Evaluation of a Digital Person-Centered Rehabilitation Program Targeting Physical Activity in Spinal Stenosis Surgery (Get Back)

NCT06935201 | Recruiting

• 1 other identifier: Get Back RCT
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Spinal Stenosis Lumbar

Keywords

Rehabilitation; Person-centred care; Physical activity; Steps per day; Behavioral medicine; Telerehabilitation; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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.

  At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up

Secondary Outcomes (11)

• 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.

Other Outcomes (4)

• Direct costs, indirect costs and productivity losses collected with a self-report questionnaire.

  At 6 weeks, 3, 6 and 12 months postoperative follow-up.

• Health related quality of life collected with the EuroQol five dimension scale (EQ-5D 3L)

  At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.

• Participants experiences of the intervention content collected via telephone interviews.

  At 3 month postoperative follow-up (post-intervention).

Study Arms (2)

Intervention (Get Back)

EXPERIMENTAL

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.

Behavioral: Get Back

Control (standard physical therapy)

NO INTERVENTION

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.

Interventions

Get Back BEHAVIORAL

A 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.

Intervention (Get Back)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sophiahemmet University: lead
• The Swedish Research Council: collaborator
• Göteborg University: collaborator

Study Sites (4)

Ryggkirurgiskt centrum Stockholm

Stockholm, 11433, Sweden

RECRUITING

Södersjukhuset

Stockholm, 11861, Sweden

RECRUITING

Akademiska sjukhuset

Uppsala, 75185, Sweden

RECRUITING

Capio Spine Center Göteborg

Västra Frölunda, 42130, Sweden

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mari K Lundberg

  Sophiahemmet University/Sophiahemmet Högskola

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari K Lundberg

CONTACT

+46 8-406 20 91; mari.lundberg@shh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)