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

NCT04570280 | Completed

• 1 other identifier: 2915
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Exercise; Exercise Therapy

Keywords

Rheumatoid Arthritis; Exercise Therapy; Exercise

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (3)

Range of Motion Exercises

PLACEBO COMPARATOR

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 and Resistive Exercises Group

ACTIVE COMPARATOR

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: Resistive Exercises; Other: Range of Motion Exercises

Range of Motion and Aerobic Exercises Group

ACTIVE COMPARATOR

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: Aerobic Exercises; Other: Range of Motion Exercises

Interventions

Resistive Exercises OTHER

Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.

Range of Motion and Resistive Exercises Group

Aerobic Exercises OTHER

Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.

Range of Motion and Aerobic Exercises Group

Range of Motion Exercises OTHER

Range of Motion Exercises will be applied 3 times a week for 12 weeks.

Range of Motion Exercises; Range of Motion and Aerobic Exercises Group; Range of Motion and Resistive Exercises Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37204935 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity

Interventions

Exercise; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 30, 2020
• Study Start: December 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 10, 2021
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)