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

Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: high intensity training (HIT) program; Other: moderate intensity training (MIT) exercise therapy

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonas Verbrugghe, drs.; Phone Number: + 32 11 26 92 39; Email: jonas.verbrugghe@uhasselt.be
• Study Contact Backup: Name: Anouk Agten, drs.; Email: anouk.agten@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, B-3500
    • Recruiting
    • Hasselt University
    • Contact: Jonas Verbrugghe, drs.; Email: jonas.verbrugghe@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	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.	day 1
pain	The Numeric Pain Rating Scale (NPRS)	week 6
pain	The Numeric Pain Rating Scale (NPRS)	week 12
Kinesiophobia	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.	day 1
Kinesiophobia	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.	week 6
Kinesiophobia	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.	week 12
Physical disability RMDQ	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.	day 1
Physical disability RMDQ	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.	week 6
Physical disability RMDQ	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.	week 12
Endurance capacity	Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer	day 1
Endurance capacity	Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer	week 6
Endurance capacity	Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer	week 12
Abdominal/back strength	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).	day 1
Abdominal/back strength	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).	week 6
Abdominal/back strength	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).	week 12
Muscle Biopsy	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.	day 1
Muscle Biopsy	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.	week 12
Physical disability ODI	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.	day 1
Physical disability ODI	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.	week 6
Physical disability ODI	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.	week 12
activity level	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.	day 1
activity level	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.	week 6
activity level	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.	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.	day 1
Body composition	The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.	week 6
Body composition	The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.	week 12
physical activity tracking	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).	day 1
physical activity tracking	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).	week 12
disability in participation and quality of life	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.	day 1
disability in participation and quality of life	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.	week 6
disability in participation and quality of life	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.	week 12
Motivation VAS	The start motivation is measured by a visual analog scale (VAS).	day 1
Motivation IMI	At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).	day 1
Motivation VAS	The start motivation is measured by a visual analog scale (VAS).	week 6
Motivation IMI	At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).	week 6
Motivation VAS	The start motivation is measured by a visual analog scale (VAS).	week 12
Motivation IMI	At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).	week 12

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Principal Investigator: Frank Vandenabeele, prof. dr., Hasselt University; Principal Investigator: Annick Timmermans, prof. dr., Hasselt University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP-HIT-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED