Rheumatoid ArthritisNCT04570280
Comparison of the Effects of Aerobic and Resistive Exercises in Female Patients With Rheumatoid Arthritis
A study testing Aerobic Exercises, Resistive Exercises and Range of Motion Exercises in people with Rheumatoid Arthritis and Exercise, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Exercise, Exercise Therapy
- What is being tested?
- Aerobic Exercises, Resistive Exercises and Range of Motion Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Exercise, Exercise Therapy
- Being tested
- Aerobic Exercises, Resistive Exercises, Range of Motion Exercises
- Keywords
- Rheumatoid Arthritis, Exercise Therapy, Exercise
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExercisesOther
Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.
Resistive ExercisesOther
Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
Range of Motion ExercisesOther
Range of Motion Exercises will be applied 3 times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: Aerobic Exercises; Other: Range of Motion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: at 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Dec 2020
- Primary completion30 Sep 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570280
- Sponsor's protocol ID
- 2915
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37204935
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04570280
- Acronym / sponsor ID
- 2915
- Conditions
- Rheumatoid Arthritis, Exercise, Exercise Therapy
- Keywords
- Rheumatoid Arthritis, Exercise Therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Range of Motion Exercises | Placebo comparator | Other: Range of Motion ExercisesThe 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). |
| Range of Motion and Resistive Exercises Group | Active comparator | Other: Resistive Exercises, Other: Range of Motion ExercisesPatients 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. |
| Range of Motion and Aerobic Exercises Group | Active comparator | Other: Aerobic Exercises, Other: Range of Motion ExercisesJoint 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExercisesAerobic exercises with treadmill will be applied 3 times a week for 12 weeks. | Other | Range of Motion and Aerobic Exercises Group |
| Resistive ExercisesResistive exercises with sandbag will be applied 3 times a week for 12 weeks. | Other | Range of Motion and Resistive Exercises Group |
| Range of Motion ExercisesRange of Motion Exercises will be applied 3 times a week for 12 weeks. | Other | Range of Motion Exercises, Range of Motion and Aerobic Exercises Group, Range of Motion and Resistive Exercises Group |
Primary outcome
Ultrasonographic Muscle Size Measurement
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
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
Time frame: at 12th week
Body mass index (weight and height will be combined to report BMI in kg/m^2) will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 37204935Ayyildiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercises, Resistive Exercises and Range of Motion Exercises in people with Rheumatoid Arthritis and Exercise, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Muscle Size Measurement (time frame: at 12th week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.