Physical Activity in the Elderly Spine Patient

NCT04079894 | Completed

• 2 other identifiers: OP_88420182000-128
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose Physical activity reduces the risk of several diseases of the body and the mind1, 2 and can help the elderly maintain physical abilities and self-efficacy in daily life1. The overall purpose of the project is to provide clinicians with a tool to objectively assess physical activity in daily life and thus provide an informed basis for individualized care of elderly patients with spine disease. We would like to introduce this tool to a broad population of elderly patients with low back pain to give an overview of the range and variability in physical activity. We will also look into a method for accurate step count in spine disorders where patients have severe walking impairment due to affected lumbar nerve roots.

Conditions

Lumbar Spinal Stenosis; Low Back Pain

Keywords

Accelerometry; Walking; Physical Activity; Sedentary time

Outcome Measures

Primary Outcomes (8)

• Accelerometer-data

  Raw accelerometer data will be collected by four accelerometers (Axivity AX3. ), which will be placed at the participants' hip in the midaxillary line, at the thigh, ankle and on the lower back, secured by hypo-allergenic band aids.

  Collected during the Standardized Movement Protocol at baseline.

• Accelerometer-data

  Raw accelerometer data collected for 7 consecutive days, by one accelerometer (Axivity AX3) secured by band-aid. The placement of the accelerometer will be decided in phase A.

  At baseline

• Accelerometer-data

  Raw accelerometer data collected for 7 consecutive days, by one accelerometer (Axivity AX3) secured by band-aid. The placement of the accelerometer will be decided in phase A.

  3 months post-surgery

• The Self-Paced Walking Test

  Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked.

  At baseline as part of the Standardized Movement Procotol

• The Self-Paced Walking Test

  Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked.

  At baseline

• The Self-Paced Walking Test

  Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked.

  3 months post-surgery

• The Oswestry Disability Index

  Questionnaire on function in patients with lower back pain. Score 0-100% where 100% is severe disability

  At baseline

• The Oswestry Disability Index

  Questionnaire on function in patients with lower back pain. Score 0-100% where 100% is severe disability

  3 months post-surgery.

Secondary Outcomes (10)

• The Swiss Spinal Stenosis Questionnaire

  At baseline

• The Swiss Spinal Stenosis Questionnaire

  3 months post-surgery

• Visual Analog Scale for Back and Leg Pain

  At baseline

• Visual Analog Scale for Back and Leg Pain

  3 months post-surgery

• Hospital Anxiety and Depression Scale

  At baseline

Study Arms (3)

LSS Participants

Patients with lumbar spinal stenosis

Other: Standard Movement Protocol; Device: Accerelerometer Monitoring

Background population

Populationdata from existing research project

Device: Accerelerometer Monitoring

LBP Participants

Patients with Low back Pain

Device: Accerelerometer Monitoring

Interventions

Standard Movement Protocol OTHER

Participant walking, cycling and sitting according to a pre-specified protocol.

LSS Participants

Accerelerometer Monitoring DEVICE

7 days of accelerometer monitoring in participants home-environment.

Background population; LBP Participants; LSS Participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients with LSS on a degenerative basis, age \>=60, referred to the spine center by primary or secondary health care, in the Region of Southern Denmark. Patients with Low Back Pain will be included from three chiropractic clinics in the Region of Southern Denmark. Healthy participants will be identified among hospital staff, acquaintances and participating patients' spouse/acquaintances.

You may qualify if:

• Informed written consent.
• Fluent in Danish in reading and speaking.
• Age \>60 with LSS, +/- spondylolisthesis diagnosed via clinical examination and MRI. Suffering from neurogenic claudication with positive answers to a set of six items characteristic to LSS\[29\].
• Patients in phase A will be included to represent a spectrum of severeness of LSS and age. Severeness will be evaluated by ODI score, VAS and self-reported maximum walking distance.

You may not qualify if:

• Other disease limiting walking rather than neurogenic claudication, such as cardiopulmonary diseases, vascular claudication, recent operation or fracture of spine, pelvis or leg, severe hip or knee arthrosis (not efficiently threated by hip/knee replacement), systemic muscular diseases, impaired vision.
• Traits which interfere with the participants' gait pattern, such as habitual use of walking aids during walking at home and away from home, drop foot.
• Eligibility Criteria for Patients with LBP:
• Informed written consent.
• Fluent in Danish in reading and speaking.
• Age \>60
• Suffering from Low Back Pain
• Low Back Pain is the primary source of pain and disability.
• Eligibility Criteria for Healthy Participants:

Sponsors & Collaborators

• Malin Eleonora av Kák Gustafsson, MD: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (11)

• Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.

  PMID: 26727925 BACKGROUND

• Ammendolia C, Stuber K, Tomkins-Lane C, Schneider M, Rampersaud YR, Furlan AD, Kennedy CA. What interventions improve walking ability in neurogenic claudication with lumbar spinal stenosis? A systematic review. Eur Spine J. 2014 Jun;23(6):1282-301. doi: 10.1007/s00586-014-3262-6. Epub 2014 Mar 15.

  PMID: 24633719 BACKGROUND

• Norden J, Smuck M, Sinha A, Hu R, Tomkins-Lane C. Objective measurement of free-living physical activity (performance) in lumbar spinal stenosis: are physical activity guidelines being met? Spine J. 2017 Jan;17(1):26-33. doi: 10.1016/j.spinee.2016.10.016. Epub 2016 Oct 25.

  PMID: 27793759 BACKGROUND

• Henrica C. W. de Vet CBT, Lidwine B. Mokkink, Dirk L. Knol (2011) Measurement in Medicine A Practical Guide

  BACKGROUND

• Jespersen AB, Gustafsson MEAK. Correlation between the Oswestry Disability Index and objective measurements of walking capacity and performance in patients with lumbar spinal stenosis: a systematic literature review. Eur Spine J. 2018 Jul;27(7):1604-1613. doi: 10.1007/s00586-018-5520-5. Epub 2018 Mar 5.

  PMID: 29508075 BACKGROUND

• Tomkins CC, Battie MC, Rogers T, Jiang H, Petersen S. A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine (Phila Pa 1976). 2009 Oct 15;34(22):2444-9. doi: 10.1097/BRS.0b013e3181b03fc8.

  PMID: 19829259 BACKGROUND

• Webber SC, St John PD. Comparison of ActiGraph GT3X+ and StepWatch Step Count Accuracy in Geriatric Rehabilitation Patients. J Aging Phys Act. 2016 Jul;24(3):451-8. doi: 10.1123/japa.2015-0234. Epub 2016 Jan 11.

  PMID: 26751505 BACKGROUND

• Treacy D, Hassett L, Schurr K, Chagpar S, Paul SS, Sherrington C. Validity of Different Activity Monitors to Count Steps in an Inpatient Rehabilitation Setting. Phys Ther. 2017 May 1;97(5):581-588. doi: 10.1093/ptj/pzx010.

  PMID: 28339904 BACKGROUND

• McCullagh R, Dillon C, O'Connell AM, Horgan NF, Timmons S. Step-Count Accuracy of 3 Motion Sensors for Older and Frail Medical Inpatients. Arch Phys Med Rehabil. 2017 Feb;98(2):295-302. doi: 10.1016/j.apmr.2016.08.476. Epub 2016 Sep 22.

  PMID: 27666157 BACKGROUND

• Dijkstra B, Kamsma Y, Zijlstra W. Detection of gait and postures using a miniaturised triaxial accelerometer-based system: accuracy in community-dwelling older adults. Age Ageing. 2010 Mar;39(2):259-62. doi: 10.1093/ageing/afp249. Epub 2010 Jan 18. No abstract available.

  PMID: 20083616 BACKGROUND

• Park J, Ishikawa-Takata K, Tanaka S, Bessyo K, Tanaka S, Kimura T. Accuracy of Estimating Step Counts and Intensity Using Accelerometers in Older People With or Without Assistive Devices. J Aging Phys Act. 2017 Jan;25(1):41-50. doi: 10.1123/japa.2015-0201. Epub 2016 Aug 24.

  PMID: 27180730 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Malin EK Gustafsson, M.D

  Spine Centre of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D.-student

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: September 6, 2019
• Study Start: June 26, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Will be made available to scientific journals upon request, in anonymous form, for 6 months from request.
• Access Criteria: IPD will be made available in connection to anticipated publication, to the publishing scientific journal, when required by the journal to ensure scientific integrity.

Locations

DK (1)