<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/NCT04488809</url>
  </required_header>
  <id_info>
    <org_study_id>DWRVSTR</org_study_id>
    <nct_id>NCT04488809</nct_id>
  </id_info>
  <brief_title>Comparison the Effects of Deep Water Running and Treadmill Running</brief_title>
  <official_title>Comparison the Effects of Deep Water Running and Treadmill Running on Lower Extremity Anaerobic Exercise Performance in Sedentary Young Adults: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Katip Celebi 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>
      The aim of this study is to compare the effectiveness of different exercise programs as 'Deep&#xD;
      Water Running' and 'Treadmill Running' in sedentary young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid and explosive movements such as jumping or stair climbing need anaerobic performance.&#xD;
      Anaerobic performance is negatively affected by sedentary behaviour due to loss of muscle&#xD;
      strength and endurance. Exercise is an effective method to increase muscle strength and&#xD;
      physical performance.&#xD;
&#xD;
      Exercising in water has unique physiological characteristics such as buoyancy, hydrostatic&#xD;
      pressure, and metacentric effect. In addition, exercising in high speeds in water leads&#xD;
      strengthening. Deep water running is employed to imitate the running on land. It is advocated&#xD;
      that deep water running might result additional benefits than running on land. Therefore, the&#xD;
      effect of the present study is to compare the effectiveness of deep water running and&#xD;
      treadmill running in sedentary young adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2021</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in lower extremity anaerobic performance</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>The lower extremity anaerobic performance will be measured by using Wingate Anaerobic Capacity Test. The average power (watt, watt/kg), and peak power (watt/watt/kg) will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lower extremity strength</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>The strengths of M. Quadriceps Femoris, M. Gluteus Maximus, and M. Gastrocnemius will be assessed by using a hand-held dynamometer. Muscle strength will be recorded in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in agility</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>T agility test will be used for evaluating agility. The time will be recorded for completing the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in trunk muscle endurance</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Side bridge position will be employed to measure the trunk muscles endurance. The time until the failure in the position will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Fatigue will be assessed by using Fatigue Severity Scale. It includes nine items, and each item is scored between 1-7 (1: totally disagree, 7: totally agree). Higher scores indicate higher levels of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total body mass</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Total body mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Fat mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat free muscle mass</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Fat free muscle mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in basal metabolism rate</measure>
    <time_frame>At baseline and 8 weeks later</time_frame>
    <description>Basal metabolism will be measured by analyzing gas exchange in rest position. Oxygen consumption and carbon dioxide production will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>Deep Water Running</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will perform running in a vertical position in water. The sessions will be held in deep pool where the feet of the participants will not touch the ground.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill Running</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will perform running on a treadmill.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will not interfere regular exercise for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise sessions will include 10 minutes of warming up, 30 minutes of loading, and 10 minutes of cooling down. The exercises will be performed two times in a week for eight weeks.</description>
    <arm_group_label>Deep Water Running</arm_group_label>
    <arm_group_label>Treadmill Running</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being sedentary according to International Physical Activity Questionnaire&#xD;
&#xD;
          -  Consent of the participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Problems related to musculoskeletal, neurologic, and cardiopulmonary systems in last&#xD;
             six months&#xD;
&#xD;
          -  Any contraindication to exercise in water (water fear, allergy to chlorine)&#xD;
&#xD;
          -  No willingness to continue in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Deniz Bayraktar, PhD</last_name>
    <phone>+90 232 329 35 35</phone>
    <phone_ext>4833</phone_ext>
    <email>ptdenislav@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Izmir Katip Celebi University</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
    <contact>
      <last_name>Deniz Bayraktar, PhD.</last_name>
      <phone>+90 232 329 35 35</phone>
      <phone_ext>4833</phone_ext>
      <email>ptdenislav@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kelly BT, Roskin LA, Kirkendall DT, Speer KP. Shoulder muscle activation during aquatic and dry land exercises in nonimpaired subjects. J Orthop Sports Phys Ther. 2000 Apr;30(4):204-10. doi: 10.2519/jospt.2000.30.4.204.</citation>
    <PMID>10778797</PMID>
  </reference>
  <reference>
    <citation>Reichert T, Kanitz AC, Delevatti RS, Bagatini NC, Barroso BM, Kruel LF. Continuous and interval training programs using deep water running improves functional fitness and blood pressure in the older adults. Age (Dordr). 2016 Feb;38(1):20. doi: 10.1007/s11357-016-9882-5. Epub 2016 Feb 3.</citation>
    <PMID>26841888</PMID>
  </reference>
  <reference>
    <citation>Cuesta-Vargas AI, Buchan J, Arroyo-Morales M. A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. Eur J Cancer Care (Engl). 2014 Jan;23(1):15-21. doi: 10.1111/ecc.12114. Epub 2013 Aug 16.</citation>
    <PMID>23947581</PMID>
  </reference>
  <reference>
    <citation>Cuesta-Vargas AI, Adams N, Salazar JA, Belles A, Hazanas S, Arroyo-Morales M. Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial. Clin Rheumatol. 2012 Jul;31(7):1073-8. doi: 10.1007/s10067-012-1977-5. Epub 2012 Mar 29.</citation>
    <PMID>22453844</PMID>
  </reference>
  <reference>
    <citation>Wilber RL, Moffatt RJ, Scott BE, Lee DT, Cucuzzo NA. Influence of water run training on the maintenance of aerobic performance. Med Sci Sports Exerc. 1996 Aug;28(8):1056-62. doi: 10.1097/00005768-199608000-00017.</citation>
    <PMID>8871917</PMID>
  </reference>
  <reference>
    <citation>Broman G, Quintana M, Lindberg T, Jansson E, Kaijser L. High intensity deep water training can improve aerobic power in elderly women. Eur J Appl Physiol. 2006 Sep;98(2):117-23. doi: 10.1007/s00421-006-0237-2. Epub 2006 Aug 22.</citation>
    <PMID>16924529</PMID>
  </reference>
  <reference>
    <citation>Bayraktar D, Savci S, Altug-Gucenmez O, Manci E, Makay B, Ilcin N, Unsal E. The effects of 8-week water-running program on exercise capacity in children with juvenile idiopathic arthritis: a controlled trial. Rheumatol Int. 2019 Jan;39(1):59-65. doi: 10.1007/s00296-018-4209-8. Epub 2018 Nov 14.</citation>
    <PMID>30430201</PMID>
  </reference>
  <reference>
    <citation>Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.</citation>
    <PMID>3324256</PMID>
  </reference>
  <reference>
    <citation>Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.</citation>
    <PMID>9014953</PMID>
  </reference>
  <reference>
    <citation>Raya MA, Gailey RS, Gaunaurd IA, Jayne DM, Campbell SM, Gagne E, Manrique PG, Muller DG, Tucker C. Comparison of three agility tests with male servicemembers: Edgren Side Step Test, T-Test, and Illinois Agility Test. J Rehabil Res Dev. 2013;50(7):951-60. doi: 10.1682/JRRD.2012.05.0096.</citation>
    <PMID>24301432</PMID>
  </reference>
  <reference>
    <citation>McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.</citation>
    <PMID>10453772</PMID>
  </reference>
  <reference>
    <citation>Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.</citation>
    <PMID>17293726</PMID>
  </reference>
  <reference>
    <citation>Jebb SA, Cole TJ, Doman D, Murgatroyd PR, Prentice AM. Evaluation of the novel Tanita body-fat analyser to measure body composition by comparison with a four-compartment model. Br J Nutr. 2000 Feb;83(2):115-22. doi: 10.1017/s0007114500000155.</citation>
    <PMID>10743490</PMID>
  </reference>
  <reference>
    <citation>Vandarakis D, Salacinski AJ, Broeder CE. A comparison of COSMED metabolic systems for the determination of resting metabolic rate. Res Sports Med. 2013;21(2):187-94. doi: 10.1080/15438627.2012.757226.</citation>
    <PMID>23541105</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
    <investigator_full_name>Deniz Bayraktar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Running</keyword>
  <keyword>Anaerobic Performance</keyword>
  <keyword>Agility</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04488809
org study id: DWRVSTR
nct id: NCT04488809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the effectiveness of different exercise programs as 'Deep
      Water Running' and 'Treadmill Running' in sedentary young adults.
Rapid and explosive movements such as jumping or stair climbing need anaerobic performance.
      Anaerobic performance is negatively affected by sedentary behaviour due to loss of muscle
      strength and endurance. Exercise is an effective method to increase muscle strength and
      physical performance.

      Exercising in water has unique physiological characteristics such as buoyancy, hydrostatic
      pressure, and metacentric effect. In addition, exercising in high speeds in water leads
      strengthening. Deep water running is employed to imitate the running on land. It is advocated
      that deep water running might result additional benefits than running on land. Therefore, the
      effect of the present study is to compare the effectiveness of deep water running and
      treadmill running in sedentary young adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in lower extremity anaerobic performance
time frame: At baseline and 8 weeks later
description: The lower extremity anaerobic performance will be measured by using Wingate Anaerobic Capacity Test. The average power (watt, watt/kg), and peak power (watt/watt/kg) will be recorded.
measure: Change in lower extremity strength
time frame: At baseline and 8 weeks later
description: The strengths of M. Quadriceps Femoris, M. Gluteus Maximus, and M. Gastrocnemius will be assessed by using a hand-held dynamometer. Muscle strength will be recorded in kilograms.
measure: Change in agility
time frame: At baseline and 8 weeks later
description: T agility test will be used for evaluating agility. The time will be recorded for completing the test.
measure: Change in trunk muscle endurance
time frame: At baseline and 8 weeks later
description: Side bridge position will be employed to measure the trunk muscles endurance. The time until the failure in the position will be recorded.
measure: Change in fatigue
time frame: At baseline and 8 weeks later
description: Fatigue will be assessed by using Fatigue Severity Scale. It includes nine items, and each item is scored between 1-7 (1: totally disagree, 7: totally agree). Higher scores indicate higher levels of fatigue.
measure: Change in total body mass
time frame: At baseline and 8 weeks later
description: Total body mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.
measure: Change in fat mass
time frame: At baseline and 8 weeks later
description: Fat mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.
measure: Change in fat free muscle mass
time frame: At baseline and 8 weeks later
description: Fat free muscle mass will be measured by using bioelectrical impedance analysis and will be recorded in kilograms.
measure: Change in basal metabolism rate
time frame: At baseline and 8 weeks later
description: Basal metabolism will be measured by analyzing gas exchange in rest position. Oxygen consumption and carbon dioxide production will be recorded.
arm group label: Deep Water Running
arm group type: Experimental
description: Participants in this group will perform running in a vertical position in water. The sessions will be held in deep pool where the feet of the participants will not touch the ground.
arm group label: Treadmill Running
arm group type: Active Comparator
description: Participants in this group will perform running on a treadmill.
arm group label: Control
arm group type: No Intervention
description: Participants in this group will not interfere regular exercise for 8 weeks.
intervention type: Other
intervention name: Exercise
description: Exercise sessions will include 10 minutes of warming up, 30 minutes of loading, and 10 minutes of cooling down. The exercises will be performed two times in a week for eight weeks.
arm group label: Deep Water Running
arm group label: Treadmill Running
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deniz Bayraktar, PhD
phone: +90 232 329 35 35
phone ext: 4833
email: ptdenislav@yahoo.com
facility: 
contact: 
country: Turkey
citation: Kelly BT, Roskin LA, Kirkendall DT, Speer KP. Shoulder muscle activation during aquatic and dry land exercises in nonimpaired subjects. J Orthop Sports Phys Ther. 2000 Apr;30(4):204-10. doi: 10.2519/jospt.2000.30.4.204.
PMID: 10778797
citation: Reichert T, Kanitz AC, Delevatti RS, Bagatini NC, Barroso BM, Kruel LF. Continuous and interval training programs using deep water running improves functional fitness and blood pressure in the older adults. Age (Dordr). 2016 Feb;38(1):20. doi: 10.1007/s11357-016-9882-5. Epub 2016 Feb 3.
PMID: 26841888
citation: Cuesta-Vargas AI, Buchan J, Arroyo-Morales M. A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. Eur J Cancer Care (Engl). 2014 Jan;23(1):15-21. doi: 10.1111/ecc.12114. Epub 2013 Aug 16.
PMID: 23947581
citation: Cuesta-Vargas AI, Adams N, Salazar JA, Belles A, Hazanas S, Arroyo-Morales M. Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial. Clin Rheumatol. 2012 Jul;31(7):1073-8. doi: 10.1007/s10067-012-1977-5. Epub 2012 Mar 29.
PMID: 22453844
citation: Wilber RL, Moffatt RJ, Scott BE, Lee DT, Cucuzzo NA. Influence of water run training on the maintenance of aerobic performance. Med Sci Sports Exerc. 1996 Aug;28(8):1056-62. doi: 10.1097/00005768-199608000-00017.
PMID: 8871917
citation: Broman G, Quintana M, Lindberg T, Jansson E, Kaijser L. High intensity deep water training can improve aerobic power in elderly women. Eur J Appl Physiol. 2006 Sep;98(2):117-23. doi: 10.1007/s00421-006-0237-2. Epub 2006 Aug 22.
PMID: 16924529
citation: Bayraktar D, Savci S, Altug-Gucenmez O, Manci E, Makay B, Ilcin N, Unsal E. The effects of 8-week water-running program on exercise capacity in children with juvenile idiopathic arthritis: a controlled trial. Rheumatol Int. 2019 Jan;39(1):59-65. doi: 10.1007/s00296-018-4209-8. Epub 2018 Nov 14.
PMID: 30430201
citation: Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.
PMID: 3324256
citation: Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.
PMID: 9014953
citation: Raya MA, Gailey RS, Gaunaurd IA, Jayne DM, Campbell SM, Gagne E, Manrique PG, Muller DG, Tucker C. Comparison of three agility tests with male servicemembers: Edgren Side Step Test, T-Test, and Illinois Agility Test. J Rehabil Res Dev. 2013;50(7):951-60. doi: 10.1682/JRRD.2012.05.0096.
PMID: 24301432
citation: McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
PMID: 10453772
citation: Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
PMID: 17293726
citation: Jebb SA, Cole TJ, Doman D, Murgatroyd PR, Prentice AM. Evaluation of the novel Tanita body-fat analyser to measure body composition by comparison with a four-compartment model. Br J Nutr. 2000 Feb;83(2):115-22. doi: 10.1017/s0007114500000155.
PMID: 10743490
citation: Vandarakis D, Salacinski AJ, Broeder CE. A comparison of COSMED metabolic systems for the determination of resting metabolic rate. Res Sports Med. 2013;21(2):187-94. doi: 10.1080/15438627.2012.757226.
PMID: 23541105
responsible party type: Principal Investigator
investigator affiliation: Izmir Katip Celebi University
investigator full name: Deniz Bayraktar
investigator title: Assistant Professor
sharing ipd: No