Preparatory Lifestyle Program Before Functional Restoration for Chronic Low Back Pain

NCT07649707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Centre Hélène Borel

    collaborator UNKNOWN
  • Fondation Hopale

    collaborator UNKNOWN
  • Université de Lille - SHERPAS (URePSSS, ULR 7369)

    collaborator UNKNOWN
  • University of Artois

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649707 on ClinicalTrials.gov