The Breathe-(H)IT Trial: Multimodal High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Diaphragm activation (timing)
研究概览
简要总结
This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory fitness, postural control, pain and disability after HIT versus MIT, 3) to which extent depressive mood and anxiety moderate the effects of HIT on diaphragm functioning in persons with chronic nonspecific low back pain (CNSLBP). The investigators hypothize that HIT improves diaphragm functioning more compared to MIT in persons with CNSLBP.
详细描述
Low back pain is the number one cause of disability worldwide with important socio-economic implications. In Belgium, 7 out of 10 persons will suffer from low back pain during their life, and 29% of all sick leave days are due to it. Chronic low back pain is defined as persistent pain for a period of minimal 12 weeks. In 85-90% of the CLBP cases, the pain cannot be attributed to a definitive underlying pathoanatomical cause, and is therefore labelled as chronic nonspecific low back pain (CNSLBP).
International guidelines recommend exercise therapy as the first-choice treatment for CNSLBP. A crucial factor within this context is exercise intensity. Indeed, multimodal high intensity training (HIT) leads to higher improvements in disability and cardiorespiratory fitness compared to moderate intensity training (MIT) in persons with CNSLBP. However, the underlying mechanisms for the additional value of a HIT approach remain largely unknown. Interestingly, low back pain is associated with impairments in diaphragm function, as the diaphragm is not only a principal inspiratory muscle, but also plays an essential role in postural control. The latter is a key factor in the development and maintenance of CNSLBP.
In this randomized controlled trial, 64 persons with CNSLBP will be recruited through local distribution of flyers and adverts on social media. The sample size calculation is based on (1) the therapeutic effects of a 12-week HIT program (compared to a MIT program) on the maximal oxygen uptake (VO2max) in persons with CNSLBP and (2) the therapeutic effects of a 8-week high-intensity inspiratory muscle training program (compared to a low-intensity inspiratory muscle training program) on the maximal inspiratory pressure (MIP) in persons with CNSLBP. These outcomes were chosen as they relate to the respiratory system and are thus most fitting to indicate possible effects on diaphragm functioning. The sample size calculation is based on the requirement of a minimal clinically important difference of 3-3.5ml/kg/min (VO2max) and 17.2 H2O (MIP). The power calculation resulted in a total of 63 persons. Therefore, the investigators plan to recruit 64 patients.
Participants will be randomly assigned to a HIT program or a MIT program. Primary outcomes are diaphragm muscle strength, -endurance, -fatigue and - activation. Secondary outcomes are cardiorespiratory fitness, postural control, pain, disability, depressive mood and anxiety. Primary and secondary outcomes will be assessed at 5 timepoints (0 weeks, 6 weeks, 12 weeks, 3 months after intervention, 12 months after intervention).
To analyze the data, JMP Pro (15.2 SAS Institute Inc, Cary, USA) will be used. Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the effectiveness of the HIT vs MIT intervention), a linear mixed model will be fitted with 'time' and 'group' as covariates, and incorporated random intercepts for the participants to account for the within-subject variation. To evaluate associations between diaphragm functioning and predictors/mediators for therapy success, correlations and multivariate regression analysis will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •n (CNSLBP patients):
- •Dutch-speaking
- •Adults (age 18-65 years)
- •Chronic low back pain (i.e. pain localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain for a period of at least twelve weeks), with a non-specific origin (i.e. pain of a nociceptive mechanical nature, not attributable to a recognizable, known, specific pathology, e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)
排除标准
- •(CNSLBP patients):
- •History of spinal fusion
- •A musculoskeletal disorder aside from chronic nonspecific low back pain that could affect the correct execution of the therapy program
- •Baseline characteristics that could affect the evaluation of the outcomes (a pacemaker, a chronic obstructive respiratory disorder, or known balance/vestibular problems)
- •Severe comorbidities (e.g., paresis or sensory disturbances of neurological origin, diabetes mellitus, rheumatoid arthritis)
- •Ongoing compensation claims
- •Negative advice from the general practitioner regarding sports medical screening
- •Pregnancy
- •Persons that are not able to attend regular appointments
- •Inclusion Criteria (healthy volunteers):
- •Dutch-speaking
- •Adults (age 18-65 years)
- •No acute or chronic complaints
- •Exclusion Criteria (healthy volunteers):
- •History of spinal fusion
- •Baseline characteristics that could affect the evaluation of the outcomes (a pacemaker, a chronic obstructive respiratory disorder, or known balance/vestibular problems)
- •Severe comorbidities (e.g., paresis or sensory disturbances of neurological origin, diabetes mellitus, rheumatoid arthritis)
- •Ongoing compensation claims
- •Negative advice from the general practitioner regarding sports medical screening
- •Pregnancy
结局指标
主要结局
Diaphragm activation (timing)
时间窗: FU2 (12 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm endurance
时间窗: POST (12 weeks)
Participants will undergo an inspiratory resistive loading protocol at a fixed intensity of 80% of MIP (POWERbreathe International Ltd., type KH2, Warwickshire, UK). The participants will be instructed to inhale maximally and as rapidly as possible at a frequency of 15 breaths/minute and a 0.5 duty cycle. The time to task failure will be recorded as the inspiratory muscle endurance time.
Diaphragm fatigue
时间窗: FU2 (12 months follow-up)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm strength
时间窗: FU2 (12 months follow-up)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Diaphragm activation (amplitude)
时间窗: FU2 (12 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
次要结局
- Brief Pain Inventory (BPI)(FU2 (12 months follow-up))
- Beck Depression Inventory (BDI)(FU2 (12 months follow-up))
- Relative proprioceptive weighting ratio(FU2 (12 months follow-up))
- Modified Oswestry Disability Index (MODI)(FU2 (12 months follow-up))
- State-Trait Anxiety Inventory (STAI)(FU2 (12 months follow-up))
- Thermal Detection and Pain Threshold Temperatures(FU2 (12 months follow-up))
- Temporal Summation of Pain (TSP)(FU2 (12 months follow-up))
- Conditioned Pain Modulation (CPM)(FU2 (12 months follow-up))
研究者
Annick Timmermans
Prof. Dr.
Hasselt University