- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404854
Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients (LOMB'ACTIV)
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).
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63000
- Chu de Clermont Ferrand
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Montpellier, France, 34090
- CHU de Montpellier
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Nîmes, France
- CHU de Nîmes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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wearing an accelerometer for 7 days before and after the rehabilitation program
wearing an accelerometer for 7 days before and after the rehabilitation program
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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical Activity (PA)
Time Frame: between baseline to 3 months
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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).
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between baseline to 3 months
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Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nimes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local/2022/MH-01
- 2022-A00549-34 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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