NCT05946356

Brief Summary

This study aims to investigate the association between psychological wellbeing, physical activity, and disability in patients with fibromyalgia. Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. The study will use descriptive statistics, correlation analysis, and multiple regression analysis to analyze the data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 7, 2023

Last Update Submit

July 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Depression, Anxiety, and Stress Scale (DASS)

    epression, Anxiety, and Stress Scale (DASS) is a self-report questionnaire that is used to assess the severity of depression, anxiety, and stress. The DASS consists of 42 items that are scored on a scale of 0 to 3, with 0 indicating "not at all" and 3 indicating "severely." The total score for the DASS is the sum of the scores for the 42 items. A higher score indicates more severe symptoms of depression, anxiety, or stress.

    Baseline

  • International Physical Activity Questionnaire (IPAQ)

    International Physical Activity Questionnaire (IPAQ) is a self-report questionnaire that is used to assess physical activity levels. The IPAQ consists of 7 questions that ask about the frequency, duration, and intensity of physical activity. The IPAQ can be used to assess physical activity levels in people of all ages and activity levels.

    Baseline

  • Fibromyalgia Impact Questionnaire (FIQ)

    is a self-report questionnaire that is used to measure disability in patients with fibromyalgia. The FIQ consists of 21 items that ask about the impact of fibromyalgia on physical function, social function, and role function. The FIQ can be used to assess the severity of fibromyalgia and to monitor the effectiveness of treatment.

    Baseline

Study Arms (1)

Fibromyalgia patients

Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability.

Other: no intervention - cross-sectional observational only

Interventions

no intervention - cross-sectional observational only

Fibromyalgia patients

Eligibility Criteria

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

Patients diagnosed with fibromyalgia

You may qualify if:

  • Diagnosis of fibromyalgia
  • Age between 18 and 70 years old

You may not qualify if:

  • Unable to complete self-reported questionnaires
  • Presence of other chronic pain conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 14, 2023

Study Start

July 15, 2023

Primary Completion

November 25, 2023

Study Completion

December 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations