Arm Exercise Capacity, Muscle Strength and Activities of... | NCT06678932

Studies
Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome

NCT06678932

Sponsor

Kirsehir Ahi Evran Universitesi

Status

Not yet recruiting

Last Update Posted

Nov 7, 2024Actual

Enrollment

36Estimated

Phase

Not provided

Conditions

Fibromyalgia Syndrome

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2024Estimated

Primary Completion Date

May 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Nov 6, 2024

First Submission Date that Met QC Criteria

Nov 6, 2024

First Posted Date

Nov 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2024

Last Update Posted Date

Nov 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Upper extremity exercise capacity	This will be evaluated with arm ergometer test.	1st day
Muscle strength	Hand grip strength will be measured using a hand grip dynamometer.	1st day
Muscle endurance	30 second push-up test will be used, and total number will be recorded.	1st day
Activities of daily living	It will be evaluated with the Glittre Activities of Daily Living test, and total time will be recorded.	1st day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria-fibromyalgia syndrome:

Being diagnosed with fibromyalgia syndrome
Being aged 18-65
Stable use of medication for at least 3 months or longer
Volunteering to participate in the study

Exclusion Criteria-fibromyalgia syndrome:

Having comorbidities that may affect physical functions
Failure to cooperate with tests to be performed
Presence of exercise test contraindication

Inclusion Criteria-healthy control:

Being aged 18-65
Volunteering to participate in the study

Exclusion Criteria-healthy control:

Having a chronic or systemic disease
Failure to cooperate with tests to be performed

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with fibromyalgia syndrome and healthy individuals will be included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merve Firat	Contact	+90 850 441 02 44		mervefirat@ahievran.edu.tr

Overall Officials

Name	Affiliation	Role
Basak Kavalci Kol	Kirsehir Ahi Evran University	Study Chair
Figen Tuncay	Kirsehir Ahi Evran University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kirsehir Ahi Evran University		Kırşehir			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Fibromyalgia syndrome
Healthy controls