Chronic Low-back PainLOMB'ACTIVNCT05404854
Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients
An observational study of Chronic Low-back Pain, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Physical Activity, sedentarity and Measurement of explicit motivation
- How many people
- 89 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Aug 2022to 20 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Admitted to a rehabilitation program,
- Presenting chronic low back pain (i.e., > 3 months),
- Age > 18 years,
- Literacy.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Clermont Ferrand
Clermont-Ferrand, 63000
CHU de Montpellier
Montpellier, 34090
CHU de Nîmes
Nîmes
About this study
Official title: Changes in Physical Activity, Sedentary Behavior and Associated Motivations Following a Rehabilitation Program for Chronic Low Back Pain Patients
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).
Read more
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Physical Activity, sedentarity, Measurement of explicit motivation, Measurement of implicit attitudes
- Keywords
- rehabilitation, sedentary, motivation, physical activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
wearing an accelerometer for 7 days before and after the rehabilitation program
sedentarityOther
wearing an accelerometer for 7 days before and after the rehabilitation program
Measurement of explicit motivationOther
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 attitudesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physical Activity; Other: sedentarity; Other: Measurement of explicit motivation; Other: Measurement of implicit attitudes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: between baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start22 Aug 2022
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404854
- Sponsor's protocol ID
- Local/2022/MH-01
- Other IDs
- 2022-A00549-34
- Acronym
- LOMB'ACTIV
- Status last verified
- Dec 2025
- First submitted
- 31 May 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40327431
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physical Activity, Sedentary Behavior and Associated Motivations Following a Rehabilitation Program for Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05404854
- Acronym / sponsor ID
- LOMB'ACTIV / Local/2022/MH-01
- Conditions
- Chronic Low-back Pain
- Keywords
- rehabilitation, sedentary, motivation, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic low back pain patients | – | Other: Physical Activity, Other: sedentarity, Other: Measurement of explicit motivation, Other: Measurement of implicit attitudesPhysical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Admitted to a rehabilitation program,
- Presenting chronic low back pain (i.e., > 3 months),
- Age > 18 years,
- Literacy.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activitywearing an accelerometer for 7 days before and after the rehabilitation program | Other | chronic low back pain patients |
| sedentaritywearing an accelerometer for 7 days before and after the rehabilitation program | Other | chronic low back pain patients |
| Measurement of explicit motivationExplicit 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 | chronic low back pain patients |
| Measurement of implicit attitudesImplicit 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 | Other | chronic low back pain patients |
Primary outcome
Physical Activity (PA)
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 40327431Haas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (PA) (time frame: between baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.