Preparatory Lifestyle Program Before Functional Restoration for Chronic Low Back Pain

NCT07649707 | Completed

• 2 other identifiers: PFRP-FRP-CHB-20232025-01-07/2025-51
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Chronic Pain

Keywords

Functional Restoration Program; Adapted Physical Activity; Lifestyle Intervention; Prehabilitation; Patient Empowerment; Sedentary Behavior; Fear-Avoidance Beliefs; Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Change in functional disability (EIFEL)

  Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)

• Change in pain intensity (VAS)

  Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)

• Change in psychological well-being (GHQ-12)

  Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3)

• Change in DALLAS work and leisure activities (DALLAS-WLA)

  Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)

• Change in DALLAS anxiety/depression (DALLAS-A/D)

  Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3)

Study Arms (2)

Preparatory program followed by Functional Restoration Program (PFRP)

EXPERIMENTAL

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

Functional Restoration Program alone (FRP)

ACTIVE COMPARATOR

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

Interventions

4-week intensive Functional Restoration Program BEHAVIORAL

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.

Also known as: FRP; Functional Restoration Program; Programme de Restauration Fonctionnelle du Rachis (PRFR)

Functional Restoration Program alone (FRP)

12-week preparatory lifestyle-based physical activity program BEHAVIORAL

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.

Also known as: PFRP; Pre-Program; Preparatory phase

Preparatory program followed by Functional Restoration Program (PFRP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hélène Borel

Raimbeaucourt, 59283, France

Location

Related Publications (1)

• 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.

  PMID: 42035666 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Patient Participation; Sedentary Behavior

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Health Sciences, Principal Investigator

Model Details: Two-arm parallel-group controlled study. Group allocation was determined by admission scheduling and the residential program's organizational constraints (groups of 2 to 6 patients per admission cycle). Identical inclusion and exclusion criteria were applied to both groups to limit selection bias. Baseline comparability across all 28 measured variables (all p \> 0.05) was verified.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 16, 2026
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting six months after publication of the main results manuscript, and ending five years thereafter.
• 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.

Locations

FR (1)