跳至主要内容
临床试验/NCT07467499
NCT07467499招募中不适用

Impact of Leisure Activities on Quality of Life in Patients With Chronic Low Back Pain

Centre Hospitalier Valida4 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
148
试验地点
4
主要终点
Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

研究概览

简要总结

Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Diagnosis of chronic low back pain by a physician, defined as pain located in the lumbar region (between the lower edge of the sides and the gluteal fold) that is persistent or recurrent for at least 12 weeks.
  • Ability to complete questionnaires in French, informed consent.
  • Signed informed consent before any participation in the study.

排除标准

  • Recent lumbar surgery (< 6 months) or current surgical indication.
  • Severe neurological condition (stroke, neurodegenerative diseases, head injury, etc.), active cancer, pregnancy.
  • Severe psychiatric condition.
  • Participation in another clinical trial within the last 6 months.
  • Inability to understand French or to complete the questionnaires independently.
  • Refusal to participate.
  • Refusal to sign the informed consent form.

研究组 & 干预措施

patients with chronic low back pain

干预措施: Questionnaires (Other)

结局指标

主要结局

Spearman rank correlation between leisure activity level assessed by Nottingham Leisure Questionnaire and quality of life assessed by Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)

时间窗: at inclusion

次要结局

  • Nottingham Leisure Questionnaire(at inclusion)
  • Simple Physical Activity Questionnaire (SIMPAQ)(at inclusion)
  • Leisure Motivation Scale (LMS-28)(at inclusion)
  • Hospital Anxiety and Depression Scale (HADS)(at inclusion)
  • Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)(at inclusion)
  • Oswestry Disability Index (ODI)(at inclusion)

研究者

发起方
Centre Hospitalier Valida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samar HATEM

Co-investigator

Centre Hospitalier Valida

研究点 (4)

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