The Breathe-(H)IT Trial: Multimodal High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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)

• Dutch-speaking

• Adults (age 18-65 years)

• No acute or chronic complaints

Locations
Other Locations
Belgium
Hasselt University
RECRUITING
Diepenbeek
Contact Information
Primary
Sim Klaps
sim.klaps@uhasselt.be
+32(0)11268467
Backup
Marleen Missotten
CME@uhasselt.be
+32(0)11 26 85 02
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 64
Treatments
Experimental: High intensity training (HIT)
Each participant will follow 24 therapy sessions (2 x 1.5 hours/week). The experimental group will perform a multimodal HIT protocol. Cardiorespiratory training will consist of a high-intensity interval training protocol on a cycle ergometer. After a five-minute warm-up, interval training will start, consisting of five one-minute bouts (110 RPM at 100% VO2max workload), separated by one minute of active rest (75 RPM at 50% VO2max workload). Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 80% of the one repetition maximum. Core muscle training will consist of a circuit of six static core exercises (glute bridge, glute clam, superman back extension, adapted plank, adapted side plank, shoulder retraction with hip hinge) at 60% of the maximal voluntary contraction.
Active_comparator: Moderate intensity training (MIT)
Each participant will follow 24 therapy sessions (2 x 1.5 hours/week). The control group will perform a multimodal MIT protocol. Cardiorespiratory training will consist of a moderate-intensity continuous training protocol on a cycle ergometer. After a five-minute warm up, participants start continuous training comprising of 14 minutes of moderate-intensity cycling (90RPM at 60%VO2max workload). The duration will increase weekly with 1'40'' up to 22'40''. Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 60% of the one repetition maximum. Core muscle training will be identical to the protocol described in 'Core muscle training HIT' with the exception of the exercise intensity. Only exercises with low relative core muscle activation will be used.
Related Therapeutic Areas
Sponsors
Leads: Hasselt University
Collaborators: Maastricht University, KU Leuven

This content was sourced from clinicaltrials.gov