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The Role of Isometric in Individuals With Rheumatoid Arthritis

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Gruppo di controllo
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Temporal Summation Measurement
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quantitative Sensory Tests
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 dicembre 2025

Completamento primario (Stimato)

11 novembre 2027

Completamento dello studio (Stimato)

11 dicembre 2027

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Isometric Exercise

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .