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Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain (LBP-HIT-RCT)

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ClinicalTrials.gov Identifier: NCT02911987
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Annick Timmermans, Hasselt University

Brief Summary:

Low back pain is a common disorder, occurring worldwide in both males and females in all age groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).

Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.

Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.

The aim of this randomized clinical trial study is to evaluate the effects of a HIT program on disease related outcomes, physical fitness and muscle contractile characteristics compared to a conventional rehabilitation program in persons with NSCLBP.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: high intensity training (HIT) program Other: moderate intensity training (MIT) exercise therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the 'cardio' HIT group
Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group).
Other: high intensity training (HIT) program
The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.

Experimental: the 'general' HIT group
Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ).
Other: high intensity training (HIT) program
The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.

Experimental: the 'lumbar' HIT group
Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group).
Other: high intensity training (HIT) program
The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.

Experimental: the 'combined' HIT group
Group 4 receives HIT exercise which is a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'combined' HIT group). These trainings will take place in the REVAL Rehabilitation Research Center on the campus of Hasselt University in Diepenbeek.
Other: high intensity training (HIT) program
The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.

Active Comparator: control group
Group 5 receives MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group)
Other: moderate intensity training (MIT) exercise therapy
MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group).




Primary Outcome Measures :
  1. pain [ Time Frame: day 1 ]
    The Numeric Pain Rating Scale (NPRS) is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant.

  2. pain [ Time Frame: week 6 ]
    The Numeric Pain Rating Scale (NPRS)

  3. pain [ Time Frame: week 12 ]
    The Numeric Pain Rating Scale (NPRS)

  4. Kinesiophobia [ Time Frame: day 1 ]
    The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.

  5. Kinesiophobia [ Time Frame: week 6 ]
    The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.

  6. Kinesiophobia [ Time Frame: week 12 ]
    The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.

  7. Physical disability RMDQ [ Time Frame: day 1 ]
    The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.

  8. Physical disability RMDQ [ Time Frame: week 6 ]
    The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.

  9. Physical disability RMDQ [ Time Frame: week 12 ]
    The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.

  10. Endurance capacity [ Time Frame: day 1 ]
    Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer

  11. Endurance capacity [ Time Frame: week 6 ]
    Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer

  12. Endurance capacity [ Time Frame: week 12 ]
    Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer

  13. Abdominal/back strength [ Time Frame: day 1 ]
    The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

  14. Abdominal/back strength [ Time Frame: week 6 ]
    The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

  15. Abdominal/back strength [ Time Frame: week 12 ]
    The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

  16. Muscle Biopsy [ Time Frame: day 1 ]

    muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.).

    Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.


  17. Muscle Biopsy [ Time Frame: week 12 ]

    muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.).

    Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.


  18. Physical disability ODI [ Time Frame: day 1 ]
    The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.

  19. Physical disability ODI [ Time Frame: week 6 ]
    The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.

  20. Physical disability ODI [ Time Frame: week 12 ]
    The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.

  21. activity level [ Time Frame: day 1 ]
    Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.

  22. activity level [ Time Frame: week 6 ]
    Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.

  23. activity level [ Time Frame: week 12 ]
    Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: day 1 ]
    The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.

  2. Body composition [ Time Frame: week 6 ]
    The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.

  3. Body composition [ Time Frame: week 12 ]
    The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.

  4. physical activity tracking [ Time Frame: day 1 ]
    Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary).

  5. physical activity tracking [ Time Frame: week 12 ]
    Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary).

  6. disability in participation and quality of life [ Time Frame: day 1 ]
    Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.

  7. disability in participation and quality of life [ Time Frame: week 6 ]
    Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.

  8. disability in participation and quality of life [ Time Frame: week 12 ]
    Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.

  9. Motivation VAS [ Time Frame: day 1 ]
    The start motivation is measured by a visual analog scale (VAS).

  10. Motivation IMI [ Time Frame: day 1 ]
    At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).

  11. Motivation VAS [ Time Frame: week 6 ]
    The start motivation is measured by a visual analog scale (VAS).

  12. Motivation IMI [ Time Frame: week 6 ]
    At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).

  13. Motivation VAS [ Time Frame: week 12 ]
    The start motivation is measured by a visual analog scale (VAS).

  14. Motivation IMI [ Time Frame: week 12 ]
    At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. medically diagnosed with non-specific chronic low back pain,
  2. over 25 years old,
  3. Oswestry Disability Index: disability score >20%,
  4. able to understand Dutch (spoken and written),
  5. Physical Activities Scale For Individuals with Physical Disabilities <30. -

Exclusion Criteria:

  1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
  2. radiculopathy (uni- or bilateral),
  3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
  4. ongoing compensation claims and/or (work)disability > 6 months,
  5. rehabilitation/exercise therapy program for LBP in the past 6 months. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911987


Contacts
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Contact: Jonas Verbrugghe, drs. + 32 11 26 92 39 jonas.verbrugghe@uhasselt.be
Contact: Anouk Agten, drs. anouk.agten@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Hasselt, Belgium, B-3500
Contact: Jonas Verbrugghe, drs.       jonas.verbrugghe@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Annick Timmermans, prof. dr. Hasselt University
Principal Investigator: Frank Vandenabeele, prof. dr. Hasselt University

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Responsible Party: Annick Timmermans, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02911987     History of Changes
Other Study ID Numbers: LBP-HIT-RCT
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms