- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263634
Hand Exercises in Psoriatic Arthritis
Investigation of the Effect of Hand Exercises on Grip Strength, Functionality, Disease Activity and Quality of Life in Patients With Psoriatic Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ishak Isik, MD
- Phone Number: +90 242 249 00 00
- Email: etik.kurul.07@gmail.com
Study Locations
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Antalya, Turkey
- Recruiting
- Akdeniz University
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Contact:
- Ayse Ayan, MD
- Phone Number: +90 242 249 44 00
- Email: drayseayan@yahoo.com.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with PsA by a physician according to CASPAR criteria
- Being 18 years or older
- Involvement in hand joints (pain, swelling, tenderness)
- Being on stable drug treatment for the last 6 months
- Having sufficient cooperation to participate in the study
- Volunteering to participate in the study
Exclusion Criteria:
- Having difficulty cooperating at work
- Having additional orthopedic and/or neurological disease that will affect hand functions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home exercises group
The intervention group will perform 30-45 minutes of home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week.
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30-45 minutes of home exercises consisting of stretching, mobility and strengthening
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No Intervention: Control group
Patients in the control group will be on the waiting list and will be taught hand exercises when the program ends.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psoriatic Arthritis Disease Activity Score (DAPSA)
Time Frame: 8 weeks
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DAPSA; It is a composite measurement focused on peripheral arthritis, developed for reactive arthritis, adapted to PsA patients and frequently used, evaluating disease activity and response to treatment in clinical studies.
There are four components of score including the parameters a) tender joint count (68 joints), b) swollen joint count (66 joints), c) CRP value (mg/l) and d) patient's disease activity and pain assessment (with a 10 cm visual analog scale).
DAPSA scores are calculated by summing each of these components.
Cut-off values for disease activity; A score of <4 was determined as remission, a score of <14 was determined as minimal disease activity, a score of <28 was determined as moderate disease activity, and a score of 28 was determined as high degree of disease activity.
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8 weeks
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Hand grip strength measurement
Time Frame: 8 weeks
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Hand grip strength will be measured with a Jamar hydraulic hand dynamometer (Sammons Preston, USA).
Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists.
This is the standard position; The patient is seated in a position that provides 90-20 degree flexion of the hip and knee, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation.
The measurement will be repeated three times.
There will be a 15-second rest break at the end of each measurement.
As a result, the average of three measurements will be recorded.
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8 weeks
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Hand fine grip strength measurement:
Time Frame: 8 weeks
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Fine grip strength measurements will be made with finger dynamometry (Pinchmeter-Sammons Preston, USA). Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient is seated in a position that provides 90 degrees of hip and knee flexion, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. Three different finger grips will be evaluated. These: 1- Fingertip grip strength, 2- Lateral grip strength, 3- Three point grip strength. Measurements will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded. |
8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nine-Hole Peg Test
Time Frame: 8 weeks
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This is a device consisting of a square platform and a storage box.
There are 9 holes in the square-shaped area and 9 cylinders suitable for these holes.
The patient is asked to quickly take the 9 cylinders from the storage box, place them in the holes in random order, and quickly remove them from the holes without taking a break and place them in the storage box.
Meanwhile, time is measured in seconds with a stopwatch.
The test is performed 2 times consecutively for both hands and the average of the result is taken.
The total test score is calculated by averaging the scores for both hands.
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8 weeks
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Duruöz Hand Index
Time Frame: 8 weeks
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It is a valuable test that was first developed in 1996 to evaluate the hand functions of patients with Rheumatoid Arthritis and whose validity and reliability have been proven in many diseases related to the upper extremity.
The test consists of 18 questions.
It is a simple, useful and reliable test that is presented by separating daily life functions (kitchen, clothing, cleaning, workplace and other daily life activities), does not require additional training and equipment for the test, and takes approximately 2-3 minutes to apply.
It is a simple and understandable test in which questions are answered according to a Likert scale, with a minimum score of 0 and a maximum of 90 points.
A lower score indicates a better functional state.
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8 weeks
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Michigan Hand Outcome Questionnaire (MHQ)
Time Frame: 8 weeks
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This questionnaire is a scale consisting of six sections and 57 different items.
It helps us question how well patients perform tasks they frequently perform.
The patient answers the questions according to the Likert measurement method, which gives values from one to five.
While each section receives a score between zero and one hundred, zero represents the worst score and one hundred represents the best score in each section, except for pain.
A higher score in the pain section indicates more pain.
The first part measures the average function of the patient's right and left hands.
The second part contains questions examining daily living activities for both hands.
In the third section, activities performed with both hands are questioned.
The fourth part aims to question pain for both hands.
In the fifth part, both hands are questioned aesthetically, and in the sixth part, the extent to which both hands satisfy the patient is questioned.
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8 weeks
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Hand Functional Index (HFI)
Time Frame: 8 weeks
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The validity and reliability of the Hand Functional Index (the first 9 questions of the Keitel Functional Index) were conducted by Mehmet Tuncay Duruöz in 1998 in patients with Rheumatoid Arthritis.
The test consists of 9 questions.
Each question has a different score.
The highest total score an individual can get in the test is 21 points, and the lowest total score is 2. As the total score decreases, the functionality of the individual's hand increases.
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8 weeks
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Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL)
Time Frame: 8 weeks
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It is used to evaluate the effects of PsA on individuals' quality of life.
If there is a change in PsAQoL scores after treatment, it means that the applied treatment has an impact on the quality of life.
This scale consists of 20 questions and is a practical, easily and quickly applicable survey with yes/no answers.
Scoring is made as "yes: 1", "no: 0".
A high score indicates a low quality of life.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebahat Yaprak Cetin, PhD, Akdeniz University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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