Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial

NCT06491121 | Recruiting

• 1 other identifier: T000822N
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

Chronic low back pain (CLBP) is one of the most common chronic musculoskeletal disorder worldwide and is responsible for the highest levels of disability of all diseases. All state-of-the-art guidelines recommend implementing exercise therapy (ET) in CLBP management. Researchers have shown that a novel ET modality, namely high intensity training (HIT), can be valuable. A clinical evaluation study in a larger spectrum of persons with CLBP in a rehabilitation centre setting is essential. Thereby, technology might support HIT. The primary goal of this clinical trial is to evaluate the short- and long-term effectiveness of a time contingent individualized High intensity training (HIT) protocol on disability compared to moderate intensity training (MIT) in persons with severely disabling chronic low back pain (CLBP). Secondary goals entail 1) evaluating short- and long-term effectiveness of HIT on psychosocial correlates, central pain processing, and broad physical fitness, 2) investigating additional effects of (prolonged) HIT at home, 3) investigating added value of technology through a mobile (smartphone) and dashboard (computer) application that offers support during home training, 4) evaluating cost-effectiveness of (technology supported) HIT compared to MIT. The main research question\[s\] (RQ) it aims to answer are:

• RQ1: To what extent is HIT effective on the short- and long term to improve disability in persons with severely disabling CLBP compared to MIT as used in usual care?
• RQ2a: To what extent does HIT have a short- and/or long-term effect on central pain processing and psychosocial correlates in persons with severely disabling CLBP?
• RQ2b:To what extent does HIT have a short- and/or long-term effect on outcomes related to broad physical fitness in persons with severely disabling CLBP?
• RQ3a: To what extent does prolonged (technology-supported) HIT at home provide additional training effects in persons with severely disabling CLBP?
• RQ3b:To what extent does a mobile application that offers support for HIT at home provide added value for treatment outcomes of persons with severely disabling CLBP?
• RQ3c:To what extent is the techno-HIT application usable and qualitative (assessed by SUS and uMARS) as a therapeutic support mechanism, as evaluated by persons with severely disabling CLBP?
• RQ4: To what extent is HIT or HIT supported by a mobile application cost effective compared to MIT for patients with severely disabling CLBP?

Conditions

Chronic Low-back Pain; Exercise Therapy; Telerehabilitation

Outcome Measures

Primary Outcomes (6)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T-1: PRE (pre biopsychosocial education program, 2 weeks before the start of intervention)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T0: PRE (post biopsychosocial education program, at the start of intervention)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T1: MID (After completing the 12-week protocol in hospital)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T2: POST (After completing the 12-week protocol at home)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T3: POST (6 months follow-up)

• Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min

  This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.

  T4: POST (18 months follow-up)

Secondary Outcomes (135)

• Brief Pain Inventory (BPI) - Time necessary for completion: 5 min

  T-1: PRE (pre biopsychosocial education program, 2 weeks before the start of intervention)

• Brief Pain Inventory (BPI) - Time necessary for completion: 5 min

  T0: PRE (post biopsychosocial education program, at the start of intervention)

• Brief Pain Inventory (BPI) - Time necessary for completion: 5 min

  T1: MID (After completing the 12-week protocol in hospital)

• Brief Pain Inventory (BPI) - Time necessary for completion: 5 min

  T2: POST (After completing the 12-week protocol at home)

• Brief Pain Inventory (BPI) - Time necessary for completion: 5 min

  T3: POST (6 months follow-up)

Study Arms (3)

TECHNO-HIT group

EXPERIMENTAL

Technology supported High Intensity Training

Other: Technology supported High Intensity Training

HIT group

EXPERIMENTAL

High Intensity Training

Other: High Intensity Training

MIT group

ACTIVE COMPARATOR

Moderate Intensity Training

Other: Moderate Intensity Training

Interventions

Technology supported High Intensity Training OTHER

patients will perform a 12-week HIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory interval, general resistance, and core muscle strength training, all at high intensity. phase 2 is a similar 12-week HIT program at home, supported by a smartphone application

TECHNO-HIT group

Moderate Intensity Training OTHER

patients will perform a 12-week MIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory continuous load, general resistance and core muscle training, all at moderate intensity. Phase 2 is a similar 12-week MIT program at home with an exercise program on paper.

MIT group

High Intensity Training OTHER

patients will perform a 12-week HIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory interval, general resistance, and core muscle strength training, all at high intensity. phase 2 is a similar 12-week HIT program at home with an exercise program on paper.

HIT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• speak Dutch
• be 18 to 65 years old
• have nonspecific CLBP defined as chronic primary musculoskeletal pain (ICD-11: MG30.011) in the low back persisting for at least 12 weeks12, whereby fluctuations in pain can be present and pain can be alternated by remission phases. Furthermore, regarding the specification of 'severity', only participants with a profile consisting of a score of \>20% on the Modified Oswestry disability Index (i.e. 'moderate disability') will be included.
• have and make use of a working iOS/Android smartphone

You may not qualify if:

• when they have had spinal fusion surgery
• when they have a musculoskeletal and/or chronic disorder aside from CLBP that could affect the correct execution of the therapy program or evaluation of the outcomes
• when they have severe comorbidities (e.g., paresis or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis)
• when they are pregnant
• when they have ongoing compensation claims
• when they are not able to attend regular therapy appointments

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (4)

Universitair Ziekenhuis Antwerpen (UZA)

Wilrijk, Antwerpen, 2610, Belgium

NOT YET RECRUITING

University of Antwerp

Wilrijk, Antwerpen, 2610, Belgium

NOT YET RECRUITING

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Related Publications (1)

• van Eetvelde JS, Timmermans AAA, Coninx K, Kempeneers K, Meeus M, Marneffe W, Meus T, Meuwissen I, Roussel NA, Stassijns G, Verbrugghe J. Technology supported High Intensity Training in chronic non-specific low back pain (the Techno-HIT trial): study protocol of a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 7;10(4):e002180. doi: 10.1136/bmjsem-2024-002180. eCollection 2024.

  PMID: 39381416 DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

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

Study Officials

• Annick Timmermans

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Van Eetvelde

CONTACT

+3211292125; julie.vaneetvelde@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: A double blind (outcome assessor \& statistical analysis) three-armed multicentre RCT will be conducted. This RCT will adhere to Good Clinical Practice (GCP) regulations.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: July 8, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)