<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/NCT03753165</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-PGS-2018-01-076</org_study_id>
    <nct_id>NCT03753165</nct_id>
  </id_info>
  <brief_title>Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients</brief_title>
  <acronym>CLBP</acronym>
  <official_title>Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imam Abdulrahman Bin Faisal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imam Abdulrahman Bin Faisal 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>
      Patients with low back pain (LBP) often report an overall reduced physical activity and&#xD;
      fitness that could consequently lead to an altered autonomic balance. Dysregulation of&#xD;
      autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation&#xD;
      and persistence of chronic muscle pain.High intensity interval exercise (HIIE) is a newer&#xD;
      modality where short bursts of high intensity exercise are interspersed with rest intervals.&#xD;
&#xD;
      Method:Study Design: It is a single blinded randomised clinical trial.Sample Size:&#xD;
&#xD;
      Experimental Group (HIIE+ standard regular physiotherapy) = 40 Positive Control Group&#xD;
      (standard regular physiotherapy) = 40 After the ethical approval of Imam Abdulrahman Bin&#xD;
      Faisal University, Dammam, eighty (80) patients with nonspecific CLBP (either sex, age range&#xD;
      18-65 years years) will be recruited. These patients, with mild to moderate disability/pain&#xD;
      according to Oswestry index, will be referred from the orthopedics clinic, rheumatologist,&#xD;
      neurology, rehabilitation specialist, to the physiotherapy department.&#xD;
&#xD;
      Oswestry Disability Index (ODI) will be completed for all CLBP patients. Pre and post&#xD;
      assessment includes pain intensity, disability, resting heart rate (HRrest) and blood&#xD;
      pressure, maximum heart rate (HRmax) after graded maximal exercise, heart rate recovery after&#xD;
      graded maximal exercise (HRR).&#xD;
&#xD;
      Tests of autonomic function will be done by recording ECG and analyzing he ECG for&#xD;
      variability in heart rate (HRV), the Expiratory/inspiratory ratio in deep breathing (HRVdb)&#xD;
      and baroreceptor sensitivity (BRS) at rest. Additionally each subject will be exposed to an&#xD;
      orthostatic challenge and his responses will be evaluated. The recording will be done first&#xD;
      in supine position and then asking the patient to quickly stand up and remain standing for 5&#xD;
      min. Data will be entered in Microsoft excel and comparisons and correlations will be done&#xD;
      using either excel or SPSS version 20.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effect of High Intensity Interval Exercise on pain, disability and autonomic balance in&#xD;
      patients with chronic low back pain&#xD;
&#xD;
      Chronic low back pain (CLBP) is a clinical problem of large magnitude with great&#xD;
      socio-economical effect. About 80% of people may complain of low back pain in their life.&#xD;
&#xD;
      Patients with low back pain (LBP) often report an overall reduced physical activity and&#xD;
      fitness that could consequently lead to an altered autonomic balance. Dysregulation of&#xD;
      autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation&#xD;
      and persistence of chronic muscle pain. Different types of exercises can be prescribed to&#xD;
      patients with CLBP to improve pain, disability and physical fitness. High intensity interval&#xD;
      exercise (HIIE) is a newer modality where short bursts of high intensity exercise are&#xD;
      interspersed with rest intervals.it is more time efficient, enjoyable, and superior to mild&#xD;
      or moderate intensity continuous exercise in improving the physical fitness, peak&#xD;
      performance, autonomic balance, muscle strength and coordination in athletes. HIIE might&#xD;
      prove more useful and effective for individuals with nonspecific CLBP and could have a better&#xD;
      adherence rate in the long run.&#xD;
&#xD;
      Methods: After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, KSA,&#xD;
      eighty (80) patients with nonspecific CLBP (either sex, age: 18-65 years) will be recruited.&#xD;
      These patients, with mild to moderate disability/pain according to Oswestry index, will be&#xD;
      referred from relevant clinics to the physiotherapy department of King Fahd Hospital of the&#xD;
      University, AlKhobar (KFHU). After full explanation of the study, the patients will be&#xD;
      required to sign an informed consent form and then they will be randomly assigned to one of&#xD;
      the two groups.&#xD;
&#xD;
      Experimental Group (GE: n= 40) will be assigned for HIIE in addition to standard regular&#xD;
      physiotherapy, and Control Group (GC: n=40) will be designated as control group with standard&#xD;
      regular physiotherapy only. Pre and post intervention assessment includes pain intensity&#xD;
      through Numerical Pain Scale, disability through Oswestry Disability Index (ODI) and&#xD;
      autonomic balance through heart rate variability (HRV) and baroreflex sensitivity (BRS) at&#xD;
      rest and in response to an orthostatic challenge.&#xD;
&#xD;
      Data will be entered in Microsoft excel and comparisons and correlations will be done using&#xD;
      either excel or SPSS version 20 Expectations: It is expected that HIIE will improve the&#xD;
      autonomic balance of the CLBP patients to a greater extent compared to no-exercise and&#xD;
      consequently improve the pain and disability to a higher degree. HIIE could be a useful,&#xD;
      efficacious addition to the list of exercise modalities for patients with nonspecific CLBP,&#xD;
      and could be recommended for management of appropriate group of CLBP patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>It is a single blinded randomised clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in heart rate variability</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Recovery</measure>
    <time_frame>baseline and after 6 weeks</time_frame>
    <description>Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical pain scale</measure>
    <time_frame>baseline and after 6 weeks</time_frame>
    <description>Measurement of pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>baseline and after 6 weeks</time_frame>
    <description>Questionnaire to assess the disability in patients with chronic low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baroreceptor Sensitivity (BRS)</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from chronic low back pain perform 12 sessions of high intensity interval exercise (HIIE) over a period of 6 weeks at an intensity of 80% of their maximal Heart rate. In addition they also receive conventional physiotherapy in the form of hot pack or TENS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional physiotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients suffering from chronic low back pain will receive conventional physiotherapy such as TENS and hot packs applied over appropriate areas over a period of 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity interval exercise</intervention_name>
    <description>High intensity interval exercise at 80% of the maximal heart rate derived from the maximal graded exercise. Each individual will undergo 12 sessions of HIIE over a period of six weeks</description>
    <arm_group_label>High Intensity Interval Exercise group</arm_group_label>
    <other_name>Conventional physiotherapy- Hot packs, TENS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 18-65 years.&#xD;
&#xD;
          -  BMI 18.5 - 34.9 kg/m2.&#xD;
&#xD;
          -  Diagnosed patients as non-specific chronic low back pain patients, referred by&#xD;
             orthopedic specialist, rheumatologist, rehabilitation specialist to physical therapy.&#xD;
&#xD;
          -  Oswestry Disability Index (ODI): mild to moderate .&#xD;
&#xD;
          -  The subjects should be able to understand, communicate and perform the examination and&#xD;
             can walk without any walking aids.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Walking with using any walking aids.&#xD;
&#xD;
          -  Subjects with secondary LBP, Sciatica, Osteoporosis, Osteoarthritis, generalized&#xD;
             neuromuscular problem or any deformity.&#xD;
&#xD;
          -  Any diagnosed disease likely to interfere with exercise on bicycle ergometer or safety&#xD;
             of the subject (especially cardiac or respiratory disease.&#xD;
&#xD;
          -  Patients with known diabetic autonomic complications&#xD;
&#xD;
          -  Persons taking medicines that are known to interfere with HRV variables, such as beta&#xD;
             blockers, calcium antagonists.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Fahd Hospital of the University</name>
      <address>
        <city>Khobar</city>
        <state>Eastren</state>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.</citation>
    <PMID>24787228</PMID>
  </reference>
  <reference>
    <citation>Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.</citation>
    <PMID>8737210</PMID>
  </reference>
  <reference>
    <citation>Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.</citation>
    <PMID>23539308</PMID>
  </reference>
  <reference>
    <citation>Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.</citation>
    <PMID>10536127</PMID>
  </reference>
  <reference>
    <citation>Dupuy O, Mekary S, Berryman N, Bherer L, Audiffren M, Bosquet L. Reliability of heart rate measures used to assess post-exercise parasympathetic reactivation. Clin Physiol Funct Imaging. 2012 Jul;32(4):296-304. doi: 10.1111/j.1475-097X.2012.01125.x. Epub 2012 Feb 23.</citation>
    <PMID>22681607</PMID>
  </reference>
  <reference>
    <citation>Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.</citation>
    <PMID>26489022</PMID>
  </reference>
  <reference>
    <citation>Fairbank J. Use of Oswestry Disability Index (ODI). Spine (Phila Pa 1976). 1995 Jul 1;20(13):1535-7. No abstract available.</citation>
    <PMID>8623078</PMID>
  </reference>
  <reference>
    <citation>Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.</citation>
    <PMID>23877260</PMID>
  </reference>
  <reference>
    <citation>Freeman R, Chapleau MW. Testing the autonomic nervous system. Handb Clin Neurol. 2013;115:115-36. doi: 10.1016/B978-0-444-52902-2.00007-2.</citation>
    <PMID>23931777</PMID>
  </reference>
  <reference>
    <citation>Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.</citation>
    <PMID>22289907</PMID>
  </reference>
  <reference>
    <citation>Hallman DM, Ekman AH, Lyskov E. Changes in physical activity and heart rate variability in chronic neck-shoulder pain: monitoring during work and leisure time. Int Arch Occup Environ Health. 2014;87(7):735-44. doi: 10.1007/s00420-013-0917-2. Epub 2013 Oct 26.</citation>
    <PMID>24162088</PMID>
  </reference>
  <reference>
    <citation>Iellamo F, Manzi V, Caminiti G, Sposato B, Massaro M, Cerrito A, Rosano G, Volterrani M. Dose-response relationship of baroreflex sensitivity and heart rate variability to individually-tailored exercise training in patients with heart failure. Int J Cardiol. 2013 Jun 20;166(2):334-9. doi: 10.1016/j.ijcard.2011.10.082. Epub 2011 Nov 9.</citation>
    <PMID>22078985</PMID>
  </reference>
  <reference>
    <citation>Jung ME, Bourne JE, Beauchamp MR, Robinson E, Little JP. High-intensity interval training as an efficacious alternative to moderate-intensity continuous training for adults with prediabetes. J Diabetes Res. 2015;2015:191595. doi: 10.1155/2015/191595. Epub 2015 Mar 30.</citation>
    <PMID>25918728</PMID>
  </reference>
  <reference>
    <citation>La Rovere MT, Pinna GD, Maestri R, Sleight P. Clinical value of baroreflex sensitivity. Neth Heart J. 2013 Feb;21(2):61-3. doi: 10.1007/s12471-012-0349-8.</citation>
    <PMID>23184601</PMID>
  </reference>
  <reference>
    <citation>Perini R, Veicsteinas A. Heart rate variability and autonomic activity at rest and during exercise in various physiological conditions. Eur J Appl Physiol. 2003 Oct;90(3-4):317-25. doi: 10.1007/s00421-003-0953-9. Epub 2003 Sep 12.</citation>
    <PMID>13680241</PMID>
  </reference>
  <reference>
    <citation>Pinna GD, Maestri R, La Rovere MT. Assessment of baroreflex sensitivity from spontaneous oscillations of blood pressure and heart rate: proven clinical value? Physiol Meas. 2015 Apr;36(4):741-53. doi: 10.1088/0967-3334/36/4/741. Epub 2015 Mar 23.</citation>
    <PMID>25798657</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Imam Abdulrahman Bin Faisal University</investigator_affiliation>
    <investigator_full_name>Haya Mohammad ALMaawi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic low back pain, Heart rate variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No there is no plan to make the IPD available</ipd_description>
  </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/NCT03753165
org study id: IRB-PGS-2018-01-076
nct id: NCT03753165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with low back pain (LBP) often report an overall reduced physical activity and
      fitness that could consequently lead to an altered autonomic balance. Dysregulation of
      autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation
      and persistence of chronic muscle pain.High intensity interval exercise (HIIE) is a newer
      modality where short bursts of high intensity exercise are interspersed with rest intervals.

      Method:Study Design: It is a single blinded randomised clinical trial.Sample Size:

      Experimental Group (HIIE+ standard regular physiotherapy) = 40 Positive Control Group
      (standard regular physiotherapy) = 40 After the ethical approval of Imam Abdulrahman Bin
      Faisal University, Dammam, eighty (80) patients with nonspecific CLBP (either sex, age range
      18-65 years years) will be recruited. These patients, with mild to moderate disability/pain
      according to Oswestry index, will be referred from the orthopedics clinic, rheumatologist,
      neurology, rehabilitation specialist, to the physiotherapy department.

      Oswestry Disability Index (ODI) will be completed for all CLBP patients. Pre and post
      assessment includes pain intensity, disability, resting heart rate (HRrest) and blood
      pressure, maximum heart rate (HRmax) after graded maximal exercise, heart rate recovery after
      graded maximal exercise (HRR).

      Tests of autonomic function will be done by recording ECG and analyzing he ECG for
      variability in heart rate (HRV), the Expiratory/inspiratory ratio in deep breathing (HRVdb)
      and baroreceptor sensitivity (BRS) at rest. Additionally each subject will be exposed to an
      orthostatic challenge and his responses will be evaluated. The recording will be done first
      in supine position and then asking the patient to quickly stand up and remain standing for 5
      min. Data will be entered in Microsoft excel and comparisons and correlations will be done
      using either excel or SPSS version 20.
Effect of High Intensity Interval Exercise on pain, disability and autonomic balance in
      patients with chronic low back pain

      Chronic low back pain (CLBP) is a clinical problem of large magnitude with great
      socio-economical effect. About 80% of people may complain of low back pain in their life.

      Patients with low back pain (LBP) often report an overall reduced physical activity and
      fitness that could consequently lead to an altered autonomic balance. Dysregulation of
      autonomic nervous system (ANS) is also implicated to be an underlying cause in the initiation
      and persistence of chronic muscle pain. Different types of exercises can be prescribed to
      patients with CLBP to improve pain, disability and physical fitness. High intensity interval
      exercise (HIIE) is a newer modality where short bursts of high intensity exercise are
      interspersed with rest intervals.it is more time efficient, enjoyable, and superior to mild
      or moderate intensity continuous exercise in improving the physical fitness, peak
      performance, autonomic balance, muscle strength and coordination in athletes. HIIE might
      prove more useful and effective for individuals with nonspecific CLBP and could have a better
      adherence rate in the long run.

      Methods: After the ethical approval of Imam Abdulrahman Bin Faisal University, Dammam, KSA,
      eighty (80) patients with nonspecific CLBP (either sex, age: 18-65 years) will be recruited.
      These patients, with mild to moderate disability/pain according to Oswestry index, will be
      referred from relevant clinics to the physiotherapy department of King Fahd Hospital of the
      University, AlKhobar (KFHU). After full explanation of the study, the patients will be
      required to sign an informed consent form and then they will be randomly assigned to one of
      the two groups.

      Experimental Group (GE: n= 40) will be assigned for HIIE in addition to standard regular
      physiotherapy, and Control Group (GC: n=40) will be designated as control group with standard
      regular physiotherapy only. Pre and post intervention assessment includes pain intensity
      through Numerical Pain Scale, disability through Oswestry Disability Index (ODI) and
      autonomic balance through heart rate variability (HRV) and baroreflex sensitivity (BRS) at
      rest and in response to an orthostatic challenge.

      Data will be entered in Microsoft excel and comparisons and correlations will be done using
      either excel or SPSS version 20 Expectations: It is expected that HIIE will improve the
      autonomic balance of the CLBP patients to a greater extent compared to no-exercise and
      consequently improve the pain and disability to a higher degree. HIIE could be a useful,
      efficacious addition to the list of exercise modalities for patients with nonspecific CLBP,
      and could be recommended for management of appropriate group of CLBP patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It is a single blinded randomised clinical trial
primary purpose: Treatment
masking: Single (Participant)
measure: Change in heart rate variability
time frame: baseline and 6 weeks
description: heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF
measure: Heart Rate Recovery
time frame: baseline and after 6 weeks
description: Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise
measure: Numerical pain scale
time frame: baseline and after 6 weeks
description: Measurement of pain intensity
measure: Oswestry Disability Index
time frame: baseline and after 6 weeks
description: Questionnaire to assess the disability in patients with chronic low back pain
measure: Baroreceptor Sensitivity (BRS)
time frame: baseline and 6 weeks
description: recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS
arm group label: High Intensity Interval Exercise group
arm group type: Experimental
description: Patients suffering from chronic low back pain perform 12 sessions of high intensity interval exercise (HIIE) over a period of 6 weeks at an intensity of 80% of their maximal Heart rate. In addition they also receive conventional physiotherapy in the form of hot pack or TENS
arm group label: Conventional physiotherapy
arm group type: No Intervention
description: Patients suffering from chronic low back pain will receive conventional physiotherapy such as TENS and hot packs applied over appropriate areas over a period of 6 weeks
intervention type: Other
intervention name: High intensity interval exercise
description: High intensity interval exercise at 80% of the maximal heart rate derived from the maximal graded exercise. Each individual will undergo 12 sessions of HIIE over a period of six weeks
arm group label: High Intensity Interval Exercise group
other name: Conventional physiotherapy- Hot packs, TENS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
citation: Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.
PMID: 24787228
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
PMID: 8737210
citation: Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
PMID: 23539308
citation: Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.
PMID: 10536127
citation: Dupuy O, Mekary S, Berryman N, Bherer L, Audiffren M, Bosquet L. Reliability of heart rate measures used to assess post-exercise parasympathetic reactivation. Clin Physiol Funct Imaging. 2012 Jul;32(4):296-304. doi: 10.1111/j.1475-097X.2012.01125.x. Epub 2012 Feb 23.
PMID: 22681607
citation: Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015.
PMID: 26489022
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responsible party type: Principal Investigator
investigator affiliation: Imam Abdulrahman Bin Faisal University
investigator full name: Haya Mohammad ALMaawi
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
ipd description: No there is no plan to make the IPD available