ClinicalTrials.gg
Enrolling by invitationNCT07665086Updated Jun 30, 2026

The Role of Isometric in Individuals With Rheumatoid Arthritis

An interventional study of Exercise in Isometric Exercise, Pain and Oxygenation, sponsored by Zülal TATAR. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Zülal TATAR · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2025, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,712 studies in Pain with a site in Turkey — 322 open to participants now, 372 under way, none of them phase 3. Pain · Turkey.

Planned enrollment
783rd of 1,489
66 · median 70
Started
2025
with 278 others
No phase
1,447 of 1,712
260 open now
Primary completion
2027-11
later than 366 of 371 live
Registered
1,606th of 1,712
by date

Among the 1,712 studies in Pain with a site in Turkey, this one is the 783rd largest by planned enrollment of the 1,489 interventional ones that give a count, is one of 279 that started in 2025, is one of 1,447 with no phase, reaches primary completion later than 366 of the 371 other live ones, and was the 1,606th registered.

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

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Open to participants now

322 of the 1,712 studies in Pain with a site in Turkey are open now. Recruiting first, the newest first:

317 more — sign in →

All 322 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Isometric Exercise
  • Pain
  • Oxygenation

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • No intervention
    Control Group
  • Active comparator
    Execise group

    Other: Exercise

Interventions

  • OtherExercise

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day 1

  2. 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).

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

  4. 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).

    Time frame: Day 1

  5. 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.

    Time frame: Day 1

Secondary outcomes

  1. Quantitative Sensory Tests

    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.

    Time frame: Day 1

  2. Muscle Oxygen Saturation Measurement

    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.

    Time frame: Day 1

  3. The Body Awareness Questionnaire

    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.

    Time frame: Day 1

  4. ABILHAND Rheumatoid Arthritis Hand Function Questionnaire

    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.

    Time frame: Day 1

  5. Pain Catastrophizing Scale

    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.

    Time frame: Day 1

  6. The International Physical Activity Questionnaire - Short Form

    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.

    Time frame: Day 1

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Nov 2027, 23 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 23 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 24, 2026
StartActual
Dec 11, 2025
Primary completionEst.
Nov 11, 2027
CompletionEst.
Dec 11, 2027
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07665086
Lead sponsor
Zülal TATAR
Responsible party
Zülal TATAR (Lecturer, Pamukkale University) — Sponsor-investigator
First posted
Jun 24, 2026
Start date
Dec 11, 2025
Primary completion
Nov 11, 2027 (estimated)
Completion
Dec 11, 2027 (estimated)
Last update
Jun 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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