Comparison of the Effects of Aerobic and Resistive Exercises in Female Patients With Rheumatoid Arthritis
NCT ID: NCT04570280
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2020-12-01
2021-10-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the patient completes the 12-week exercise program, ultrasonographic measurements of transverse muscle thickness of M. Rectus femoris, vastus intermedius, long head of M.Biceps femoris and medial head of M. , 6-minute walk test, body composition measurements with DEXA device and quality of life measurements with SF-36, fatigue severity scale, fear assessment questionnaire in inflammatory rheumatic diseases and scales for other rheumatoid arthritis and pain status. Ultrasonographic measurements will be made at the midpoint between the anterior superior iliac spina and the upper end of the patella for rectus femoris and vastus intermedialis. For the medial head of the gascrokinemius, the measurement will be made at the thickest point where the head of the muscle is in the leg area, and for the biceps femoris muscle, 60% distal between the greater trochanter and the outer femoral condyle, and at the intersection point of a line drawn at the midline of the popliteal fossa. While measurements made for rectus femoris and vastus intermedius were evaluated in the supine position; The biceps femoris and gastrocnemius will be evaluated while the patient lies comfortably in the prone position.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Range of Motion Exercises
The patients in the control group will be given the practice of range of motion exercises for 12 weeks, 3 days a week for 50 minutes (1 day accompanied by a physiotherapist).
Range of Motion Exercises
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Range of Motion and Resistive Exercises Group
Patients in this group will be given joint range of motion and resistive exercises with sandbag to the lower extremity for 12 weeks, 3 days a week for 50 minutes (1 day in the presence of a physiotherapist). For the exercises with resistance, the repetition maximum will be calculated and the intensity of the exercises will be adjusted in accordance with the DeLorme protocol.
Resistive Exercises
Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
Range of Motion Exercises
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Range of Motion and Aerobic Exercises Group
Joint range of motion exercises and aerobic exercises on the treadmill will be given to the aerobic exercise arm, 3 days a week for 12 weeks (1 day in the presence of a physiotherapist). For aerobic exercises, the maximum heart rate of the patients will be calculated during exercise and the exercise intensity will be determined by increasing the target heart rate level during the exercise.
Aerobic Exercises
Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.
Range of Motion Exercises
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aerobic Exercises
Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.
Resistive Exercises
Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
Range of Motion Exercises
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female gender
* The patient has been in remission or low disease activity for at least 3 months
* 20-50 years
Exclusion Criteria
* Significant deformity and inability to ambulate in the lower extremity joints
* Pregnant patient
* Patient with menopause
* The presence of malignancy
* A patient with a serious psychiatric disorder and difficulty in cooperation
* Presence of cardiovascular and pulmonary comorbidity that may prevent exercise
* Male gender
20 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aylin Ayyıldız
Medical Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ayyildiz A, Yilmaz F, Altindas H, Ciftci S, Kuran B. Effects of Aerobic and Resistive Exercise on Muscle Measurements and Body Composition in Female Patients With Rheumatoid Arthritis. Am J Phys Med Rehabil. 2023 Dec 1;102(12):1076-1084. doi: 10.1097/PHM.0000000000002283. Epub 2023 May 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2915
Identifier Type: -
Identifier Source: org_study_id