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- Essai clinique NCT07665086
The Role of Isometric in Individuals With Rheumatoid Arthritis
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Denizli, Turquie (Türkiye)
- Pamukkale University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Groupe de contrôle
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Temporal Summation Measurement
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quantitative Sensory Tests
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 décembre 2025
Achèvement primaire (Estimé)
11 novembre 2027
Achèvement de l'étude (Estimé)
11 décembre 2027
Dates d'inscription aux études
Première soumission
18 juin 2026
Première soumission répondant aux critères de contrôle qualité
18 juin 2026
Première publication (Réel)
24 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 décembre 2025
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Isometric Exercise
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .