NCT06263634

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

June 10, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 9, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

Psoriatic Arthritishand exercisesgrip strengthfunctionalitydisease activityquality of life

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    8 weeks

Secondary Outcomes (5)

  • Nine-Hole Peg Test

    8 weeks

  • Duruöz Hand Index

    8 weeks

  • Michigan Hand Outcome Questionnaire (MHQ)

    8 weeks

  • Hand Functional Index (HFI)

    8 weeks

  • Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL)

    8 weeks

Study Arms (2)

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.

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.

Interventions

30-45 minutes of home exercises consisting of stretching, mobility and strengthening

Home exercises group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having difficulty cooperating at work
  • Having additional orthopedic and/or neurological disease that will affect hand functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sebahat Yaprak Cetin, PhD

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 16, 2024

Study Start

April 5, 2023

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

June 10, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Plans, data and analysis will share with SPSS program with other researchers

Locations