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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Exercise; Exercise Therapy
• Intervention / Treatment: Other: Range of Motion Exercises; Other: Resistive Exercises; Other: Aerobic Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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).	Other: Range of Motion Exercises; Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Active Comparator: 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.	Other: Range of Motion Exercises; Range of Motion Exercises will be applied 3 times a week for 12 weeks.; Other: Resistive Exercises; Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
Active Comparator: 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.	Other: Range of Motion Exercises; Range of Motion Exercises will be applied 3 times a week for 12 weeks.; Other: Aerobic Exercises; Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 10, 2021

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Rheumatoid Arthritis; Exercise Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No