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Completed

NCT Number: NCT05727488

SARAH Exercise Program in Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

About this study

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 rheumatoid arthritis (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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 outcomes

  1. Change in Wrist Joint Position Sense

    Time frame: 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

    Time frame: At baseline and twelve weeks later

    Hand performance will be evaluated Nine-Hole Peg Test.

  3. Change in Grip Strength

    Time frame: At baseline and twelve weeks later

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

  4. Change in Pinch Strength

    Time frame: At baseline and twelve weeks later

    Pinch strength will be evaluated by using a pinchmeter.

  5. Change in Self-reported Hand Functions

    Time frame: At baseline and twelve weeks later

    Duruoz Hand Index and The Measures of Activity Performance of the Hand Questionnaire will be used for subjective assessment of hand functions. Higher scores in both questionnaires reflect poorer hand functions.

Secondary outcomes

  1. Change in Pain

    Time frame: 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 Stiffness

    Time frame: At baseline and twelve weeks later

    Morning stiffness related to the hand/wrist of the patients will be questioned by using Numeric Rating Scale (0-10) in terms of duration and severity. Higher scores indicate worse morning stiffness.

  3. Change in Disease Activity

    Time frame: At baseline and twelve weeks later

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

  4. Change in General Functioning

    Time frame: At baseline and twelve weeks later

    Health Assessments Questionnaire-Disability Index, which is a self-report tool and has 20 items, will be used to evaluate the general functioning. All items are scored between 0 and 3. All scores are summed and divided by 20 to obtain a total score (0-3). Higher scores indicate a worse functional status.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Investigating the Effects of SARAH Exercise Program on Proprioception and Hand Functions in Patients With Rheumatoid Arthritis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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