The Effect of Exercise Training on lncRNA Expression in Rheumatoid Arthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard pulmonary rehabilitation programme: Patients are asked to perform thoracic, diaphragmatic breathing, and lower basal breathing exercises with 10 repetitions. Then, strengthening exercises are performed on the major muscle groups of the upper and lower extremities. In accordance with the resistance training program in the ATS/ERS guidelines for pulmonary rehabilitation, two to four sets of 6-12 repetitions are performed with intensities ranging from 50% to 85% of one maximum repetition, two to three times a week. During the exercises, the patient is questioned about their fatigue and dyspnea levels using the Borg scale, and breaks are given when necessary. The aerobic exercise program is performed as a 12-week, 3-day-a-week self-walking exercise. The walking program is performed in the form of walking on flat ground at 60% workload, based on the data obtained from the 6-minute walking test result (land-based walking).

Resistive threshold inspiratory muscle training: In the other arm of the study, respiratory muscle training is performed in addition to the "standard pulmonary rehabilitation program." Respiratory muscle strengthening training is performed with a resistive thereshold inspiratory muscle strengthening device. The exercise is performed at an intensity of 30% of the maximum inspiratory pressure determined by mouth pressure measurement. The exercise is performed in 7 sets, with 2 minutes of work and 1 minute break for a total of 21 minutes.

No intervention: Peripheral blood samples will be taken once from the participants in the control group and no other intervention will be performed.

Study summary

The goal of this observational study is to examine the effects of traditional respiratory rehabilitation and respiratory muscle strengthening training added to this program at the genetic level in in patients with rheumatoid arthritis-associated interstitial lung disease. The main questions it aims to answer are:

* Does respiratory muscle strengthening exercise added to respiratory rehabilitation in patients with rheumatoid arthritis-associated interstitial lung disease have additional benefits on rehabilitation outcome measures such as exercise capacity, shortness of breath, and muscle strength?
* Does the gain obtained with respiratory muscle strengthening iin patients with rheumatoid arthritis-associated interstitial lung disease increase the quality of life of patients and have a positive effect on their psychological state?
* Does respiratory rehabilitation applied to iin patients with rheumatoid arthritis-associated interstitial lung disease have an effect on genetic changes?
* Does respiratory muscle strengthening training applied in addition to respiratory rehabilitation in patients with rheumatoid arthritis-associated interstitial lung disease have an effect on genetic changes?
* Participants will be included in two different respiratory rehabilitation programs with and without respiratory muscle training, and pre- and post- treatment rehabilitation criteria and genetic changes will be compared.

Eligibility

Primary outcome measure(s)

• lncRNA HOTAIR expression levels — Baseline and 12 weeks
  Peripheral blood mononuclear cells (PBMCs) will be isolated from venous blood samples collected at baseline and at Week 12. Total RNA will be extracted from PBMCs and reverse-transcribed into complementary DNA (cDNA). lncRNA HOTAIR expression will be quantified using real-time quantitative polymerase chain reaction (RT-qPCR). Each sample will be analyzed in duplicate. Cycle threshold (Ct) values will be normalized to a reference housekeeping gene to calculate ΔCt values. Changes in HOTAIR expression between baseline and Week 12 will be determined using the ΔΔCt method and expressed as fold change (2-ΔΔCt).
• Short Form - 36 — Baseline and 12 weeks
  In the evaluation with the short form-36, it is aimed to learn the patient's views about her own health, how she feels and how much she can perform her daily activities. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
• Respiratory Muscle Strength Measurement — Baseline and 12 weeks
  The patient is seated in a straight-backed chair. The patient is asked to grasp the silicone mouthpiece with his/her mouth and inhale and exhale as quickly and deeply as possible. The measurements are repeated until 3 measurement values are obtained with a maximum of 10% deviation between the measured peak value. The maximum value is taken among the measured values.
• Visual Analog Scale (VAS) — Baseline and 12 weeks
  Pain level will be assessed using with Visual Analog Scale. VAS is a scale which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). A higher score indicates greater pain intensity.
• Exercise capacity (6-minute walk test) — Baseline and 12 weeks
  6-minute walk test is performed for exercise capacity. After resting in a chair for a sufficient period (\>30 minutes), patients walk as fast as possible, without running, for 6 minutes on a straight 30-meter corridor. Before and after the test, the patient's fatigue and dyspnea are questioned using the Modified Borg Scale. Oxygen saturation and heart rate are monitored and recorded using a finger pulse oximeter before, during, and after the test.

Trial sites (1)

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