NCT05404854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

May 31, 2022

Last Update Submit

December 3, 2025

Conditions

Keywords

rehabilitationsedentarymotivationphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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 ActivityOther: sedentarityOther: Measurement of explicit motivationOther: Measurement of implicit attitudes

Interventions

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

chronic low back pain patients

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

chronic low back pain patients

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

chronic low back pain patients

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

chronic low back pain patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

CHU de Nîmes

Nîmes, France

Location

Related Publications (1)

  • Haas M, Boiche J, Tavares-Figuereido I, Courbis AL, Dupeyron A. Changes in physical activity, sedentary behaviors, and associated motivation after multidisciplinary rehabilitation program for chronic low back pain patients. Int J Rehabil Res. 2025 Jun 1;48(2):106-112. doi: 10.1097/MRR.0000000000000667. Epub 2025 Apr 9.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

August 22, 2022

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations