The Role of Isometric in Individuals With Rheumatoid Arthritis

NCT07665086 | Enrolling By Invitation

• 1 other identifier: Isometric Exercise
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Isometric Exercise; Pain; Oxygenation

Outcome Measures

Primary Outcomes (5)

• Pain Tolerance Assessment

  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

  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

• Temporal Summation Measurement

  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

• Conditional Pain Modulation Assessment

  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

• Visual Analog Scale (VAS) - Pain

  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

Secondary Outcomes (6)

• Quantitative Sensory Tests

  Day 1

• Muscle Oxygen Saturation Measurement

  Day 1

• The Body Awareness Questionnaire

  Day 1

• ABILHAND Rheumatoid Arthritis Hand Function Questionnaire

  Day 1

• Pain Catastrophizing Scale

  Day 1

Study Arms (2)

Control Group

NO INTERVENTION

Execise group

ACTIVE COMPARATOR

Other: Exercise

Interventions

Exercise OTHER

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.

Execise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zülal TATAR: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 11, 2027
• Last Updated: June 30, 2026

Record last verified: 2025-12

Locations

TU (1)