NCT07072754

Brief Summary

This study aims to elucidate the potential benefits of exercise for individuals with rheumatoid arthritis. The findings are expected to contribute to the development of novel and effective therapeutic approaches, ultimately leading to an improved quality of life for patients. For both patients and healthcare professionals, a clearer understanding of exercise's role in rheumatoid arthritis management will serve as a crucial guide in formulating individualized treatment plans. The results of our study will provide valuable insights to aid in developing strategies aimed at enhancing the physical and mental well-being of individuals afflicted with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

July 9, 2025

Last Update Submit

July 9, 2025

Conditions

Keywords

rheumatoid arthritisyogacombined exercisepain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    The Visual Analogue Scale (VAS) was used for pain intensity assessment in all patients. The scale is a 10-cm line, with the leftmost part showing no pain and the rightmost part showing maximum pain. Patients were asked to point to the proper place on the line according to the pain they experienced last week. An increase of 20% or above indicates clinical significance in VAS.

    From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline

Secondary Outcomes (5)

  • Balance Index

    From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline

  • Mobility Level

    From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline

  • Depression Level

    From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline

  • Fatigue Level

    From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline

  • Quality of Life Level

    From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline

Study Arms (3)

Yoga

EXPERIMENTAL

The yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. It was applied for a total of 8 weeks.

Other: Mind-body therapy

Combined Exercise

EXPERIMENTAL

Patients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks.

Other: Exercise

Control

NO INTERVENTION

No exercise was applied to the subjects included in the control group.

Interventions

The yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. Foam yoga blocks, belts, and armless chairs were also available in the classes, where the participants were to support compliance with the program. The yoga program was planned as 10 minutes of centering and breathing practice, 10 minutes of warm-up practice, 30 minutes of supine, standing, sitting, prone, and supine yoga postures, and 10 minutes of relaxation. New postures were introduced every two weeks as the program progressed. After the eight-week session, the participants were encouraged to continue the program at home twice a week

Also known as: Yoga
Yoga

Patients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks. Aerobic exercise was performed by standing still for 25 minutes at moderate intensity based on perceived effort. Strengthening exercises included one set of 10 repetitions for each movement. Exercises were progressed according to the modified Borg's scale. Strengthening exercises included core muscles such as the deltoid, abdominals, quadriceps femoris, and hamstrings and were performed using body weight or elastic resistance bands

Combined Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of RA for at least six months according to the ACR criteria
  • aged between 18-65 years,
  • under stabil medications at least four weeks
  • the disease activity score 28 (DAS 28) \<2.6 (Remission period) of each patient at least three months
  • ability to provide written informed consent.

You may not qualify if:

  • had pain that prevents general mobility,
  • had neurologic, cardiologic (arrhythmias, myocardial infarction, uncontrolled metabolic disease,
  • known electrolyte abnormalities,
  • systolic BP \> 200 mm Hg or diastolic BP \> 115 mm Hg)
  • respiratory pathology,
  • pregnancy
  • had malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katip Celebi University Atatürk Education and Research Hospital

Izmir, Karabaglar, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Interventions

Mind-Body TherapiesYogaExercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif Umay Altas, Associate Professor Doctor

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

February 1, 2018

Primary Completion

March 1, 2019

Study Completion

May 1, 2023

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Personal data will not be shared. All data will be shared blindly by special request, provided that a valid reason is given.

Locations