NCT04563455

Brief Summary

The aim of this study is to investigate the relationship between grip endurance, disability of upper extremity and quality of life in patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 23, 2020

Last Update Submit

September 23, 2020

Conditions

Keywords

Grip Endurance, DASH, Quality of Life, Rheumatoid Arthritis.

Outcome Measures

Primary Outcomes (2)

  • Static Grip Endurance

    Static grip endurance was evaluated by Hand Dynamometer (Lafayette Proffessional Hand Dynamometer, USA). The maximum gripping time of 50% of the maximum grip force was recorded.

    Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

  • Dynamic Grip Endurance

    Dynamic grip endurance was evaluated by Hand Dynamometer (Lafayette Proffessional Hand Dynamometer, USA). The percentage change between the first 3 grips and the last 3 grips after 10 consecutive grips is recorded.

    Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

Secondary Outcomes (2)

  • Disability of Upper Extremity

    Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

  • Quality of Life Parameters

    Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the study consists of RA patients.

You may qualify if:

  • RA patients were classified according to the ACR 2010 criteria.
  • taking regular medication.

You may not qualify if:

  • having a history of trauma or surgery in the upper limb.
  • having neurological, cognitive, or psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Izmir/ Cigli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Melissa KÖPRÜLÜOĞLU

    İzmir Katip Celebi University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 24, 2020

Study Start

December 1, 2019

Primary Completion

April 1, 2020

Study Completion

September 10, 2020

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations