An interventional study of Exercise in Rheumatoid Arthritis, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care
The aim of this study is to investigate the effectiveness of the SARAH home exercise program to be applied for 12 weeks on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.
Finger/hand/wrist joints can be affected in the early period in patients with RA, and as the disease progresses, it can significantly limit the patient's functionality. Damage to articular and periarticular structures seen in inflammatory arthritis may affect the sense of proprioception by destroying mechanoreceptors located in these areas. Hand functions may worsen as a result of the worsening of the sense of proprioception, which can be defined as being aware of body parts.
SARAH (Strengthening and Stretching for Rheumatoid Arthritis of the Hand) home exercise program, which is a widely preferred approach in the case of hand involvement in patients with rheumatoid arthritis (RA), includes exercises to increase hand-wrist strength and mobility. Although the effectiveness of this program on pain, muscle strength, and range of motion has been demonstrated in large patient groups, its effect on proprioception and hand functions, which may be caused by inflammatory arthritis, has not been studied. Therefore, this study aims to investigate the effectiveness of the SARAH home exercise program on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.
2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 49 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
The SARAH exercise program will be delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) on a weekly basis.
Other: Exercise
Patients in the control group will not receive any exercise intervention. They will only maintain their routine medical treatment.
Participants will be asked to practice home exercises every day of the week for 12 weeks. The SARAH exercise program consists of 7 mobility and 4 strengthening exercises. Progress will be made by increasing the repetitions and duration of the exercises every week.
Change in Wrist Joint Position Sense
Wrist joint position sense will be evaluated with joint position sense goniometry. Joint position sense is measured by the ability to actively repeat a predetermined target angle. During the measurement, the wrist of the participant will passively be brought to the target angle and be kept in this position for three seconds. The participant will be asked to keep this position in his/her memory, then the wrist will passively be brought to the starting position. Then, the participant will be requested to bring her/his hand actively to these predetermined position. Wrist movements will be determined as three repetitive measurements for flexion, extension, radial deviation, and ulnar deviation directions.
Time frame: At baseline and twelve weeks later
Change in Hand Performance
Hand performance will be evaluated Nine-Hole Peg Test.
Time frame: At baseline and twelve weeks later
Change in Grip Strength
Hand grip strength will be evaluated with a hand-dynamometer.
Time frame: At baseline and twelve weeks later
Change in Pinch Strength
Pinch strength will be evaluated by using a pinchmeter.
Time frame: At baseline and twelve weeks later
Change in Self-reported Hand Functions
Duruoz Hand Index and The Measures of Activity Performance of the Hand Questionnaire will be used for subjective assessment of hand functions. Higher scores in both questionnaires reflect poorer hand functions.
Time frame: At baseline and twelve weeks later
Change in Pain
Numeric rating scale (NRS) will be used for pain assessment. NRS is scored between 0-10 and, higher scores indicate higher level of pain.
Time frame: At baseline and twelve weeks later
Change in Morning Stiffness
Morning stiffness related to the hand/wrist of the patients will be questioned by using Numeric Rating Scale (0-10) in terms of duration and severity. Higher scores indicate worse morning stiffness.
Time frame: At baseline and twelve weeks later
Change in Disease Activity
Disease Activity 28 C-Reactive Protein (DAS28-CRP) will be used to evaluate disease activity.
Time frame: At baseline and twelve weeks later
Change in General Functioning
Health Assessments Questionnaire-Disability Index, which is a self-report tool and has 20 items, will be used to evaluate the general functioning. All items are scored between 0 and 3. All scores are summed and divided by 20 to obtain a total score (0-3). Higher scores indicate a worse functional status.
Time frame: At baseline and twelve weeks later
Plan to share: Yes — Data will be available upon reasonable requests.
Time frame: Data will be available after completing the study and will be available for 20 years.
Access criteria: Data will be shared for only academic purposes (for conducting a meta-analysis or a systematic review)
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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