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.
Patients planned for decompression surgery due to central lumbar spinal stenosis
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.
Parallel
Get Back
BehavioralA rehabilitation program, targeting physical activity behavior, with a person-centered approach led by a physical therapist during 12 weeks (1 week before surgery until 12 weeks after surgery) in a digital format.
Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
Reported as number of steps per day. The primary endpoint is 3 months postoperatively.
Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).
Reported as time spent in light physical activity, moderate to vigorous physical activity (MVPA) and time spent sedentary.
Physical function measured with the Timed-up-and-go test (TUG).
The time it takes for a participant to rise from a chair, walk 3 meters, turn, walk back to the chair and sit down. Reported in seconds.
Postural balance measured with the One Leg Stand test.
The time a participant can stand on one leg, reported in seconds.
Functional leg strength measured with the 30 seconds sit-to-stand test.
Reported as the number of chair rises a participant can complete during 30 seconds.
Direct costs, indirect costs and productivity losses collected with a self-report questionnaire.
Data for the health economic evaluation. A questionnaire including 10 questions (as well as subsections) aiming to capture costs from a societal perspective including direct costs (consultations, medical use, hospital stays), indirect (transportation), and productivity losses (sick leave) based on participants self-report. Treatment adherence and trial treatment costs, including education, the digital platform, and intervention materials, will be collected by the study physical therapist.
Health related quality of life collected with the EuroQol five dimension scale (EQ-5D 3L)
Data for the health economic evaluation. Reported as an index utility score between 0 to 1 (a higher score indicates better health state) and a visual analogue scale of self-related overall health ranging from 0 to 100 (a higher score indicates better overall health).
Participants experiences of the intervention content collected via telephone interviews.
Semi structured telephone interviews with participants from the intervention group, which will be audio recorded and transcribed into text material.
Patient perceptions of person-centered care rated with the Generic Person-Centered Care Questionnaire (GPCCQ).
The questionnaire involves 18 questions answered on a 5-point scale where 1 ="No, not at all", and 5="Yes, completely". A higher scores mean a higher perception of person-centered care being present in the care.
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Sophiahemmet University
Lead sponsor
The Swedish Research Council
Collaborator
Göteborg University
Collaborator
