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

Primary Purpose

Rheumatoid Arthritis, Exercise, Exercise Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercises
Resistive Exercises
Range of Motion Exercises
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Exercise Therapy, Exercise

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Range of Motion Exercises

Range of Motion and Resistive Exercises Group

Range of Motion and Aerobic Exercises Group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Body mass index
Body mass index (weight and height will be combined to report BMI in kg/m^2) will be calculated.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2020
Last Updated
December 14, 2022
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04570280
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Exercise, Exercise Therapy
Keywords
Rheumatoid Arthritis, Exercise Therapy, Exercise

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Range of Motion Exercises
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Range of Motion and Resistive Exercises Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Range of Motion and Aerobic Exercises Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercises
Intervention Description
Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Resistive Exercises
Intervention Description
Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Range of Motion Exercises
Intervention Description
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
Primary Outcome Measure Information:
Title
Ultrasonographic Muscle Size Measurement
Description
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.
Time Frame
at 12th week
Title
5 chair test
Description
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.
Time Frame
at 12th week
Title
Timed up and go test
Description
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.
Time Frame
at 12th week
Title
6-minute walking test
Description
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.
Time Frame
at 12th week
Title
International Physical Activity Scale
Description
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.
Time Frame
at 12th week
Title
Body Composition Measurements - Muscle
Description
In body composition measurements measured with the DEXA device, total muscle (kg) and their ratio to the total body will be calculated.
Time Frame
at 12th week
Title
Body Composition Measurements - Fat
Description
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.
Time Frame
at 12th week
Title
Body Composition Measurements - Soft tissue
Description
In body composition measurements measured with the DEXA device, total soft tissue mass (kg) and their ratio to the total body will be calculated.
Time Frame
at 12th week
Title
Short Form - 36
Description
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.
Time Frame
at 12th week
Title
Visual Pain Scale
Description
Visual pain scale scored from 0 (no pain) to 10 (maximal pain) will be used in the global pain assessment of the patient.
Time Frame
at 12th week
Title
Fear assessment questionnaire in inflammatory rheumatic diseases
Description
Fear assessment questionnaire in inflammatory rheumatic diseases will be filled. Minimum value is 0, maximum value is 100. Higher score is worse result
Time Frame
at 12th week
Title
Body mass index
Description
Body mass index (weight and height will be combined to report BMI in kg/m^2) will be calculated.
Time Frame
at 12th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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