High intensity training to improve diaphragm function in people with chronic low back pain
The Breathe-(H)IT Trial: Multimodal High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain
This study is testing whether high intensity training can improve diaphragm strength and overall health in people with chronic low back pain compared to moderate intensity training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Diepenbeek, Limburg) |
| Trial ID | NCT05384457 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effects of high intensity training (HIT) versus moderate intensity training (MIT) on diaphragm muscle strength, endurance, fatigue, and activation in individuals with chronic nonspecific low back pain (CNSLBP). The study also examines how changes in diaphragm functioning relate to improvements in cardiorespiratory fitness, postural control, pain, and disability. Additionally, it explores the role of depressive mood and anxiety in moderating the effects of HIT on diaphragm function. The hypothesis is that HIT will yield greater improvements compared to MIT in this patient population.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking adults aged 18-65 with chronic nonspecific low back pain lasting at least 12 weeks.
Not a fit: Patients with a history of spinal fusion or other significant musculoskeletal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance diaphragm function and reduce disability in patients suffering from chronic low back pain.
How similar studies have performed: Previous studies have indicated that high intensity training can lead to better outcomes in similar populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criterian (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) Exclusion Criteria (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
Where this trial is running
Diepenbeek, Limburg
- Hasselt University — Diepenbeek, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Annick Timmermans — REVAL-Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium
- Study coordinator: Sim Klaps
- Email: sim.klaps@uhasselt.be
- Phone: +32(0)11268467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.