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临床试验/NCT04055545
NCT04055545已完成不适用

12 Week High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects: a Randomized Single-blinded Feasibility Study

Cerini Tamara1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Adherence

研究概览

简要总结

The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.

详细描述

The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.

However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.

In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
29 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Oswestry disability index (ODI) Score ≥ 14%
  • •Low back pain for at least 3 months.
  • •Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
  • •Good understanding of German or English, written and spoken.
  • •Age between 29 - 69
  • •No or stopped physical therapy.

排除标准

  • •Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
  • •Known pregnancy.
  • •Previous low back spinal surgery in the last 2 years.
  • •Tumour, spinal stenosis, spinal fractures or radiculopathy.
  • •Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.

研究组 & 干预措施

MICT

Active Comparator

干预措施: MICT (Other)

HIIT

Active Comparator

干预措施: HIIT (Other)

结局指标

主要结局

Adherence

时间窗: 13 weeks

Difference in training adherence rate between HIIT and MICT. The adherence rate will be calculated in the amount of days a patient trained versus the total days they were scheduled to train.

次要结局

  • Enjoyability(13 week)
  • Number of Adverse Events & Dropout rate(13 weeks)
  • Recruited rate(3 months)
  • Willingness to continue the training(13 weeks)

研究者

发起方
Cerini Tamara
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cerini Tamara

Sponsor-Investigator

HES-SO Valais-Wallis

研究点 (1)

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