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临床试验/NCT05375422
NCT05375422已完成不适用

Effects of the Strengthening and Stretching Protocol for Rheumatoid Arthritis in the Hands (SARAH) on Hand Function in Women With Rheumatoid Arthritis

Federal University of Espirito Santo1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
Hand function

研究概览

简要总结

The aim of this study is to analyze the effect of the SARAH protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (RA).

详细描述

The volunteers will perform the SARAH protocol exercises (brazilian portuguese version) along with the usual guidelines. To participate in the research, patients must be diagnosed with RA using disease-modifying antirheumatic medication for at least 3 months, and age equal to or older to 18 years. Participants with incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE) will be excluded from the study. The participants will be evaluated before and after the intervention regarding the variables: hand function (Michigan Hand Outcomes Questionnaire), pain (Brief Pain Inventory), handgrip strength (Jamar® manual dynamometer), quality of life (Euro Quality of Life Instrument-5D), functional capacity (Health Assessment Questionnaire), RA disease activity (DAS28). The SARAH group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement. Patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings. A total of 4 face-to-face meetings will be held during the 3-month follow-up. The program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients must be diagnosed with RA
  • using disease-modifying antirheumatic medication for at least 3 months
  • over 18 years old

排除标准

  • incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE)
  • diagnosis of another associated autoimmune disease
  • having undergone previous surgical procedures on the hands
  • having suffered a fracture in the joints of the upper limbs in the last six months
  • being a patient on the waiting list for orthopedic surgery of the upper limb
  • being pregnant.

结局指标

主要结局

Hand function

时间窗: 3 months

Michigan Hand Outcomes Questionnaire. A total of 37 items assess six domains: general hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction with hand function. The participant must score each item using Likert-type scales ranging from 1 to 5.

次要结局

  • Pain inventory(3 months)
  • Hand grip strength(3 months)
  • Healthy related quality of life(3 months)
  • Functional capacity(3 months)
  • Disease activity(3 months)

研究者

发起方
Federal University of Espirito Santo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samira Tatiyama Miyamoto, PhD

Professor

Federal University of Espirito Santo

研究点 (1)

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