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Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients (CLBP)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
High intensity interval exercise
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Heart rate variability

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range 18-65 years.
  • BMI 18.5 - 34.9 kg/m2.
  • Diagnosed patients as non-specific chronic low back pain patients, referred by orthopedic specialist, rheumatologist, rehabilitation specialist to physical therapy.
  • Oswestry Disability Index (ODI): mild to moderate .
  • The subjects should be able to understand, communicate and perform the examination and can walk without any walking aids.

Exclusion Criteria:

  • Walking with using any walking aids.
  • Subjects with secondary LBP, Sciatica, Osteoporosis, Osteoarthritis, generalized neuromuscular problem or any deformity.
  • Any diagnosed disease likely to interfere with exercise on bicycle ergometer or safety of the subject (especially cardiac or respiratory disease.
  • Patients with known diabetic autonomic complications
  • Persons taking medicines that are known to interfere with HRV variables, such as beta blockers, calcium antagonists.
  • Pregnancy or lactation.

Sites / Locations

  • King Fahd Hospital of the University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High Intensity Interval Exercise group

Conventional physiotherapy

Arm 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

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

Outcomes

Primary Outcome Measures

Change in heart rate variability
heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF

Secondary Outcome Measures

Heart Rate Recovery
Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise
Numerical pain scale
Measurement of pain intensity
Oswestry Disability Index
Questionnaire to assess the disability in patients with chronic low back pain
Baroreceptor Sensitivity (BRS)
recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS

Full Information

First Posted
November 21, 2018
Last Updated
March 27, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT03753165
Brief Title
Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients
Acronym
CLBP
Official Title
Effect of High Intensity Interval Exercise on Pain,Disability, and Autonomic Nervous System on Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain, Heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a single blinded randomised clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Exercise group
Arm Type
Experimental
Arm 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 Title
Conventional physiotherapy
Arm Type
No Intervention
Arm 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(s)
High intensity interval exercise
Other Intervention Name(s)
Conventional physiotherapy- Hot packs, TENS
Intervention 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
Primary Outcome Measure Information:
Title
Change in heart rate variability
Description
heart rate variability parameters including SDNN, RMSSD, LF, HF, LH/HF
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Heart Rate Recovery
Description
Heart rate recovery from the peak rate at 1st, 2nd and 3rd minute after cessation of heavy exercise
Time Frame
baseline and after 6 weeks
Title
Numerical pain scale
Description
Measurement of pain intensity
Time Frame
baseline and after 6 weeks
Title
Oswestry Disability Index
Description
Questionnaire to assess the disability in patients with chronic low back pain
Time Frame
baseline and after 6 weeks
Title
Baroreceptor Sensitivity (BRS)
Description
recording of finger arterial blood pressure and interbeat interval with finometer and calculating the baroreceptor sensitivity with dedicated software PRVBRS
Time Frame
baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 18-65 years. BMI 18.5 - 34.9 kg/m2. Diagnosed patients as non-specific chronic low back pain patients, referred by orthopedic specialist, rheumatologist, rehabilitation specialist to physical therapy. Oswestry Disability Index (ODI): mild to moderate . The subjects should be able to understand, communicate and perform the examination and can walk without any walking aids. Exclusion Criteria: Walking with using any walking aids. Subjects with secondary LBP, Sciatica, Osteoporosis, Osteoarthritis, generalized neuromuscular problem or any deformity. Any diagnosed disease likely to interfere with exercise on bicycle ergometer or safety of the subject (especially cardiac or respiratory disease. Patients with known diabetic autonomic complications Persons taking medicines that are known to interfere with HRV variables, such as beta blockers, calcium antagonists. Pregnancy or lactation.
Facility Information:
Facility Name
King Fahd Hospital of the University
City
Khobar
State/Province
Eastren
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No there is no plan to make the IPD available
Citations:
PubMed Identifier
24787228
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.
Results Reference
background
PubMed Identifier
8737210
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.
Results Reference
background
PubMed Identifier
23539308
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.
Results Reference
background
PubMed Identifier
10536127
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.
Results Reference
background
PubMed Identifier
22681607
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.
Results Reference
background
PubMed Identifier
26489022
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.
Results Reference
background
PubMed Identifier
8623078
Citation
Fairbank J. Use of Oswestry Disability Index (ODI). Spine (Phila Pa 1976). 1995 Jul 1;20(13):1535-7. No abstract available.
Results Reference
background
PubMed Identifier
23877260
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.
Results Reference
background
PubMed Identifier
23931777
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.
Results Reference
background
PubMed Identifier
22289907
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.
Results Reference
background
PubMed Identifier
24162088
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.
Results Reference
background
PubMed Identifier
22078985
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.
Results Reference
background
PubMed Identifier
25918728
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.
Results Reference
background
PubMed Identifier
23184601
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.
Results Reference
background
PubMed Identifier
13680241
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.
Results Reference
background
PubMed Identifier
25798657
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.
Results Reference
background

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Effect of High Intensity Interval Exercise on Chronic Low Back Pain Patients

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