Preparatory Lifestyle Program Before Functional Restoration for Chronic Low Back Pain (PFRP-FRP)

A Preparatory Lifestyle-Based Physical Activity Intervention Before Intensive Rehabilitation for Chronic Low Back Pain: A Controlled Clinical Study

Chronic low back pain is a major public health issue worldwide, affecting hundreds of millions of people. Intensive multidisciplinary rehabilitation programs, such as the Functional Restoration Program (FRP), are effective in improving physical capacity, quality of life, and return to work in these patients. However, many patients reach these programs in a deconditioned state and may struggle to engage fully with the intensive demands. Additionally, during the waiting period before entering such programs, patients often receive no structured support, which may worsen sedentary behavior and physical deconditioning.

This study examined whether adding a 12-week preparatory phase before the FRP could help patients enter the intensive program in better condition and prevent deterioration during the waiting period. The preparatory phase, called PFRP, was designed as a lifestyle-based intervention emphasizing patient autonomy: participants attended one 2-hour supervised session per week at the Day Hospital and were encouraged to practice exercises at home between sessions. The program also included therapeutic education about pain and self-management strategies.

Twenty-four adults with chronic low back pain were included in two groups. The PFRP group (14 participants) received the 12-week preparatory phase followed by the 4-week FRP. The control group (10 participants) received the FRP alone after an equivalent waiting period. Assessments were conducted at four time points: at the start of the preparatory phase or waiting period (T0), at FRP entry (T1), at FRP exit (T2), and four months after FRP completion (T3).

The two co-primary outcomes were sedentary behavior (measured by the ONAPS questionnaire) and the impact of pain on daily activities (measured by the DALLAS questionnaire). Secondary outcomes included physical fitness, fear-avoidance beliefs, pain intensity, and psychological well-being. The study aimed to evaluate (1) whether the preparatory phase prevents behavioral and functional deterioration during the waiting period, and (2) whether it supports better medium-term maintenance of improvements after the intensive program.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Pain
• Intervention / Treatment: Behavioral: 12-week preparatory lifestyle-based physical activity program; Behavioral: 4-week intensive Functional Restoration Program

Detailed Description

Background and rationale

Chronic low back pain is a leading cause of disability worldwide. Intensive multidisciplinary Functional Restoration Programs (FRP), introduced in France in the 1990s, deliver comprehensive physical, psychological, and cognitive-behavioral care over a short period and have demonstrated effectiveness on physical capacity, quality of life, and return to work. As these programs have opened to broader patient populations, marked disparities in therapeutic response have emerged. Several factors may explain heterogeneity in outcomes: differences in baseline deconditioning, severe kinesiophobia, professional and family constraints limiting adherence after discharge, and the difficulty of transferring acquired skills to daily life. The waiting period before program entry is often unstructured, with no specific intervention provided, potentially allowing sedentary behavior and physical deconditioning to progress.

A preparatory phase grounded in adapted physical activity, hereafter referred to as PFRP, was developed to address these gaps. The PFRP follows a lifestyle-based approach centered on patient autonomy and self-directed practice, aiming to (1) prepare deconditioned patients physically and psychologically for the intensive program, and (2) develop self-management skills earlier in the care pathway to facilitate transfer of acquired behaviors after program completion. To our knowledge, no previous study has examined a preparatory phase prior to a conservative functional restoration program; prehabilitation research has focused primarily on pre-surgical contexts.

Study design

This was a prospective, controlled, non-randomized, single-center study conducted in a rehabilitation center in northern France. Participants were assigned to one of two groups according to admission scheduling and organizational constraints of the residential program (groups of 2 to 6 patients). Randomization was not feasible due to the longitudinal nature of the study and admission logistics. Identical inclusion and exclusion criteria were applied to both groups to limit selection bias.

Interventions

PFRP group: 12-week preparatory phase delivered in group format at the Day Hospital, totaling 26 hours of therapeutic exposure (2-hour initial assessment, weekly 2-hour supervised sessions until FRP entry, 4 hours dedicated to exercise learning, 2 hours of therapeutic education). Approximately 18 hours of autonomous practice at home were prescribed (69% of total exposure). Supervised sessions, led by an Adapted Physical Activity Instructor, included resistance training at 60% of 3-repetition maximum, mobilization and stretching, and cardiorespiratory training on an ergocycle. Sessions were scheduled at the end of the day to accommodate working participants. Therapeutic education addressed misconceptions about pain and self-management strategies. After the 12-week phase, PFRP participants entered the 4-week intensive FRP.

FRP group: 4-week intensive program in a group setting at the Day Hospital, totaling 117 hours (34 hours of independent training, 76.5 hours of supervised group sessions including physiotherapy, occupational therapy, adapted physical activities, balneotherapy, and stretching). Four weekly therapeutic education sessions addressed pain perception, post-program physical activity planning, and exercise physiology. The FRP group received no structured intervention during the waiting period equivalent to the PFRP phase.

Assessments

Outcomes were assessed at four time points: T0 (start of preparatory phase or waiting period), T1 (FRP entry), T2 (FRP exit), and T3 (4-month follow-up).

Co-primary outcomes were selected a priori based on the theoretical framework of the intervention: (1) sedentary behavior measured by the ONAPS-SED subscale, as a direct measure of the behavioral change targeted by the intervention, and (2) impact of pain on Daily Activities measured by the DALLAS-DA subscale, reflecting functional autonomy in everyday life. The ONAPS questionnaire was not administered at T2 because intensive hospitalization does not reflect habitual physical activity behavior.

Secondary outcomes were organized by hypothesized mechanism: other DALLAS subscales (Work/Leisure Activities, Anxiety/Depression, Social interest), other ONAPS subscales (total physical activity, Moderate-to-Vigorous Physical Activity Intensity), functional disability (EIFEL), cognitive mediators (fear-avoidance beliefs about physical activity and work, FABQ-PA and FABQ-W), physical fitness (trunk muscular endurance via Sorensen, Ito-Shirado, lateral plank, and Killy tests; trunk and hamstring mobility; isokinetic trunk flexor/extensor strength at 30°/s and 90°/s), pain intensity (Visual Analog Scale), and psychological well-being (GHQ-12).

Statistical analyses

Sample size was estimated a priori using G*Power for a repeated-measures ANOVA within-between interaction (2 groups, 4 timepoints, medium effect size f=0.25, α=0.05, power=0.70), yielding a minimum of 22 participants; 24 were enrolled to account for attrition. Given the small sample size and non-normal distributions, non-parametric tests were used: Wilcoxon signed-rank for intra-group comparisons, Mann-Whitney U for inter-group comparisons and Group × Time interactions on change scores. Effect sizes were reported as rank-biserial correlations. The Benjamini-Hochberg procedure was applied to control the false discovery rate. Missing data (2.4%) were imputed using last observation carried forward following intention-to-treat principles.

Registration note

This study was retrospectively registered on ClinicalTrials.gov. Registration was not performed prior to enrolment because the study was classified as non-interventional research under French legislation (Loi Jardé) and received ethics approval under that framework. The requirement for prospective registration under ICMJE criteria, which apply a broader definition of clinical trial including non-randomised controlled studies with prospective allocation, was identified only at the manuscript preparation stage. The outcomes registered correspond exactly to those defined a priori in the study protocol and reported in the resulting manuscript.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Raimbeaucourt, France, 59283
    • Centre Hélène Borel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Low back pain lasting more than three months (chronic low back pain)
• Previous treatment failure (e.g., ineffective physical therapy)
• For participants over 40 years of age: completion of a cardiovascular stress test to rule out any cardiovascular risk
• Aged 18 to 65 years
• Written informed consent provided prior to inclusion

Exclusion Criteria:

• Spinal or related surgery within the six months prior to entering the program
• Under 18 or over 65 years of age
• Previous participation in a similar multidisciplinary rehabilitation program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preparatory program followed by Functional Restoration Program (PFRP); Participants received a 12-week preparatory lifestyle-based intervention (PFRP) followed by the 4-week intensive Functional Restoration Program (FRP). The PFRP totaled 26 hours of therapeutic exposure, including a 2-hour initial assessment, weekly 2-hour supervised sessions at the Day Hospital, 4 hours dedicated to exercise learning, 2 hours of therapeutic education, and approximately 18 hours of autonomous practice at home (69% of total exposure). The PFRP was designed as a gradual preparation phase emphasizing patient autonomy and self-management skills. After completing the 12-week PFRP, participants entered the 4-week intensive FRP.	Behavioral: 12-week preparatory lifestyle-based physical activity program; A 12-week preparatory phase delivered in group format at the Day Hospital, totaling 26 hours of therapeutic exposure. The program included a 2-hour initial assessment, weekly 2-hour supervised sessions led by an Adapted Physical Activity Instructor, 4 hours dedicated to exercise learning, and 2 hours of therapeutic education. Approximately 18 hours of autonomous practice at home were prescribed (69% of total exposure). Supervised sessions, scheduled at the end of the day to accommodate working participants, comprised resistance training on weight machines at 60% of three-repetition maximum, mobilization and stretching, and cardiorespiratory training on an ergocycle. Therapeutic education addressed misconceptions about pain and self-management strategies. The exercise content mirrored that of the subsequent Functional Restoration Program.; Other Names: PFRP; Pre-Program; Preparatory phase
Active Comparator: Functional Restoration Program alone (FRP); Participants received the 4-week intensive Functional Restoration Program (FRP) alone, after an equivalent waiting period without structured intervention. The FRP comprised 117 hours of multidisciplinary care delivered in a group setting at the Day Hospital (34 hours of independent training and 76.5 hours of supervised sessions including group physiotherapy, occupational therapy, adapted physical activities, balneotherapy, and stretching). Four weekly therapeutic education sessions addressed pain perception, post-program physical activity planning, and exercise physiology.	Behavioral: 4-week intensive Functional Restoration Program; A 4-week intensive multidisciplinary program delivered in a group setting at the Day Hospital, totaling 117 hours. Independent training (34 hours, average 6-7 hours per day) included muscle strengthening on weight machines (6-10 sets of 10 repetitions at 60% of three-repetition maximum, recalibrated midway through the program) and cardiorespiratory endurance on an ergocycle (20 minutes at 50% resistance during an incremental submaximal test). Supervised sessions (76.5 hours) comprised group physiotherapy (mobility, progressive strengthening), occupational therapy (flexion/extension, rotations, load carrying), adapted physical activities (physical games followed by core strengthening routines from the third week), balneotherapy, and stretching. Four weekly therapeutic education sessions addressed pain perception, post-program physical activity planning, and exercise physiology.; Other Names: FRP; Functional Restoration Program; Programme de Restauration Fonctionnelle du Rachis (PRFR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sedentary behavior (ONAPS-SED)	Sedentary behavior measured by the Sedentary subscale of the French ONAPS Physical Activity Questionnaire (ONAPS-PAQ), expressed in minutes per week. This subscale captures habitual sedentary time and was selected a priori as a direct measure of the behavioral change targeted by the lifestyle-based intervention. ONAPS-SED was not administered at T2 because intensive hospitalization does not reflect habitual physical activity behavior; analyses therefore focused on the T0-T1 (preparatory phase / waiting period) and T0-T3 (overall) periods.	Baseline (T0), 12 weeks (T1, FRP entry / end of preparatory phase), and approximately 8 months post-baseline (T3, 4-month follow-up after FRP completion)
Change in impact of pain on Daily Activities (DALLAS-DA)	Functional impact of pain on Daily Activities measured by the DALLAS Pain Questionnaire (Daily Activities subscale), expressed as a percentage from 0% (no impact) to 100% (maximum impact). This subscale was selected a priori as a measure of functional autonomy in everyday life, in line with the lifestyle-based intervention's theoretical framework.	Baseline (T0), 12 weeks (T1, FRP entry), 16 weeks (T2, FRP exit), and approximately 8 months post-baseline (T3, 4-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional disability (EIFEL)	Functional disability related to low back pain measured by the EIFEL questionnaire (French validated version of the Roland-Morris Disability Questionnaire), ranging from 0 (no disability) to 24 (maximum disability).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in pain intensity (VAS)	Self-reported pain intensity over the last three days measured using a 10 cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (maximum pain), without distinction between types of pain (nociceptive, neuropathic, nociplastic, or mixed).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in psychological well-being (GHQ-12)	General psychological well-being measured by the General Health Questionnaire 12-item version (GHQ-12). Each item scored 1-4; total 12-48. Higher scores indicate poorer psychological well-being.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in DALLAS work and leisure activities (DALLAS-WLA)	Impact of pain on work and leisure activities (DALLAS Pain Questionnaire, Work/Leisure subscale), as a percentage from 0% (no impact) to 100% (maximum impact). Higher values indicate greater impact (worse).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)
Change in DALLAS anxiety/depression (DALLAS-A/D)	Impact of pain on anxiety and depression (DALLAS Pain Questionnaire, Anxiety/Depression subscale), 0% to 100%. Higher values indicate greater impact (worse).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)
Change in DALLAS social interest (DALLAS-SOC)	Impact of pain on social interest (DALLAS Pain Questionnaire, Social subscale), 0% to 100%. Higher values indicate greater impact (worse).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)
Change in total physical activity (ONAPS-TOT)	Total weekly physical activity (French ONAPS-PAQ), in minutes per week. Not administered at T2 (intensive hospitalization does not reflect habitual activity). Higher values indicate more activity.	Baseline (T0), 12 weeks (T1), ~8 months (T3)
Change in moderate-to-vigorous physical activity (ONAPS-MVPAI)	Moderate-to-vigorous physical activity intensity (French ONAPS-PAQ), in minutes per week. Not administered at T2. Higher values indicate more activity.	Baseline (T0), 12 weeks (T1), ~8 months (T3)
Change in fear-avoidance beliefs about physical activity (FABQ-PA)	Fear-Avoidance Beliefs Questionnaire, Physical Activity subscale (4 items), score 0-24. Higher scores indicate stronger (more deleterious) fear-avoidance beliefs (worse).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)
Change in fear-avoidance beliefs about work (FABQ-W)	Fear-Avoidance Beliefs Questionnaire, Work subscale (7 items), score 0-42. Higher scores indicate stronger (more deleterious) fear-avoidance beliefs (worse).	Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)
Change in finger-to-floor distance	Posterior chain flexibility (finger-to-floor distance test), in centimeters; best of three trials. Negative values = fingertips below foot level. Lower values indicate greater mobility.	Time Frame: Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3, 4-month follow-up)
Change in lateral trunk mobility	Lumbar lateral mobility: change in finger-to-floor distance between neutral standing and maximal lateral inclination, in centimeters; best of three trials. Higher values indicate greater lateral mobility.	Time Frame: Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3, 4-month follow-up)
Change in trunk rotation	Trunk axial rotation amplitude on a graduated device with pelvis stabilized, right and left, in degrees (0-90° per side); best of three trials. Higher values indicate greater rotational mobility.	Time Frame: Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3, 4-month follow-up)
Change in hamstring extensibility (popliteal angle)	Hamstring extensibility (knee-extension / popliteal angle test, hip flexed 90°): maximal knee-extension amplitude, in degrees; best of three trials. Higher values indicate greater extensibility.	Time Frame: Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3, 4-month follow-up)
Change in trunk extensor peak torque at 30°/s	Trunk extensor peak torque on a Contrex® dynamometer at 30°/s, gravity-corrected and normalized to body weight (Nm/kg); best of three maximal repetitions. Higher values indicate greater strength.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in trunk extensor peak torque at 90°/s	Trunk extensor peak torque on a Contrex® dynamometer at 90°/s, gravity-corrected and normalized to body weight (Nm/kg); best of three maximal repetitions. Higher values indicate greater strength.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in trunk flexor peak torque at 30°/s	Trunk flexor peak torque on a Contrex® dynamometer at 30°/s, gravity-corrected and normalized to body weight (Nm/kg); best of three maximal repetitions. Higher values indicate greater strength.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in trunk flexor peak torque at 90°/s	Trunk flexor peak torque on a Contrex® dynamometer at 90°/s, gravity-corrected and normalized to body weight (Nm/kg); best of three maximal repetitions. Higher values indicate greater strength.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in trunk flexor endurance (Ito-Shirado test)	Isometric endurance of trunk flexors (Ito-Shirado test), in seconds (0-180). Higher values indicate greater endurance.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in lateral trunk endurance (McGill side-bridge test)	Isometric endurance of lateral trunk muscles and hip abductors/adductors (McGill side-bridge test), per side, in seconds (0-180). Higher values indicate greater endurance.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in lower-limb static endurance (Killy test)	Static lower-limb endurance (Killy test: back to wall, hips and knees at 90°), in seconds (0-180). Higher values indicate greater endurance.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)
Change in trunk extensor endurance (Sorensen test)	Isometric endurance of trunk extensors (Sorensen test), in seconds (0-180). Test stopped after three posture corrections or unbearable pain. Higher values indicate greater endurance.	Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)

Collaborators and Investigators

• Sponsor: University of Artois
• Collaborators: Fondation Hopale; Centre Hélène Borel; Université de Lille - SHERPAS (URePSSS, ULR 7369)

Publications and helpful links

General Publications

• Steven C, Isabelle C, Aymeric M, Marine D, Isabelle R, Jean-Louis L, Claire T. Multidisciplinary rehabilitation of the spine: a prospective comparison of an autonomy-based versus supervised rehabilitation model. Ann Phys Rehabil Med. 2026 Apr 25;69(5):102127. doi: 10.1016/j.rehab.2026.102127. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sedentary Behavior; Lifestyle Intervention; Prehabilitation; Exercise Therapy; Adapted Physical Activity; Patient Empowerment; Functional Restoration Program; Fear-Avoidance Beliefs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Chronic Pain; Low Back Pain; Sedentary Behavior; Patient Participation
• Other Study ID Numbers: PFRP-FRP-CHB-2023; 2025-01-07/2025-51 (Other Identifier: CERNI, Université de Picardie Jules Verne (Ethics Committee approval number))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data underlying the published results will be available upon reasonable request to the corresponding author, subject to a signed data sharing agreement and compliance with applicable French and European data protection regulations (CNIL, GDPR). Direct and indirect identifiers will be removed; granular variables (e.g., exact age, professional status) may be coarsened to limit re-identification risk given the small sample size (n=24).
• IPD Sharing Time Frame: Starting six months after publication of the main results manuscript, and ending five years thereafter.
• IPD Sharing Access Criteria: Requests will be reviewed by the principal investigator. Access will be granted to qualified researchers proposing methodologically sound secondary analyses, conditional on signed data sharing agreement and institutional ethics approval where required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No