Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Endurance capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically diagnosed with non-specific chronic low back pain,
- •over 25 years old,
- •Oswestry Disability Index: disability score >20%,
- •able to understand Dutch (spoken and written),
- •Physical Activities Scale For Individuals with Physical Disabilities <
排除标准
- •invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
- •radiculopathy (uni- or bilateral),
- •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,
- •ongoing compensation claims and/or (work)disability > 6 months,
- •rehabilitation/exercise therapy program for LBP in the past 6 months. -
研究组 & 干预措施
the 'cardio' HIT group
Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group).
干预措施: high intensity training (HIT) program (Other)
the 'general' HIT group
Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ).
干预措施: high intensity training (HIT) program (Other)
the 'lumbar' HIT group
Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group).
干预措施: high intensity training (HIT) program (Other)
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.
干预措施: high intensity training (HIT) program (Other)
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)
干预措施: moderate intensity training (MIT) exercise therapy (Other)
结局指标
主要结局
Endurance capacity
时间窗: week 12
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Muscle Biopsy
时间窗: 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.
Physical disability ODI
时间窗: 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.
pain
时间窗: week 12
The Numeric Pain Rating Scale (NPRS)
Physical disability RMDQ
时间窗: 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.
Kinesiophobia
时间窗: 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.
Abdominal/back strength
时间窗: 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).
activity level
时间窗: 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.
次要结局
- Body composition(week 12)
- physical activity tracking(week 12)
- disability in participation and quality of life(week 12)
- Motivation VAS(week 12)
- Motivation IMI(week 12)
研究者
Annick Timmermans
prof. dr.
Hasselt University