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临床试验/CTRI/2025/09/094911
CTRI/2025/09/094911尚未招募不适用

Association between sleep problems, disease activity, and upper limb dysfunction in patients with rheumatoid arthritis.

College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
SLEEP PROBLEMS

研究概览

简要总结

This study will be conducted on patients diagnosed with rheumatoid arthritis (RA) as per the 2010 ACR/EULAR criteria, referred from the OPD of the Department of Rheumatology, PGIMS, UHS Rohtak. Eligible participants will be adults (>18 years) with disease duration >1 year. Patients with other autoimmune diseases, severe comorbidities, neurological disorders, recent upper extremity injuries, sleep disorders, or medications affecting sleep will be excluded. Data collection will include demographic details, sleep quality (Pittsburgh Sleep Quality Index), disease activity (DAS28-ESR), and upper limb dysfunction (DASH questionnaire). Written informed consent will be obtained, and data will be collected in a structured and confidential manner.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed patients of Rheumatoid Arthritis fulfilling 2010 ACR EULAR Criteria Disease duration more than 1 year.

排除标准

  • Other autoimmune diseases, severe comorbidities (eg diabetes, cardiovascular).
  • Recent upper extremity injury.
  • Sleep disorders or medications affecting sleep (eg sedatives, corticosteroids).
  • Neurological disorders.

结局指标

主要结局

SLEEP PROBLEMS

时间窗: On Day 0 (Baseline)

DISEASE ACTIVITY

时间窗: On Day 0 (Baseline)

UPPER LIMB DYSFUNCTION

时间窗: On Day 0 (Baseline)

次要结局

未报告次要终点

研究者

发起方
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anjali Sharma

College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

研究点 (1)

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