Home-based Cycling for People With Lumbar Spinal Stenosis

Официальное название

Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial

Обзор

The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

Подробное описание

Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly impairs functioning and health-related quality of life of elders, and has an important healthcare cost.

The 2 main treatment options for lumbar spinal stenosis are conservative or surgical treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.

The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.

Вмешательства

• Другое Home-based cycling program
  Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and * 1 supervised session of cycling aimed at explaining how to use the connected ergometric bicycle and at designing a personalized home-based cycling program * a 12-month home-based cycling program using connected ergometric bicycles which intensity and dose are self-determined * 3 phone or email contacts with a care provider to deliver positive feedbacks and encouragements
• Другое usual care
  A prescription of 6 sessions of outpatient physiotherapy

Первичные конечные точки

• Change in back-specific activity limitations [Срок оценки: 4 months after-randomization]

Вторичные конечные точки (7)

• Change in maximal walking distance [Срок оценки: 4 months post-randomization]
• Change in lumbar pain [Срок оценки: 4, 6 and 12 months post-randomization]
• Change in radicular pain [Срок оценки: 4, 6 and 12 months post-randomization]
• Change in the physical component of health-related quality of life [Срок оценки: 4, 6 and 12 months post-randomization]
• Change in lumbar spinal stenosis-specific activity limitations [Срок оценки: 4, 6 and 12 months post-randomization]
• Change in back-specific activity limitations [Срок оценки: 6 and 12 months post-randomization]
• Percentage of patients who undergo spinal surgery [Срок оценки: From baseline to 12 months post-randomization]

Критерии участия

Критерии включения

• age ≥ 50 year-old
• radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
• MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology

Критерии исключения

• inability to speak and/or read French language
• inability or refusal to perform ergometric bicycle at home
• patients already having an ergometric bicycle at home
• history of lumbar spine surgery in the previous 12 months
• cognitive disorders
• severe neurologic or vascular disorders involving the lower limbs
• contraindication to a rehabilitation program assessed by medical examination
• people under tutorship or curatorship
• protected adults

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Ap — Paris

Публикации

• Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefevre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23. No abstract available. PMID 31982599

Идентификаторы

NCT: NCT04075539 · P160147 · 2023-A00601-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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