Feasibility of a Person-centred Digital Program Targeting Physical Activity in Spinal Stenosis Surgery

NCT05806593 | Completed

• 1 other identifier: Get Back
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Spinal stenosis is the most common cause of degenerative spinal surgery. The majority do not achieve the global recommendations for health-promoting physical activity before or after surgery. Patients with a low level of physical activity and a high degree of fear of movement are at an increased risk of poorer health outcomes after surgery. Increasing the number of steps per day is a way to increase physical activity, which in long term can lead to health benefits. In addition, a digital format is a way to increase the availability of physiotherapy to strive for equal rehabilitation. The overall purpose of the research project is to improve health outcome and increase the availability of rehabilitation for patients at high risk of negative health outcomes after spinal surgery due to spinal stenosis through Get Back, a person-centered and digital program with a focus on physical activity. Before conducting a large-scale study, the investigators want to conduct a study that aims to investigate and develop the Get Back program regarding content and dose, treatment fidelity as well as feasibility in terms of study procedure, compliance, and acceptability. Approximately thirty patients with lumbar spinal stenosis and an identified risk profile for poorer postoperative outcomes will be recruited from two spine clinics in Sweden. The program involves meeting a physiotherapist digitally (through video call) approximately 1 week before surgery to formulate a person-centered health plan. The health plan is monitored and progressed by the physiotherapist by video until eleven weeks after surgery. The Get Back program includes 5 sessions (1 hour each) which are supplemented with 5 booster sessions (30 minutes) to reinforce the intervention. Get Back is based on three key components that run through all sessions. These are person-centeredness, behavioral medicine techniques to reduce fear of movement and worries about pain, as well as to optimize physical activity. The physiotherapist supports the participant's individual resources and abilities through validated behavioral medicine methods in combination with education/communication/knowledge support and behavior-strengthening tools (which are also used in-between sessions) to achieve the participant's personal goals linked to physical functioning, physical activity, and health. The program will be compared to standard physiotherapy.

Conditions

Spinal Stenosis Lumbar

Keywords

Health promotion; Person-centred care; Physical activity; Behavioral medicine; Telehealth

Outcome Measures

Primary Outcomes (9)

• Change in variables related to intervention content.

  A questionnaire including 14 one-item questions aiming to capture steps per day (reported from a pedometer), self-reported physical activity level, and relevant aspects of pain catastrophizing, fear of movement and self-efficacy (on rating scales ranging from 0 to 10).

  Once a week during the 12-week study period.

• The intervention participants frequency and length of contact with the study physiotherapist.

  The data will be noted by the study physiotherapist on each session protocol.

  Continuously during the 12 week intervention.

• Checklist of included components at each treatment session.

  The treatment components addressed during each intervention session will be noted by the study physiotherapist on a checklist.

  Continuously during the 12 week intervention.

• Analysis of audio recordings from the intervention sessions.

  Audio recordings of the intervention sessions will be conducted and transcribed for post-hoc analysis by a third party (trained in person centredness and cognitive behavioural therapy) to ensure that the key components of the intervention are included.

  Continuously during the 12 week intervention.

• Type and frequency of possible adverse events.

  The type and frequency of possible adverse events during the intervention will be collected by the study physiotherapist and noted on each session protocol.

  Continuously during the 12 week intervention.

• Percentage of patients eligible after the screening procedure.

  The data will be noted on screeninglists.

  Through study completion, an average of 6 month.

• Number of intervention sessions attended out of planned.

  The data will be noted by the study physiotherapist on each session protocol.

  Through study completion for each intervention participant, an average of 12 weeks.

• Acceptability of data collection methods measured with a study specific questionnaire.

  Study specific questionnaires including questions related to experiences from participants and assessors of the methods used for data collection.

  At the end of each participants 12 week study period.

• Participants experiences of the intervention collected via telephone interviews.

  Semi structured telephone interviews with participants of the intervention group, which will be audio recorded and transcribed into text material.

  At the end of intervention/after 12 weeks.

Secondary Outcomes (14)

• Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).

  At baseline, and post-intervention/after 12 weeks

• Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).

  At baseline, and post-intervention/after 12 weeks

• Physical function measured with the Timed-up-and-go test (TUG).

  At baseline, and post-intervention/after 12 weeks

• Postural balance measured with the One Leg Stand test.

  At baseline, and post-intervention/after 12 weeks

• Functional leg strength measured with the 30 seconds sit-to-stand test.

  At baseline, and post-intervention/after 12 weeks

Study Arms (2)

Intervention (Get Back pilot)

EXPERIMENTAL

The intervention includes 5 core sessions (video call) and 5 booster sessions (telephone) over 12 weeks (1 week before until 11 weeks after surgery). All sessions will be led by a physiotherapist. 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-centred care. 2. To reduce the threat value of postoperative pain and increase the patient's knowledge about the biopsychosocial nature of pain and positive effects of physical activity. 3. To detect barriers for postoperative physical activity and to support the patient to gradually start increasing physical activity. 4. To increase approach behavior for physical activity and reduce avoidance behavior by confronting fears and move towards personal goals. 5. To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan.

Behavioral: Get Back pilot

Control (standard physiotherapy)

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 weekly from the control group.

Interventions

Get Back pilot BEHAVIORAL

A health-promoting program, targeting physical activity behavior, with a person-centred approach led by a physiotherapist digitally during 12 weeks.

Intervention (Get Back pilot)

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 (no fusion) due to central lumbar spinal stenosis
• reporting a low level of physical activity (do not meet WHO´s physical activity recommendations of minimum 150 min moderate intensity per week), and one of the following criteria at preoperative screening; fear of movement (Tampa Scale of Kinesiophobia (TSK) ≥ 37) and/or pain catastrophizing (Pain Catastrophizing Scale (PCS) \>30).

You may not qualify if:

• Patients with malignancy, severe neurological -or rheumatic disease, idiopathic scoliosis, isthmic spondylolisthesis
• not able to understand written information and communicate in Swedish

Sponsors & Collaborators

• Sophiahemmet University: lead
• The Swedish Research Council: collaborator
• AFA Insurance: collaborator

Study Sites (2)

Capio Spine Center Göteborg

Västra Frölunda, Gothenburg, 42130, Sweden

Location

Ryggkirurgiskt centrum Stockholm

Stockholm, Stockholm County, 11433, Sweden

Location

Related Publications (1)

• Karlsson E, Hanafi R, Brisby H, Fors A, Kemani M, Hedman H, Nijs J, Lundberg M. Get Back, a person-centred digital programme targeting physical activity for patients undergoing spinal stenosis surgery-a study protocol of a randomized feasibility study. Pilot Feasibility Stud. 2024 Jan 26;10(1):16. doi: 10.1186/s40814-023-01433-9.

  PMID: 38279131 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mari K Lundberg

  Sophiahemmet Högskola

  PRINCIPAL INVESTIGATOR

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: March 11, 2023
• First Posted: April 10, 2023
• Study Start: April 17, 2023
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)