Get Back, A Digital Person-Centered Rehabilitation Program to Increase Physical Activity After Lumbar Spinal Stenosis Surgery - a Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients planned for decompression surgery due to central lumbar spinal stenosis

Locations
Other Locations
Sweden
Ryggkirurgiskt centrum Stockholm
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
Akademiska sjukhuset
NOT_YET_RECRUITING
Uppsala
Capio Spine Center Göteborg
RECRUITING
Västra Frölunda
Contact Information
Primary
Mari K Lundberg
mari.lundberg@shh.se
+46 8-406 20 91
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 252
Treatments
Experimental: 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:~1. To establish the patient as an active, equal partner in the treatment and to formulate a shared health plan according to person-centered care.~2. To follow up with postoperative analysis and activity initiation.~3. To support graded physical activity by analysis, problem-solving, and behavioral strategies.~4. To support graded physical activity by analysis, problem-solving, and behavioral strategies.~5. To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Gothenburg Center for Person-Centred Care, GPCC, The Swedish Research Council
Leads: Sophiahemmet University

This content was sourced from clinicaltrials.gov