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

Chronic Low-back Pain Clinical Trial

— LOMB'ACTIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404854
• Other study ID #: Local/2022/MH-01
• Secondary ID: 2022-A00549-34
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Matthieu HAAS
• Phone: + 33 623 871 992
• Email: matthieu.haas[@]umontpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Physical Activity
wearing an accelerometer for 7 days before and after the rehabilitation program
• sedentarity
wearing an accelerometer for 7 days before and after the rehabilitation program
• 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
• 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

Locations

Country	Name	City	State
France	CHU de Clermont Ferrand	Clermont Ferrand
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity (PA)	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).	between baseline to 3 months