LOMB'ACTIV: Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05404854

Collaborator

(none)

156

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Other: Physical Activity Other: sedentarity Other: Measurement of explicit motivation Other: Measurement of implicit attitudes

Study Design

Study Type:

Observational

Anticipated Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Changes in Physical Activity, Sedentary Behavior and Associated Motivations Following a Rehabilitation Program for Chronic Low Back Pain Patients

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
chronic low back pain patients Physical Activity by wearing an accelerometer for 7 days before and after the rehabilitation program sedentarity by wearing an accelerometer for 7 days before and after the rehabilitation program Measurement of explicit motivation Measurement of implicit attitudes	Other: Physical Activity wearing an accelerometer for 7 days before and after the rehabilitation program Other: sedentarity wearing an accelerometer for 7 days before and after the rehabilitation program Other: Measurement of explicit motivation Explicit motivation will be assessed using self-report questionnaires. Explicit attitudes using a 7-point bipolar response scale, participants will be asked to indicate for each of the 4 pairs of positive and negative adjectives used how much they associate them with regular PA and sedentary behaviors, respectively. Perceived behavioral control using a 7-point bipolar response scale, patients will be asked to indicate how well they felt they were able to engage in regular PA, and limit their sedentary behaviors, respectively, based on two items. Intentions using a 7-point bipolar response scale, patients will be asked to indicate how much they intend to adopt regular physical activity, and limit their sedentary behaviors, respectively, according to two items. Fears and beliefs related to physical activity and work will be measured by the FABQ in its French version Other: Measurement of implicit attitudes Implicit attitudes will be assessed by administering an Implicit Association Test on physical and sedentary activities. Sitting in front of a computer, participants will see a series of words appear in the middle of the screen referring to 4 conceptual categories - located at the top of the screen. Two represent the targeted behaviours (here, physical activity versus sedentary lifestyle) while the remaining two represent attributes (here, positive versus negative adjectives). The adjectives used will be the same as those used to measure explicit attitudes. The instructions given to the participant are to classify the words as quickly as possible, according to the semantic category to which they belong

Arm

Intervention/Treatment

chronic low back pain patients

Physical Activity by wearing an accelerometer for 7 days before and after the rehabilitation program sedentarity by wearing an accelerometer for 7 days before and after the rehabilitation program Measurement of explicit motivation Measurement of implicit attitudes

Other: Physical Activity

wearing an accelerometer for 7 days before and after the rehabilitation program

Other: sedentarity

wearing an accelerometer for 7 days before and after the rehabilitation program

Other: Measurement of explicit motivation

Explicit motivation will be assessed using self-report questionnaires. Explicit attitudes using a 7-point bipolar response scale, participants will be asked to indicate for each of the 4 pairs of positive and negative adjectives used how much they associate them with regular PA and sedentary behaviors, respectively. Perceived behavioral control using a 7-point bipolar response scale, patients will be asked to indicate how well they felt they were able to engage in regular PA, and limit their sedentary behaviors, respectively, based on two items. Intentions using a 7-point bipolar response scale, patients will be asked to indicate how much they intend to adopt regular physical activity, and limit their sedentary behaviors, respectively, according to two items. Fears and beliefs related to physical activity and work will be measured by the FABQ in its French version

Other: Measurement of implicit attitudes

Implicit attitudes will be assessed by administering an Implicit Association Test on physical and sedentary activities. Sitting in front of a computer, participants will see a series of words appear in the middle of the screen referring to 4 conceptual categories - located at the top of the screen. Two represent the targeted behaviours (here, physical activity versus sedentary lifestyle) while the remaining two represent attributes (here, positive versus negative adjectives). The adjectives used will be the same as those used to measure explicit attitudes. The instructions given to the participant are to classify the words as quickly as possible, according to the semantic category to which they belong

Outcome Measures

Primary Outcome Measures

Physical Activity (PA) [between baseline to 3 months]
Change in the proportion of participants meeting the recommended PA level from pre-program (T0) to 3 months after returning home (T3) (Canning & Hicks, 2020; Ormel et al., 2021).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.