NCT05234008: HIT-HOME

Technology Supported High Intensity Training at Home for Persons With Chronic Low Back Pain

Status unknown Phase 3 Last updated 17 February 2022

What this trial tests

Phase 3 trial testing High intensity training at home in Chronic Low-back Pain in 15 participants. Status unknown.

Timeline

15 February 2022

Primary endpoint
1 September 2022

1 January 2023

Quick facts

Lead sponsor	Hasselt University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	15 February 2022
Primary completion	1 September 2022
Estimated completion	1 January 2023
Sites	1 location across Belgium

Drugs / interventions tested

• High intensity training at home

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →
• Exercise Therapy — all drugs for Exercise Therapy →
• Telerehabilitation — all drugs for Telerehabilitation →

Sponsor

Hasselt University

Who can join

Adults 25 to 60, any sex, with Chronic Low-back Pain or Exercise Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1\. Background 1.1 Introduction Chronic low back pain (CLBP) is the most disabling musculoskeletal disorder worldwide4. Exercise therapy can improve CLBP, but effect sizes remain modest. Recently, our research group has shown that high intensity training (HIT) is a feasible and effective therapy modality to significantly improve physical fitness and reduce functional disability in comparison to moderate intensity training in persons with moderately disabling CLBP9. However, persons with CLBP often do not continue exercising after discharge, which can lead to a decline of (long term) treatment effects. A technology supported home program, that guides the substantial effort that is necessary for further improvement, may enhance (the retention of) training effects.

1.2 Objective, research questions, and hypotheses

Primary objective:

To evaluate the feasibility of a technology supported HIT program performed at home in persons with CLBP.

Secondary objective:

To assess the clinical effectiveness of a technology supported HIT program performed at home in persons with CLBP.

Research questions and hypotheses:

Research question (RQ)1 - To which extent is it feasible to perform HIT at home in persons with CLBP? Hypothesis (HP)1 - A high intensity training program performed at home by persons with CLBP is feasible, conceptualized by retained or improved participant motivation, high therapy adherence, and absence of adverse events.

RQ2 - To which extent is it feasible to use Physitrack as a supportive technology application during HIT at home in persons with CLBP? HP2 - It is feasible to use Physitrack to support persons with CLBP that perform a HIT program at home (i.e. provide information concerning the exercise program and provide feedback), conceptualized by an evaluation of the Physitrack application on the usability score of 'above average'.

RQ3 - To which extent is a technology supported HIT program an effective therapy modality to treat persons with CLBP? HP3: A technology supported HIT program is an effective therapy modality to treat persons with CLBP, conceptualized by a significant increase in physical fitness, and decrease in pain intensity and functional disability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. High-Intensity Training Telerehabilitation for Persons with Chronic Low Back Pain: A Pilot Clinical Trial.
   Meus T, Timmermans A, Klaps S, Verbrugghe J. · · 2024 · cited 1× · PMID 39768521 · DOI 10.3390/jcm13247599