Get Back, A Digital Person-Centered Rehabilitation Program to Increase Physical Activity After Lumbar Spinal Stenosis Surgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 4
- 主要终点
- Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
研究概览
简要总结
This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.
详细描述
The Get Back rehabilitation program has been developed using the Medical Research Councils (MRC) framework. A feasibility study (NCT05806593) has been completed involving 29 patients (mean age 67) who underwent surgery for LSS. The Get Back intervention (completely digital i.e. assessments and rehabilitation) was shown to be feasible and resulted in clinically significant improvements in daily steps at 12 weeks' post-surgery.
To evaluate the effectiveness and process of Get Back a multicenter randomized controlled trial including three sub-studies will be conducted. The specific research questions we aim to investigate in this RCT are:
- if Get Back is more effective than standard rehabilitation in increasing daily steps (primary outcome) and physical activity behavior, disability, or pain-related factors (secondary outcomes) after surgery for LSS
- if Get Back is more cost effective than standard rehabilitation after surgery for LSS
- how baseline values (psychological factors, physical capacity and physical activity) predict changes in daily steps after surgery for LSS
- how participants' experiences contribute to an enhanced understanding of what impact the intervention content had on their physical activity behavior.
Patients will be recruited from four clinical study sites (two private spine clinics and two hospitals). All patients undergo a clinical examination by an orthopedic surgeon as part of standard preoperative care. If a surgical decision is made and the patient is placed on the waiting list, a local recruiter at each site will hand out written study information to the patients meeting inclusion criteria and ask if a physical therapist from the study can make contact to provide further information about the study and ask for participation. As the intervention is fully digital, the patient information in written will also be sent to the patient digitally.
At baseline (approx. 2 weeks pre-surgery), participants meet with an assessor (physical therapist) via a digital care platform for collection of demographic data, personal goals, and to conduct physical capacity tests. Questionnaires are sent out through a digital application and patients wear an accelerometer for 7 days sent out by mail. Outcome variables are described more in detail under the heading Outcome Measures in the trial registration. The follow-ups are scheduled at 6 weeks, 3 months, 6 months, and 1-year post-surgery. Accelerometry and questionnaires will be collected at each follow-up, whereas physical capacity tests will be conducted at 3 and 12 months post-surgery. Clinical data such as type of surgery, complications, discharge destination will be collected from the patients' medical records at 3 months post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for decompression surgery due to central lumbar spinal stenosis
排除标准
- •Patients with malignancy under treatment or with metastases;
- •History of neurological or other disorders resulting in severe movement dysfunction;
- •Untreated or instable heart conditions that prohibits physical tests;
- •Poor understanding of Swedish.
研究组 & 干预措施
Control (standard physical therapy)
The control group will follow standard physical therapy, meaning physical therapy as it is provided at each recruiting site when undergoing surgery due to spinal stenosis. As this may differ substantially between clinical sites nationally, data on frequency of physical therapy and the content of the physical therapy sessions during the study period will be collected as a control variable from the control group.
Intervention (Get Back)
The intervention includes up to 5 core sessions (video call) and 5 booster sessions (telephone) over 13 weeks (approx. 1 week before until 12 weeks after surgery). All sessions will be led by a physical therapist. The focus of each core session (1-5) is as follows:
- To establish the patient as an active, equal partner in the treatment and to formulate a shared health plan according to person-centered care.
- To follow up with postoperative analysis and activity initiation.
- To support graded physical activity by analysis, problem-solving, and behavioral strategies.
- To support graded physical activity by analysis, problem-solving, and behavioral strategies.
- To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan.
干预措施: Get Back (Behavioral)
结局指标
主要结局
Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
时间窗: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Reported as number of steps per day. The primary endpoint is 3 months postoperatively.
次要结局
- Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up)
- Physical function measured with the Timed-up-and-go test (TUG).(At preoperative baseline, 3 and 12 months postoperative follow-up.)
- Postural balance measured with the One Leg Stand test.(At preoperative baseline, 3 and 12 months postoperative follow-up.)
- Functional leg strength measured with the 30 seconds sit-to-stand test.(At preoperative baseline, 3 and 12 months postoperative follow-up.)
- Pain intensity level in the leg and back reported with the Numeric Rating Scale (NRS).(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.)
- Self-reported back-related disability collected with the Oswestry Disability Index (ODI).(At preoperative baseline, 3 and 12 months postoperative follow-up.)
- The person's own goals regarding function collected with the Patient Specific Functional Scale (PSFS).(At preoperative baseline, 3 and 12 months postoperative follow-up.)
- Catastrophizing thoughts related to pain collected with the Pain Catastrophizing Scale (PCS).(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up)
- Patient-reported kinesiophobia collected with the Swedish version of the Tampa Scale of Kinesiophobia (TSK-SV).(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.)
- Depressed mood collected with the depression subscale of the Hospital Anxiety and Depression Scale.(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.)
- Pain self-efficacy collected with the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2).(At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.)
研究者
Mari Lundberg
Professor
Sophiahemmet University