Clinical trial NCT05404854: Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients
Official title: Changes in Physical Activity, Sedentary Behavior and Associated Motivations Following a Rehabilitation Program for Chronic Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Keywords: rehabilitation
sedentary
motivation
physical activity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited before their stay in the Physical Medicine and Rehabilitation departments of the University Hospital Centres of Clermont-Ferrand, Montpellier and Nîmes, on a voluntary basis, after medical advice and after verification of all the criteria mentioned below.

Brief summary: IIn 2016, chronic low back pain (CLBP) was the leading cause of years lived with disability worldwide. This condition impacts social interactions, work life, and can lead to an altered quality of life for patients.

For these patients, physical activity (PA) can reduce pain, improve function and the rate of return to work. According to the French National Authority for Health, it is the main treatment in the management of these patients. Nevertheless, the literature reports PA levels that are relatively comparable to those of the general population. Considering that a large proportion of adults struggle to meet these thresholds, we can infer that the same is true for CLBP patients. In addition to PA, the World Health Organization recommends that all adults should limit the amount of time spent in sedentary behaviors. Thus, CLBP patients should adopt an active lifestyle, characterized by regular PA and limited sedentary behaviors (SB).

In view of these elements, it is essential to implement dedicated interventions. The literature reports mixed results with work focused on PA promotion. No study has focused on i) the reduction of CS, ii) the rehabilitation programs (RP) proposed in France.

On the other hand, there is a need to better understand what determines engagement in such behaviors. Among these determinants are several psychological variables related to behavioral intentions. A recent line of research indicates that beyond these motivational dimensions, which are explicit in nature, certain implicit processes are significantly associated with the adoption or non-adoption of certain health-related behaviors. This result has been observed in the context of chronic disease (respiratory patients, metabolic patients) but remains unexplored in patients with chronic low back pain.

The aim of this study is to simultaneously question these different aspects: the effects of a RP on changes in PA and CS, in relation to motivational changes in a population of CLBP patients.


Eligibility criteria: Inclusion Criteria:

* Admitted to a rehabilitation program,
* Presenting chronic low back pain (i.e., \> 3 months),
* Age \> 18 years,
* Literacy.

Exclusion Criteria:

* Inability or refusal to answer a questionnaire,
* Protected adults,
* Participation in another study
* Withdrawal of consent,
* If deemed necessary by the principal investigator for the welfare and/or safety of the participant,
* In the event of an occurrence of a non-inclusion criterion.

Primary outcomes:
measure: Physical Activity (PA)
timeFrame: between baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: