A Preparatory Lifestyle-Based Physical Activity Intervention Before Intensive Rehabilitation for Chronic Low Back Pain: A Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in sedentary behavior (ONAPS-SED)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 12-week preparatory lifestyle-based physical activity program (Behavioral)
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.
干预措施: 4-week intensive Functional Restoration Program (Behavioral)
结局指标
主要结局
Change in sedentary behavior (ONAPS-SED)
时间窗: 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)
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.
Change in impact of pain on Daily Activities (DALLAS-DA)
时间窗: Baseline (T0), 12 weeks (T1, FRP entry), 16 weeks (T2, FRP exit), and approximately 8 months post-baseline (T3, 4-month follow-up)
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.
次要结局
- 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))
- Change in DALLAS social interest (DALLAS-SOC)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3))
- Change in total physical activity (ONAPS-TOT)(Baseline (T0), 12 weeks (T1), ~8 months (T3))
- Change in moderate-to-vigorous physical activity (ONAPS-MVPAI)(Baseline (T0), 12 weeks (T1), ~8 months (T3))
- Change in fear-avoidance beliefs about physical activity (FABQ-PA)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3))
- Change in fear-avoidance beliefs about work (FABQ-W)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), ~8 months (T3))
- Change in finger-to-floor distance(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(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(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)(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(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in trunk extensor peak torque at 90°/s(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in trunk flexor peak torque at 30°/s(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in trunk flexor peak torque at 90°/s(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in trunk flexor endurance (Ito-Shirado test)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in lateral trunk endurance (McGill side-bridge test)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in lower-limb static endurance (Killy test)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
- Change in trunk extensor endurance (Sorensen test)(Baseline (T0), 12 weeks (T1), 16 weeks (T2), and approximately 8 months post-baseline (T3))
研究者
Steven Crombecque
Doctor in Health Sciences, Principal Investigator
University of Artois