Schedule of enrolment, interventions and assessments in accordance with the SPIRIT 2013 guidelines

Schedule of enrolment, interventions and assessments in accordance with the SPIRIT 2013 guidelines

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Chronic low back pain (CLBP) is one of the most common chronic musculoskeletal disorders worldwide. Guidelines recommend exercise therapy (ET) in CLBP management, but more research is needed to investigate specific ET modalities and their underlying mechanisms. The primary goal of this study is to evaluate the short-term and long-term effectiveness...

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... Third, the relatively limited sample size represents an additional weakness, as it reduces the statistical power and validity of the results. However, despite these limitations, this pilot clinical trial serves as a valuable stepping stone toward a larger randomized clinical controlled trial, which aims to provide more robust evidence regarding the effectiveness of the intervention [53]. ...
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Background/Objectives: High-intensity training (HIT) has been shown to enhance physical fitness and reduce functional impairments in persons with moderately disabling chronic nonspecific low back pain (CNSLBP). However, sustaining these improvements post-rehabilitation remains a challenge. To address this, a home-based, technology-supported HIT program utilizing telerehabilitation can be implemented at home. This study assesses the feasibility and clinical effectiveness of a telerehabilitation HIT program for persons with CNSLBP. Methods: The pilot clinical trial (NCT05234008) recruited 15 persons with CNSLBP. Participants completed a 6-week multimodal HIT intervention with 12 bi-weekly sessions. The first four sessions were organized at REVAL Research Center, followed by eight home-based sessions using the Physitrack® platform. Assessments were conducted at baseline (PRE), two weeks into the intervention (MID), and immediately post-intervention (POST). Outcome measures included maximal oxygen uptake (VO2max) testing, disease-related outcomes, feasibility, motivation assessed via questionnaires, and system usability and adherence tracked through Physitrack® technology. Results: Fourteen participants (seven females; age: 45.9 years) successfully completed the program without adverse events. Based on PRE–POST comparisons, motivation levels remained high (Motivation Visual Analog Scale: −1.2 ± 0.9, p = 0.043) despite reduced motivation at POST. Improvements were also observed in pain (Numeric Pain Rating Scale: −1.8 ± 0.2, p = 0.026), disability (Modified Oswestry Disability Index: −12.1 ± 10.2, p = 0.002), fear-avoidance (Fear-Avoidance Components Scale: −10.1 ± 5.8, p = 0.005), and exercise capacity (VO2max: 4.4 ± 1.6, p = 0.048). Conclusions: The HITHOME study is the first to investigate the feasibility and effectiveness of a telerehabilitation HIT program for persons with CNSLBP. The results underscore the feasibility of implementing a home-based HIT program to support adherence to vigorous exercise programs and improve clinical outcomes in this population. Additionally, the findings emphasize technology’s potential importance in enhancing home-based exercise therapy and lay the groundwork for future studies on blended care and telerehabilitation using HIT in CNSLBP.