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SARAH Exercise Program in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Hand, Proprioception, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: RA diagnosis according to 2010 ACR/EULAR RA criteria Being between the ages of 18-65 Being able to follow Turkish instructions Volunteering to participate in the study Exclusion Criteria: Being in an acute disease exacerbation period Ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months History of steroid injection, surgery, or trauma to the upper extremity in the last 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Group

    Control Group

    Arm Description

    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.

    Patients in the control group will not receive any exercise intervention. They will only maintain their routine medical treatment.

    Outcomes

    Primary Outcome Measures

    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.
    Change in Hand Performance
    Hand performance will be evaluated Nine-Hole Peg Test.
    Change in Grip Strength
    Hand grip strength will be evaluated with a hand-dynamometer.
    Change in Pinch Strength
    Pinch strength will be evaluated by using a pinchmeter.
    Change in Self-reported Hand Functions
    Duruoz Hand Index and The Measures of Activity Performance of the Hand (MAP-Hand) Questionnaire will be used for subjective assessment of hand functions.

    Secondary Outcome Measures

    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.
    Change in Morning Stiffnes
    Morning stiffness related to the hand/wrist of the patients will be questioned in terms of duration and severity.
    Change in Disease Activity
    Disease Activity 28 C-Reactive Proten (DAS28-CRP) will be used to evaluate disease activity.
    Change in General Functioning
    Health Assesments Questionnaire-Disability Index (HAQ-DI), which is a self-report tool and has 20 items, will be used to evaluate the general functioning.

    Full Information

    First Posted
    January 27, 2023
    Last Updated
    February 4, 2023
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05727488
    Brief Title
    SARAH Exercise Program in Patients With Rheumatoid Arthritis
    Official Title
    Investigating the Effects of SARAH Exercise Program on Proprioception and Hand Functions in Patients With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 13, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Hand, Proprioception, Exercise

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Patients in the control group will not receive any exercise intervention. They will only maintain their routine medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Wrist Joint Position Sense
    Description
    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
    Title
    Change in Hand Performance
    Description
    Hand performance will be evaluated Nine-Hole Peg Test.
    Time Frame
    At baseline and twelve weeks later
    Title
    Change in Grip Strength
    Description
    Hand grip strength will be evaluated with a hand-dynamometer.
    Time Frame
    At baseline and twelve weeks later
    Title
    Change in Pinch Strength
    Description
    Pinch strength will be evaluated by using a pinchmeter.
    Time Frame
    At baseline and twelve weeks later
    Title
    Change in Self-reported Hand Functions
    Description
    Duruoz Hand Index and The Measures of Activity Performance of the Hand (MAP-Hand) Questionnaire will be used for subjective assessment of hand functions.
    Time Frame
    At baseline and twelve weeks later
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    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
    Title
    Change in Morning Stiffnes
    Description
    Morning stiffness related to the hand/wrist of the patients will be questioned in terms of duration and severity.
    Time Frame
    At baseline and twelve weeks later
    Title
    Change in Disease Activity
    Description
    Disease Activity 28 C-Reactive Proten (DAS28-CRP) will be used to evaluate disease activity.
    Time Frame
    At baseline and twelve weeks later
    Title
    Change in General Functioning
    Description
    Health Assesments Questionnaire-Disability Index (HAQ-DI), which is a self-report tool and has 20 items, will be used to evaluate the general functioning.
    Time Frame
    At baseline and twelve weeks later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: RA diagnosis according to 2010 ACR/EULAR RA criteria Being between the ages of 18-65 Being able to follow Turkish instructions Volunteering to participate in the study Exclusion Criteria: Being in an acute disease exacerbation period Ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months History of steroid injection, surgery, or trauma to the upper extremity in the last 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alper Ceylan, PT, BSc
    Phone
    +90 212 444 85 44
    Ext
    2521
    Email
    alperceylan96@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deniz Bayraktar, PT, PhD
    Organizational Affiliation
    Izmir Katip Celebi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available upon reasonable requests.
    IPD Sharing Time Frame
    Data will be available after completing the study and will be available for 20 years.
    IPD Sharing Access Criteria
    Data will be shared for only academic purposes (for conducting a meta-analysis or a systematic review)
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