndrome on the pain, quality of life, depression, and body composition through
      a comparative study of three types of exercise intervention: supervised aerobic plus
      stretching, supervised resistance plus stretching, and home-based stretching.
Objective: To demonstrate the most effective exercise intervention for women with
      fibromyalgia syndrome on the pain, quality of life, depression, and body composition through
      a comparative study of three types of exercise intervention.

      Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups:
      supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance
      plus stretching exercises group (group II, n:28) and home-based stretching exercises group
      (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 %
      ergospirometric VO2max were determined by the submaximal treadmill test. Group I was
      instructed walking at their target HR on a treadmill. Exercise intensity in group II was
      determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise
      at home. All participants were instructed to perform stretching exercises. Before and after a
      12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total
      body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire
      (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).

      Study Type: Interventional (Clinical Trial)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to three groups in parallel for the duration of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in analogue scale (VAS) score at week 12
time frame: Week 12
description: Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
measure: Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
time frame: Week 12
description: The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
measure: Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
time frame: Week 12
description: This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
measure: Change from baseline in Short Form 36 (SF-36) score at week 12.
time frame: Week 12
description: Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
measure: Change from baseline in weight (kilograms) at week 12.
time frame: Week 12
description: Weight was measured with body composition analyzer (Tanita MC580).
measure: Change from baseline in body mass index (BMI) at week 12
time frame: Week 12
description: Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
measure: Change from baseline in total body fat percentage at week 12
time frame: Week 12
description: Total body fat percentage was measured with body composition analyzer (Tanita MC580).
measure: Change from baseline in in total body muscle percentage at week 12.
time frame: Week 12
description: Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
measure: Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
time frame: Week 12
description: Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
arm group label: Supervised Aerobic Plus Stretching Exercises Group
arm group type: Active Comparator
description: The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
arm group label: Supervised Resistance Plus Stretching Exercises Group
arm group type: Experimental
description: The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
arm group label: Home-based Stretching Exercises Group
arm group type: Experimental
description: The participants were instructed to perform the stretching exercises at home.
intervention type: Other
intervention name: Supervised Aerobic Plus Stretching Exercises
description: An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.
arm group label: Supervised Aerobic Plus Stretching Exercises Group
intervention type: Other
intervention name: Supervised Resistance Plus Stretching Exercises Group
description: According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.
arm group label: Supervised Resistance Plus Stretching Exercises Group
intervention type: Other
intervention name: Home-based Stretching Exercises Group
description: Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.
arm group label: Home-based Stretching Exercises Group
criteria: 
gender: Female
gender based: Yes
gender description: Participant eligibility is based on the self-representation of gender identity.
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fusun ARDIC, Prof.M.D.
role: Study Director
affiliation: Pamukkale University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Füsun Ardıç
investigator title: Director, Head of Physical Medicine and Rehabilitation, Principal Investigator, Clinical Professor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Syndrome