- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07665086
The Role of Isometric in Individuals With Rheumatoid Arthritis
26. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zápis na pozvánku
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
66
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Denizli, Turecko (Türkiye)
- Pamukkale University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Kontrolní skupina
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Aktivní komparátor: Execise group
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Temporal Summation Measurement
Časové okno: Day 1
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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.
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Day 1
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Visual Analog Scale (VAS) - Pain
Časové okno: Day 1
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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.
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Day 1
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Pain Tolerance Assessment
Časové okno: Day 1
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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).
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Day 1
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Pressure Pain Threshold Assessment
Časové okno: Day 1
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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).
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Day 1
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Conditional Pain Modulation Assessment
Časové okno: Day 1
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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).
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Day 1
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Quantitative Sensory Tests
Časové okno: Day 1
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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.
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Day 1
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Muscle Oxygen Saturation Measurement
Časové okno: Day 1
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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.
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Day 1
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The Body Awareness Questionnaire
Časové okno: Day 1
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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.
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Day 1
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ABILHAND Rheumatoid Arthritis Hand Function Questionnaire
Časové okno: Day 1
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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.
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Day 1
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Pain Catastrophizing Scale
Časové okno: Day 1
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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.
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Day 1
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The International Physical Activity Questionnaire - Short Form
Časové okno: Day 1
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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.
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Day 1
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. prosince 2025
Primární dokončení (Odhadovaný)
11. listopadu 2027
Dokončení studie (Odhadovaný)
11. prosince 2027
Termíny zápisu do studia
První předloženo
18. června 2026
První předloženo, které splnilo kritéria kontroly kvality
18. června 2026
První zveřejněno (Aktuální)
24. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. června 2026
Naposledy ověřeno
1. prosince 2025
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Isometric Exercise
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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