Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With RA

An observational study of Rheumatoid Arthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Rheumatoid Arthritis
How many people: 23 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Dec 2019to 10 Sep 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The population of the study consists of RA patients.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Izmir Katip Celebi University
Izmir, Izmir/ Cigli

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With Rheumatoid Arthritis

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.

Read the detailed description

Upper extremity functions affect the quality of life at different levels in patients with rheumatoid arthritis (RA). In the current literature; it has been shown that grip endurance is associated with upper limb functions. However, there is no study investigating the relationship between grip endurance and quality of life in patients with RA. The purpose of this study is to investigate the relationship between grip endurance, disability of upper extremity, and quality of life in patients with RA.

Conditions: Rheumatoid Arthritis
Keywords: Grip Endurance, DASH, Quality of Life, Rheumatoid Arthritis.
Medical subject headings: Arthritis, Rheumatoid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
This parameter was evaluated by Disability of Arm, Shoulder and Hand (DASH) questionairre.
Measured: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
Quality of Life Parameters
This parameter was evaluated by Short Form-36.
Measured: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201910 Sep 2020

First posted24 Sep 2020
Study start1 Dec 2019
Primary completion1 Apr 2020
Study completion10 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04563455
Sponsor's protocol ID: IzmirKatip Celebi University
Status last verified: Sep 2020
First submitted: 23 Sep 2020
Last updated: 24 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT04563455
Acronym / sponsor ID: IzmirKatip Celebi University
Conditions: Rheumatoid Arthritis
Keywords: Grip Endurance, DASH, Quality of Life, Rheumatoid Arthritis.
Study type: Observational
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Izmir Katip Celebi UniversityUniversity, hospital or other
Study start: 1 Dec 2019 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 10 Sep 2020 (actual)
First posted: 24 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The population of the study consists of RA patients.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Static Grip Endurance
Time frame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
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.
Dynamic Grip Endurance
Time frame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
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.

2 secondary outcomes

Disability of Upper Extremity
Time frame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
Quality of Life Parameters
Time frame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa KÖPRÜLÜOĞLU principal investigator

İzmir Katip Celebi University, Faculty of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static Grip Endurance (time frame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04563455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.