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

NCT05234008 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Low-back Pain
  • Exercise Therapy
  • Telerehabilitation

Interventions

OTHER

High intensity training at home

A HIT exercise intervention is performed. Four sessions are performed at REVAL Research Center to educate participants on the exercise protocol. Eight exercise sessions are performed at home with support of Physitrack (a mobile application for participants and a software platform for researchers). In-center program (2 weeks, 4 sessions): Participants perform a concurrent exercise protocol of 1h-1.5h, as published by our research team previously, consisting of cardiorespiratory, general resistance, and core muscle training, all at high intensity. Home sessions (4 weeks, 8 sessions): Researchers provide participants with a fitness bike, smartwatch, and training mat. Using Physitrack, researchers formulate a personalized HIT program to be performed at home for each participant by selecting from \>3500 exercises or insert a new exercise to add to the library. This HIT program resembles the program performed in the rehabilitation center as much as possible.

Sponsors & Collaborators

  • Hasselt University

    lead OTHER

Principal Investigators

  • Annick Timmermans, PhD · Hasselt University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-09-01
Completion
2023-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234008 on ClinicalTrials.gov