Psoriatic ArthritisNCT06263634
Hand Exercises in Psoriatic Arthritis
A study testing Hand exercises in people with Psoriatic Arthritis and Hand Rheumatism, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis, Hand Rheumatism
- What is being tested?
- Hand exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2023to 5 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having difficulty cooperating at work
- Having additional orthopedic and/or neurological disease that will affect hand functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Hand Exercises on Grip Strength, Functionality, Disease Activity and Quality of Life in Patients With Psoriatic Arthritis
This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform 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. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease that is in the spondyloarthritis group and is frequently accompanied by peripheral arthritis, dactylitis, enthesitis, spondylitis and accompanied by psoriasis. Although hand effects in patients with PsA are known, there is no exercise study performed only on the hand and no study examining the effect of this study on the grip strength and functionality of the hand. This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. 34 individuals with PsA who meet the inclusion criteria will be included in the study. Individuals participating in the study will be randomly divided into 2 groups. Individuals in 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. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. Evaluations will be made twice, at the beginning and at the end of the 8-week program. In the evaluation, the demographic form, Psoriatic Arthritis Disease Activity Score (DAPSA), Grip Strength, Nine-Hole Peg Test, Duruöz Hand Index, Michigan Hand Outcome Questionnaire (MHQ) Functional Hand Index, Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) will be applied. This study will be one of the first studies to show the effects of hand exercises on PsA disease activity, grip strength, functionality and quality of life.
- Conditions
- Psoriatic Arthritis, Hand Rheumatism
- Being tested
- Hand exercises
- Keywords
- Psoriatic Arthritis, hand exercises, grip strength, functionality, disease activity, quality of life
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand exercisesOther
30-45 minutes of home exercises consisting of stretching, mobility and strengthening
| Study group | Role | What they receive |
|---|---|---|
| Home exercises group | Experimental | 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. Receives: Other: Hand exercises |
| Control group | No intervention | Patients in the control group will be on the waiting list and will be taught hand exercises when the program ends. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriatic Arthritis Disease Activity Score (DAPSA)
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.
Measured: 8 weeks
Hand grip strength measurement
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.
Measured: 8 weeks
Hand fine grip strength measurement:
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.
Measured: 8 weeks
Secondary outcomes (5)
Nine-Hole Peg Test
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.
Measured: 8 weeks
Duruöz Hand Index
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.
Measured: 8 weeks
Michigan Hand Outcome Questionnaire (MHQ)
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.
Measured: 8 weeks
Hand Functional Index (HFI)
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.
Measured: 8 weeks
Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start5 Apr 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
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 Psoriatic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin, PT, Akdeniz University
- Investigators
- Sebahat Yaprak Cetin, PhD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263634
- Sponsor's protocol ID
- 2022-206
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plans, data and analysis will share with SPSS program with other researchers
Publications
Candiri B, Talu B, Demirtas Karaoba D, Ozaltin GE, Yolbas S. Effect of psoriatic arthritis on the strength, proprioception, skill, coordination, and functional condition of the hand. Int J Rheum Dis. 2022 Jan;25(1):47-55. doi: 10.1111/1756-185X.14241. Epub 2021 Nov 24.
PubMed 34821039
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Hand Exercises on Grip Strength, Functionality, Disease Activity and Quality of Life in Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06263634
- Acronym / sponsor ID
- 2022-206
- Conditions
- Psoriatic Arthritis, Hand Rheumatism
- Keywords
- Psoriatic Arthritis, hand exercises, grip strength, functionality, disease activity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 16 Feb 2024 (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.
This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform 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. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease that is in the spondyloarthritis group and is frequently accompanied by peripheral arthritis, dactylitis, enthesitis, spondylitis and accompanied by psoriasis. Although hand effects in patients with PsA are known, there is no exercise study performed only on the hand and no study examining the effect of this study on the grip strength and functionality of the hand. This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. 34 individuals with PsA who meet the inclusion criteria will be included in the study. Individuals participating in the study will be randomly divided into 2 groups. Individuals in 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. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. Evaluations will be made twice, at the beginning and at the end of the 8-week program. In the evaluation, the demographic form, Psoriatic Arthritis Disease Activity Score (DAPSA), Grip Strength, Nine-Hole Peg Test, Duruöz Hand Index, Michigan Hand Outcome Questionnaire (MHQ) Functional Hand Index, Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) will be applied. This study will be one of the first studies to show the effects of hand exercises on PsA disease activity, grip strength, functionality and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Home exercises group | Experimental | Other: Hand exercisesThe 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. |
| Control group | No intervention | –Patients in the control group will be on the waiting list and will be taught hand exercises when the program ends. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Having difficulty cooperating at work
- Having additional orthopedic and/or neurological disease that will affect hand functions
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 |
|---|---|---|
| Hand exercises30-45 minutes of home exercises consisting of stretching, mobility and strengthening | Other | Home exercises group |
Primary outcome
Psoriatic Arthritis Disease Activity Score (DAPSA)
Time frame: 8 weeks
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.
Hand grip strength measurement
Time frame: 8 weeks
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.
Hand fine grip strength measurement:
Time frame: 8 weeks
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.
5 secondary outcomes
Nine-Hole Peg Test
Time frame: 8 weeks
Duruöz Hand Index
Time frame: 8 weeks
Michigan Hand Outcome Questionnaire (MHQ)
Time frame: 8 weeks
Hand Functional Index (HFI)
Time frame: 8 weeks
Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL)
Time frame: 8 weeks
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 10 Jun 2024.
- Results publication: PubMed 34821039Candiri B, Talu B, Demirtas Karaoba D, Ozaltin GE, Yolbas S. Effect of psoriatic arthritis on the strength, proprioception, skill, coordination, and functional condition of the hand. Int J Rheum Dis. 2022 Jan;25(1):47-55. doi: 10.1111/1756-185X.14241. Epub 2021 Nov 24.
- full textLink provided by the sponsor.
- Individual participant dataSharing planned: No. Plans, data and analysis will share with SPSS program with other researchers
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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.
Sebahat Yaprak Cetin, PhD principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand exercises in people with Psoriatic Arthritis and Hand Rheumatism, run by Akdeniz University 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 6 inclusion and 2 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 10 Jun 2024. 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. 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?
Psoriatic Arthritis Disease Activity Score (DAPSA) (time frame: 8 weeks). The study lists 3 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 NCT06263634, 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 10 Jun 2024.