Clinical trial NCT04570280: Comparison of the Effects of Aerobic and Resistive Exercises in Female Patients With Rheumatoid Arthritis
Official title: Comparison of the Effects of Aerobic and Resistive Exercises on Sonographic Muscle Measurements, Functional Status, Body Composition and Quality of Life in Female Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Exercise
Exercise Therapy
Keywords: Rheumatoid Arthritis
Exercise Therapy
Exercise
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: It is aimed to objectively demonstrate and compare the effectiveness of aerobic and resistant exercises performed on female patients with rheumatoid arthritis with sonographic muscle measurements. In addition, it is planned to compare the effects of 2 group exercises on functional status, quality of life and body composition and to show its correlation with sonographic measurements. There are 3 groups in total in the study. These are the control group given only the range of motion exercise, the second group given the range of motion and resistance exercise, and the third group given the range of motion and aerobic exercise. Exercise programs will last 12 weeks and it is planned to exercise 3 days a week.

Detailed description: There are 3 groups in total in the study. The patients in the control arm will be given the practice of range of motion exercises for 50 minutes (1 day with a physiotherapist) 3 days a week for 12 weeks. The resistance exercise group will be given range of motion and resistance exercises with sandbag to the lower extremities for 12 weeks, 3 days a week for 50 minutes (1 day in the presence of a physiotherapist). In the aerobic exercise group, range of motion exercises and aerobic exercises on the treadmill will be given 50 minutes (1 day in the presence of a physiotherapist) 3 days a week for 12 weeks.

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.

Eligibility criteria: Inclusion Criteria:

* Romatoid Arthritis diagnosed for\> 1 year
* Female gender
* The patient has been in remission or low disease activity for at least 3 months
* 20-50 years

Exclusion Criteria:

* Patient with active arthritis or high disease activity
* 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

Primary outcomes:
measure: Ultrasonographic Muscle Size Measurement
timeFrame: at 12th week
measure: 5 chair test
timeFrame: at 12th week
measure: Timed up and go test
timeFrame: at 12th week
measure: 6-minute walking test
timeFrame: at 12th week
measure: International Physical Activity Scale
timeFrame: at 12th week
measure: Body Composition Measurements - Muscle
timeFrame: at 12th week
measure: Body Composition Measurements - Fat
timeFrame: at 12th week
measure: Body Composition Measurements - Soft tissue
timeFrame: at 12th week
measure: Short Form - 36
timeFrame: at 12th week
measure: Visual Pain Scale
timeFrame: at 12th week
measure: Fear assessment questionnaire in inflammatory rheumatic diseases
timeFrame: at 12th week
measure: Body mass index
timeFrame: at 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
References: