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Clinical Trials/NCT05550883
NCT05550883
Completed
Not Applicable

Effectiveness of Aerobic Exercises for Women With Fibromyalgia: a Randomized Controlled Trial

October 6 University1 site in 1 country60 target enrollmentJanuary 15, 2022

Overview

Phase
Not Applicable
Intervention
Aerobic exercise
Conditions
Fibromyalgia
Sponsor
October 6 University
Enrollment
60
Locations
1
Primary Endpoint
Changes in Visual analogue scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This is randomized controlled trial that investigated the effect of aerobic exercises in women with fibromyalgia. The study was performed in Abu-kabir central hospital - Al Sharquia, Egypt. The sample was recruited from the rheumatology department in Abu-kabir central hospital- Al Sharquia. Sixty women were included in the study based on the inclusion criteria. The first group (study group) included 30 participants who received aerobic exercise in addition to the prescribed medications. The second group (control group) included 30 participants who received the prescribed medications only. The outcome measures included visual analogue scale, Fibromyalgia Impact Questionnaire and cholesterol level. Assessment of outcomes were performed at baseline and after the end of treatment program.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

Ahram Canadian University

Eligibility Criteria

Inclusion Criteria

  • (1)Their ages ranged from 30 to 40 years old (2)Their body mass index (BMI) was from 20:26 kg/m2 (3)All patients assured diagnosis fibromyalgia for more than three months (4)Participants were on a stable regimen of pharmacological and/or non pharmacological treatment for FM the previous three months leading up to study period and agree to maintain their present medication unchanged for the duration of their participation in the study

Exclusion Criteria

  • Patients with pregnancy, another accompanying central sensitization syndrome Patients with psychiatric illness Patients whose pharmacological treatment for FMS changed within the last three months Patients who do not have a cognitive level to answer the questions in the scale

Arms & Interventions

Group A (aerobic exercise group)

aerobic exercise training for 45 minutes, three sessions per week for 6 weeks.

Intervention: Aerobic exercise

Group A (aerobic exercise group)

aerobic exercise training for 45 minutes, three sessions per week for 6 weeks.

Intervention: Fibromyalgia Agents

Group B (Medications group)

The patients in this group did not receive treatment program. just received their medical treatment tricyclic antidepressants (low evening doses), and mostly when needed, low doses of: analgesics, muscle relaxants, hypnotics, and tranquilizers over the period of 6 weeks.

Intervention: Fibromyalgia Agents

Outcomes

Primary Outcomes

Changes in Visual analogue scale

Time Frame: baseline and 6 weeks

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.

Secondary Outcomes

  • Changes in cholesterol level level(baseline and 6 weeks)
  • Changes in Fibromyalgia Impact Questionnaire(baseline and 6 weeks)

Study Sites (1)

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