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Идёт набор NCT06921694

A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain

Без фазы С лечением Low Back Pain, Chronic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Runner group, Swim/Cycle Group.
Кому может быть актуально
Состояния в реестре: Low Back Pain, Chronic. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study

Обзор

This randomised controlled trial will evaluate the effectiveness of different exercise modalities for individuals with low back pain. Participants will be allocated to one of three groups: a control arm (usual exercise), a running-based intervention, or a swimming/cycling-based intervention. Outcomes related to pain and function will be measured at baseline, 8 weeks, and 12 months.

Подробное описание

This study is designed to assess the impact of structured exercise interventions on pain and functional outcomes in otherwise healthy adults with low back pain. Eligible participants recruited from the community will be randomised into one of three arms: (1) control group, continuing their usual exercise activities; (2) running intervention group; or (3) swimming/cycling intervention group.

The two intervention arms will complete an 8-week combined exercise programme consisting of aerobic training (running or swimming/cycling, depending on group assignment), progressive resistance training, and prescribed flexibility exercises. The programme is structured to gradually increase in intensity over the 8-week period to enhance adherence and minimize risk of injury.

Efficacy will be evaluated using validated patient-reported outcome measures (PROMs) capturing pain intensity and functional capacity. These assessments will be administered at three time points: baseline (prior to the intervention), post-intervention (8 weeks), and long-term follow-up (12 months). This design will enable analysis of both the short-term and sustained effects of exercise modality on low back pain management.

Вмешательства

  • Поведенческое Runner group
    The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running), a schedule of gradually intensifying strengthening exercises and flexibility exercises
  • Поведенческое Swim/Cycle Group
    The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises

Первичные конечные точки

  • VAS pain score [Срок оценки: Baseline, 8 weeks, 12 months]
Вторичные конечные точки (2)
  • Oswestry disability index [Срок оценки: Baseline, 8 weeks, 12 months]
  • Roland Morris Disability questionnaire [Срок оценки: Baseline, 8 weeks, 12 months]

Критерии участия

Критерии включения

  • Aged 18-45 years
  • Participant is willing and able to give informed consent for participation in the study
  • Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)
  • Suffers from pain or functional limitations as a result of their LBP (minimum VAS (back) score of 3/10 or ODI score of at least 5/50 or RMD score of at least 5/24 (note, unlike ODI, RMD does not describe specific cuts offs for different levels of disability)
  • Able to exercise

Критерии исключения

  • Radiating pain to leg / sciatica / acute radiculopathy
  • Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal stenosis, spinal tumour, facet joint damage)
  • History of osteoporosis , arthritis, scoliosis, or kyphosis.
  • Current spinal infection, cancer or a current fracture (any bone).
  • History of spinal/back surgery
  • Unable to participate in physical activity and exercise
  • Pregnant or breast feeding
  • History of substance abuse
  • History of psychiatric illness (eg. depression, dementia, schizophrenia) for which currently taking medication
  • History or current neurological condition (e.g. epilepsy)
  • Not in possession or have access to adapted equipment (phone, computer, functioning WIFI)
  • Unable to understand and communicate in English
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • University of Nottingham, Queen's Medical Centre — Nottingham

Идентификаторы

NCT: NCT06921694 · FMHS 279 0423

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗