Comparison of the Effects of Aerobic and Resistive Exercises in Female Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570280
• Other study ID #: 2915
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: December 2022
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 10, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Exercise
• Exercise Therapy
• Rheumatoid Arthritis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonographic Muscle Size Measurement	Ultrasonographic measurements of transverse muscle thickness will be made in M. Rectus femoris, vastus intermedius, long head of M. biceps femoris and medial head of M. Gastrocnemius. 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.	at 12th week
Primary	5 chair test	In the 5 chair test used in evaluating the functional status of the patient, "The practitioner allows the patient to sit on the chair with his back. The time it takes to sit and get up 5 times is measured with a stopwatch. " It will be made as.	at 12th week
Primary	Timed up and go test	In the timed get up and walk test, "3 meters of space is determined in front of the patient sitting on a chair. The patient is asked to get up from the chair, walk this distance and sit down again. Elapsed time is measured with a stopwatch. " It will be applied as.	at 12th week
Primary	6-minute walking test	In the 6-minute walking test, "The patient's goal should be to walk the longest distance that he can walk within 6 minutes. The longest distance that the patient can walk after 6 minutes is calculated in meters.	at 12th week
Primary	International Physical Activity Scale	Those who score HIGH on the IPAQ engage in; Vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET minutes a week OR; 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET minutes a week.; Scoring a MODERATE level of physical activity on the IPAQ means; 3 or more days of vigorous intensity activity and/or walking of at least 30 minutes per day OR; 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day OR; 5 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 600 MET minutes a week.; Scoring a LOW level of physical activity on the IPAQ means that you are not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.	at 12th week
Primary	Body Composition Measurements - Muscle	In body composition measurements measured with the DEXA device, total muscle (kg) and their ratio to the total body will be calculated.	at 12th week
Primary	Body Composition Measurements - Fat	In body composition measurements measured with the DEXA device, total fat mass according to regions (kg) and their ratio to the total body will be calculated.	at 12th week
Primary	Body Composition Measurements - Soft tissue	In body composition measurements measured with the DEXA device, total soft tissue mass (kg) and their ratio to the total body will be calculated.	at 12th week
Primary	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.	at 12th week
Primary	Visual Pain Scale	Visual pain scale scored from 0 (no pain) to 10 (maximal pain) will be used in the global pain assessment of the patient.	at 12th week
Primary	Fear assessment questionnaire in inflammatory rheumatic diseases	Fear assessment questionnaire in inflammatory rheumatic diseases will be filled. Minimum value is 0, maximum value is 100. Higher score is worse result	at 12th week
Primary	Body mass index	Body mass index (weight and height will be combined to report BMI in kg/m^2) will be calculated.	at 12th week