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

NCT ID: NCT02911987

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-09-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

the 'cardio' HIT group

Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group).

Group Type: EXPERIMENTAL

high intensity training (HIT) program

Intervention Type: OTHER

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.

the 'general' HIT group

Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ).

Group Type: EXPERIMENTAL

high intensity training (HIT) program

Intervention Type: OTHER

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.

the 'lumbar' HIT group

Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group).

Group Type: EXPERIMENTAL

high intensity training (HIT) program

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

high intensity training (HIT) program

Intervention Type: OTHER

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.

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)

Group Type: ACTIVE_COMPARATOR

moderate intensity training (MIT) exercise therapy

Intervention Type: OTHER

MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility 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. -

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Annick Timmermans

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annick Timmermans, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Frank Vandenabeele, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Hasselt University

Hasselt, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jonas Verbrugghe, drs.

Role: CONTACT

jonas.verbrugghe@uhasselt.be

+ 32 11 26 92 39

Anouk Agten, drs.

Role: CONTACT

anouk.agten@uhasselt.be

Facility Contacts

Jonas Verbrugghe, drs.

Role: primary

jonas.verbrugghe@uhasselt.be

Other Identifiers

LBP-HIT-RCT

Identifier Type: -

Identifier Source: org_study_id