High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain

NCT05384457 | Unknown

• 1 other identifier: B1152021000029
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain; Chronic Low-back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (22)

• Diaphragm strength

  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, and compared with reference values.

  PRE (baseline)

• Diaphragm strength

  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.

  MID (6 weeks)

• Diaphragm strength

  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.

  POST (12 weeks)

• Diaphragm strength

  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.

  FU1 (3 months follow-up)

• Diaphragm strength

  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.

  FU2 (12 months follow-up)

• Diaphragm endurance

  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.

  PRE (baseline)

• Diaphragm endurance

  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.

  POST (12 weeks)

• Diaphragm fatigue

  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.

  PRE (baseline)

• Diaphragm fatigue

  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.

  MID (6 weeks)

• Diaphragm fatigue

  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.

  POST (12 weeks)

• Diaphragm fatigue

  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.

  FU1 (3 months follow-up)

• Diaphragm fatigue

  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.

  FU2 (12 months follow-up)

• Diaphragm activation (amplitude)

  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.

  PRE (baseline)

• Diaphragm activation (amplitude)

  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.

  MID (6 weeks)

• Diaphragm activation (amplitude)

  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.

  POST (12 weeks)

• Diaphragm activation (amplitude)

  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.

  FU1 (3 months follow-up)

• Diaphragm activation (amplitude)

  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.

  FU2 (12 months follow-up)

• Diaphragm activation (timing)

  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.

  PRE (baseline)

• Diaphragm activation (timing)

  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.

  MID (6 weeks)

• Diaphragm activation (timing)

  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.

  POST (12 weeks)

• Diaphragm activation (timing)

  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.

  FU1 (3 months follow-up)

• Diaphragm activation (timing)

  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.

  FU2 (12 months follow-up)

Secondary Outcomes (36)

• Modified Oswestry Disability Index (MODI)

  PRE (baseline)

• Modified Oswestry Disability Index (MODI)

  MID (6 weeks)

• Modified Oswestry Disability Index (MODI)

  POST (12 weeks)

• Modified Oswestry Disability Index (MODI)

  FU1 (3 months follow-up)

• Modified Oswestry Disability Index (MODI)

  FU2 (12 months follow-up)

Study Arms (2)

High intensity training (HIT)

EXPERIMENTAL

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.

Other: High intensity training

Moderate intensity training (MIT)

ACTIVE COMPARATOR

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.

Other: Moderate intensity training

Interventions

High intensity training OTHER

Participants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training.

High intensity training (HIT)

Moderate intensity training OTHER

Participants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training.

Moderate intensity training (MIT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Dutch-speaking
• Adults (age 18-65 years)
• No acute or chronic complaints
• 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

Sponsors & Collaborators

• Hasselt University: lead
• KU Leuven: collaborator
• Maastricht University: collaborator

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Annick Timmermans

  REVAL-Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sim Klaps

CONTACT

+32(0)11268467; sim.klaps@uhasselt.be

Marleen Missotten

CONTACT

+32(0)11 26 85 02; CME@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 20, 2022
• Study Start: August 22, 2022
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)