SARAH Exercise Program in Patients With Rheumatoid Arthritis

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05727488
Collaborator
(none)
76
2
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Investigating the Effects of SARAH Exercise Program on Proprioception and Hand Functions in Patients With Rheumatoid Arthritis
Anticipated Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise Group

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
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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Change in Wrist Joint Position Sense [At baseline and twelve weeks later]

    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.

  2. Change in Hand Performance [At baseline and twelve weeks later]

    Hand performance will be evaluated Nine-Hole Peg Test.

  3. Change in Grip Strength [At baseline and twelve weeks later]

    Hand grip strength will be evaluated with a hand-dynamometer.

  4. Change in Pinch Strength [At baseline and twelve weeks later]

    Pinch strength will be evaluated by using a pinchmeter.

  5. Change in Self-reported Hand Functions [At baseline and twelve weeks later]

    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

  1. Change in Pain [At baseline and twelve weeks later]

    Numeric rating scale (NRS) will be used for pain assessment. NRS is scored between 0-10 and, higher scores indicate higher level of pain.

  2. Change in Morning Stiffnes [At baseline and twelve weeks later]

    Morning stiffness related to the hand/wrist of the patients will be questioned in terms of duration and severity.

  3. Change in Disease Activity [At baseline and twelve weeks later]

    Disease Activity 28 C-Reactive Proten (DAS28-CRP) will be used to evaluate disease activity.

  4. Change in General Functioning [At baseline and twelve weeks later]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. RA diagnosis according to 2010 ACR/EULAR RA criteria

  2. Being between the ages of 18-65

  3. Being able to follow Turkish instructions

  4. Volunteering to participate in the study

Exclusion Criteria:
  1. Being in an acute disease exacerbation period

  2. Ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months

  3. History of steroid injection, surgery, or trauma to the upper extremity in the last 6 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

  • Principal Investigator: Deniz Bayraktar, PT, PhD, Izmir Katip Celebi University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Deniz Bayraktar, Assistant Professor, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT05727488
Other Study ID Numbers:
  • SARAHRA
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deniz Bayraktar, Assistant Professor, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023