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The Role of Isometric in Individuals With Rheumatoid Arthritis

2026年6月26日 更新者:Zülal TATAR

The Role of Isometric Exercise on Pain Modulation and Muscle Oxygenation in Individuals With Rheumatoid Arthritis

The aim of this study is to investigate the acute effects of isometric exercise on pain modulation and muscle oxygenation in individuals with rheumatoid arthritis.

研究概览

地位

邀请报名

干预/治疗

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Eligibility Criteria:
  • Diagnosis of rheumatoid arthritis
  • Being between 18-65 years of age
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a neurological disease
  • Having pulmonary or cardiovascular problems that may affect daily living activities
  • Sensory system disorders
  • Previous upper extremity surgery
  • Having cognitive impairment
  • Having an accompanying rheumatic disease
  • Fracture, dislocation, or surgical intervention in the hand/wrist region within the last 6 months
  • Communication limitations that prevent following the study protocol
  • Having an exercise history in the last six months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:控制组
有源比较器:Execise group
To determine isometric exercise intensity, a maximum repetition will be calculated individually using a handheld dynamometer. One maximum repetition will be defined as the highest value among the trials where participants squeezed the handheld dynamometer as hard as possible for 5 seconds. The average of 3 repetitions will be taken to determine one maximum repetition, with a 1-2 minute rest period between each repetition. 30% of one maximum repetition will be determined. The exercise will begin five minutes after this stage. During the exercise task, participants will squeeze the dynamometer at 30% of one maximum repetition for 3 consecutive minutes, adjusting the applied force as needed to maintain the desired strength level.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Temporal Summation Measurement
大体时间:Day 1
Ten stimuli of pressure pain threshold size will be applied to the volar (palm side) region of the non-dominant forearm using a pressure algometer. The difference between the first and tenth stimuli will be recorded. The pain level during the first and tenth stimuli will also be recorded according to GAS. The difference will be calculated.
Day 1
Visual Analog Scale (VAS) - Pain
大体时间:Day 1
The VAS is a 10 cm long scale drawn horizontally or vertically, starting with "No pain" and ending with "Unbearable pain." The patient is instructed to mark a point on this line corresponding to the intensity of their pain. The distance from the lowest VAS level to the patient's mark is measured with a ruler and recorded in centimeters.
Day 1
Pain Tolerance Assessment
大体时间:Day 1
Gradual pressure will be applied to the volar (palm side) region of the non-dominant forearm using a pressure gauge (initial intensity-0 kPa, rate-30 kPa/s, 3 repetitions, interval between stimuli-45 seconds). The maximum pressure that participants can tolerate will be recorded as the pressure is increased. The average of 3 consecutive measurements will be taken. The tip of the gauge will be shifted 0.5 cm between repetitions to avoid changes in skin sensitivity. Pain was assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm horizontal line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Total scores range from 0 to 10, with higher scores indicating greater pain severity (worse outcome).
Day 1
Pressure Pain Threshold Assessment
大体时间:Day 1
Based on the modified limits method, a pressure algometer will be used to apply gradual pressure to the volar (palm-side) region of the non-dominant forearm (initial intensity-0 kPa, velocity-30 kPa/s, 3 repetitions, interval between stimuli-45 seconds). Participants will inform the investigator when they first perceive pain. The pressure pain threshold will be taken as the average of 3 consecutive measurements. The algometer tip will be shifted 0.5 cm between repetitions to avoid changes in skin sensitivity. Pain was assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm horizontal line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Total scores range from 0 to 10, with higher scores indicating greater pain severity (worse outcome).
Day 1
Conditional Pain Modulation Assessment
大体时间:Day 1
A conditioning pressure stimulus will be applied to the non-dominant upper extremity, and the pressure pain threshold will be measured in the dominant upper extremity. The non-dominant hand will be immersed up to the wrist in a bucket of water at 37°C for 10 seconds to induce conditioning. The patient will then be asked to immerse their hand in water adjusted to 46°C for 30 seconds. This temperature has been used in many previous studies. During this time, the pressure pain threshold will be measured on the volar portion of the forearm of the contralateral extremity. Pain was assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm horizontal line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Total scores range from 0 to 10, with higher scores indicating greater pain severity (worse outcome).
Day 1

次要结果测量

结果测量
措施说明
大体时间
Quantitative Sensory Tests
大体时间:Day 1
Current evidence for determining pain phenotypes (Kosek et al.) recommends performing quantitative sensory testing. Quantitative sensory testing is divided into static tactile mechanical fixation threshold, hot-cold pain threshold, static mechanical allodynia, dynamic mechanical allodynia, and vibration assessment All assessments will be performed on the patient's non-dominant upper extremity.
Day 1
Muscle Oxygen Saturation Measurement
大体时间:Day 1
Oxygen saturation measurement will be performed using the MOXY (Fortiori Design LLC., Minnesota, USA) device. MOXY is a medical device measuring 61x44x21mm and weighing 42g. It is an infrared measuring device that measures oxygen saturation and total hemoglobin in muscle capillaries. It has self-adhesive light emitting and reflected light sensors placed a few centimeters apart on the skin. These devices penetrate the tissue a few centimeters using light and various algorithms to provide information about peripheral oxygen saturation in the microcirculation. It is a system that takes infrared measurements with 4 separate LED lights, penetrating to a depth of 12 mm to 25 mm, and provides the average numerically. It is a non-invasive method. In this study, muscle oxygen saturation will be measured over a three-minute period.
Day 1
The Body Awareness Questionnaire
大体时间:Day 1
The Body Awareness Questionnaire is a questionnaire consisting of 18 statements divided into four subgroups (Changes in body processes, sleep-wake cycle, prediction of disease onset, prediction of body responses) designed to determine the level of sensitivity to normal or abnormal body composition. Participants are asked to rate each statement on a scale of one to seven. The questionnaire uses a total score for the rating. A higher score indicates better body sensitivity.
Day 1
ABILHAND Rheumatoid Arthritis Hand Function Questionnaire
大体时间:Day 1
The ABILHAND-RA questionnaire focuses on functional items that best represent hand activities. Manual dexterity will be assessed using the ABILHAND-RA inventory, which consists of 27 common hand-use-based activities. Each activity will be scored as follows: 0 = impossible, 1 = difficult, 2 = easy. Volunteers will be asked to rate the ease with which they perform daily living activities, regardless of which limb is used or the method employed.
Day 1
Pain Catastrophizing Scale
大体时间:Day 1
The Pain Catastrophizing Scale was used to assess feelings and thoughts related to pain. This scale consists of 13 items. Each question is scored on a 5-point scale (0: Never, 1: Somewhat, 2: Moderately, 3: Severely, 4: Always). The scale consists of 3 sub-sections: helplessness, magnification, and rumination. The total score ranges from 0 to 52. Higher scores indicate higher pain catastrophizing.
Day 1
The International Physical Activity Questionnaire - Short Form
大体时间:Day 1
The International Physical Activity Questionnaire - Short Form assesses energy expenditure over the past week in total METs. It consists of seven questions. The total score is calculated by including the total duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous-intensity activity. For an activity to be included in the total score, each activity must have lasted at least 10 minutes. The questionnaire calculates a score in "MET-minutes/week (MET-min/week)" using the minutes spent during the activity, the number of days per week the activity was performed, and the MET value specified in the questionnaire.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月11日

初级完成 (估计的)

2027年11月11日

研究完成 (估计的)

2027年12月11日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2025年12月1日

更多信息

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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