Status:
COMPLETED
Physical Activity in the Elderly Spine Patient
Lead Sponsor:
Malin Eleonora av Kák Gustafsson, MD
Collaborating Sponsors:
University of Southern Denmark
Conditions:
Lumbar Spinal Stenosis
Low Back Pain
Eligibility:
All Genders
60+ years
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 o...
Detailed Description
Background Spine disorders, such as low back pain, come with considerable physical limitations, and participation in social events and everyday life can be burdensome2. Efforts to increase physical ab...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients with LSS:
- 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.
- Patients for phase C will have the additional inclusion criteria of being scheduled for decompressive surgery.
- Exclusion Criteria:
- 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:
- \- Healthy participants will be \>60 years old and have the same exclusion criteria as patients, with the addition of not suffering from neurogenic claudication.
Exclusion
Key Trial Info
Start Date :
June 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04079894
Start Date
June 26 2019
End Date
February 1 2023
Last Update
March 16 2023
Active Locations (1)
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1
Spine Centre of Southern Denmark
Middelfart, Denmark, 5500