NCT04437524

Brief Summary

In this study, it was aimed to examine the effects of aerobic exercise and balance-proprioception exercises on pain, functionality and strength parameters of fibromyalgia patients and to compare the two exercise types.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

June 17, 2020

Last Update Submit

December 8, 2020

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength

Outcome Measures

Primary Outcomes (3)

  • Fibromyalgia Impact Questionnaire (FIQ)

    In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.

    6 weeks

  • Pain (Visual Analogue Scale)

    Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.

    6 weeks

  • Muscle Strength Evaluation

    The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.

    6 weeks

Study Arms (2)

balance-proprioception exercises group

ACTIVE COMPARATOR

balance-proprioception exercises group

Other: therapeutic exercises

aerobic exercises group

ACTIVE COMPARATOR

aerobic exercises group

Other: therapeutic exercises

Interventions

therapeutic exercisesOTHER

Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.

aerobic exercises groupbalance-proprioception exercises group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female fibromyalgia patients will be admitted to the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18 and 60,
  • Symptoms lasting longer than 3 months,
  • According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,
  • According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,
  • Acceptance of treatment that will continue 3 days a week for 6 weeks,
  • The possibility of any change in medical treatment due to FMS during the study is not foreseen.

You may not qualify if:

  • Known central or peripheral nervous system disease, progressive neurological damage,
  • Any serious cardiovascular pathology,
  • Sense, loss of sense of position, unhealed fracture or a surgical wound,
  • Presence of uncontrolled hypertension,
  • Failure to understand or perform simple commands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Faculty of Medicine, Department of Sports Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Gökhan Metin, Professor

    İstanbul Univesity, İstanbul Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 18, 2020

Study Start

August 24, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Locations

TU(1)