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

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

Interventions

OTHER

Technology supported High Intensity Training

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

OTHER

Moderate Intensity Training

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.

OTHER

High Intensity Training

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.

Sponsors & Collaborators

• Hasselt University

  lead OTHER

Principal Investigators

• Annick Timmermans · Hasselt University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-27

Primary Completion

2027-08-31

Completion

2029-03-31

Countries

• Belgium

Study Locations