The Effect of Exercise Training on lncRNA Expression in Rheumatoid Arthritis

NCT07320846 | Recruiting

• 2 other identifiers: Rheumatoid_HOTAIR2024-93
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise; Pulmonary Rehabilitation; Interstitial Lung Disease; Long Noncoding RNA; Inspiratory Muscle Training; Rheumatoid Arthritis

Keywords

inspiratory muscle training; long noncoding RNA; exercise; pulmonary rehabilitation; Interstitial lung disease; rheumatoid arthritis

Outcome Measures

Primary Outcomes (5)

• lncRNA HOTAIR expression levels

  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).

  Baseline and 12 weeks

• Short Form - 36

  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.

  Baseline and 12 weeks

• Respiratory Muscle Strength Measurement

  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.

  Baseline and 12 weeks

• Visual Analog Scale (VAS)

  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.

  Baseline and 12 weeks

• Exercise capacity (6-minute walk test)

  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.

  Baseline and 12 weeks

Secondary Outcomes (8)

• Modified Medical Research Council (mMRC) Dyspnea Scale

  Baseline and 12 weeks

• HAQ

  Baseline and 12 weeks

• Forced Expiratory Volume in 1 Second (FEV₁)

  Baseline and 12 weeks

• Forced Vital Capacity (FVC)

  Baseline and 12 weeks

• Quality of life level

  Baseline and 12 weeks

Study Arms (3)

Standart Pulmonary Rehabilitation Group (SGr)

ACTIVE COMPARATOR

In the SGr program, exercises are planned to be performed under the supervision of a remote physiotherapist, 2 days a week with the telerehabilitation method and 1 day as a home- based program by the patient. The exercise program includes aerobic, resistance exercises and respiratory exercises, and patients are followed for 3 months.

Behavioral: Standard pulmonary rehabilitation programme

Pulmonary Rehabilitation Group with Inspiratory Muscle Training (IGr)

EXPERIMENTAL

In the IGr program, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method 2 days a week and with a program to be done by the patient at home 1 day a week. The exercise program includes aerobics, resistance exercises, respiratory exercises and respiratory muscle strengthening training with a resistive thereshold inspiratory muscle strengthening device, and patients are followed for 3 months.

Control Group (CGr)

OTHER

The KGr group will consist of women and men aged between 18-75, who have signed the informed consent form regarding the study, have a BMI \<30, are non-smokers, have no known systemic disease, and have FEV1\>80, and are age and gender matched to the exercise groups.

Other: No intervention

Interventions

Standard pulmonary rehabilitation programme BEHAVIORAL

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).

Standart Pulmonary Rehabilitation Group (SGr)

Resistive threshold inspiratory muscle training DEVICE

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 OTHER

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

Control Group (CGr)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with RA according to the ACR/EULAR 2010 classification criteria
• Duration of diagnosis greater than 2 years
• Disease activity with a DAS28 score below 5.1
• Voluntary participation in the study
• Presence of lung involvement

You may not qualify if:

• Having orthopedic deformities that may affect the treatment program
• Pregnancy
• Uncontrolled diabetes or heart disease
• Participation in a rehabilitation program within the last 6 months
• Body Mass Index (BMI) \> 30
• Patients with severe organ failure
• Recent acute coronary syndrome
• Presence of active infection

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Turkey, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity; Lung Diseases, Interstitial; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Behavior; Lung Diseases; Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Esra PEHLİVAN, Assoc. Prof.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Erdoğan ÇETİNKAYA, Prof. Dr.

  Yedikule Chest Diseases And Thoracic Surgery Training And Research Hospital

  STUDY DIRECTOR

• Zeynep Betül ÖZCAN, PhD (c)

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Betül ÖZCAN

CONTACT

+90 216 346 36 36; zbetulozcan@gmail.com

Esra PEHLİVAN

CONTACT

+90 216 346 36 36; esra.pehlivan@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Assignment

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 6, 2026
• Study Start: May 18, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 12, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)