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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05550883
Other study ID # AEFIBRO2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date September 1, 2022

Study information

Verified date September 2022
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise
The patients in this group participated in aerobic exercise training for 45 minutes, three sessions per week for 6 weeks. They underwent the proper warm up to minimize the risk of musculoskeletal injury .The training session started by a proper warm up for 5 min in the form of mild stretching for the involved muscle group to prepare the exercised muscles and improve blood supply for skeletal muscle to prevent fatigue or injury. Patients in this study group performed aerobic exercise (in the form of treadmill training) All sessions were supervised to ensure correct technique and monitor the appropriate amount of exercise. The training session ended by a proper cooling down for 5 min to prevent fatigue or injury.
Drug:
Fibromyalgia Agents
tricyclic antidepressants (low evening doses), and mostly when needed, low doses of: analgesics, muscle relaxants, hypnotics, and tranquilizers.

Locations

Country Name City State
Egypt Abu-kabir central hosptial Mansoura Al Sharquia

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in 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. baseline and 6 weeks
Secondary Changes in cholesterol level level Blood sample to measure cholesterol level for each participant in both groups before and after treatment. baseline and 6 weeks
Secondary Changes in Fibromyalgia Impact Questionnaire This questionnaire was designed to assess the current health status of patients with fibromyalgia. The FIQ has 11 individual questions and measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week ranging from 0-100 with higher score indicating more severity. baseline and 6 weeks
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