Back to resultsAerobic Exercise for Women With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise
Fibromyalgia Agents
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
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
Sites / Locations
- Abu-kabir central hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A (aerobic exercise group)
Group B (Medications group)
Arm Description
aerobic exercise training for 45 minutes, three sessions per week for 6 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in cholesterol level level
Blood sample to measure cholesterol level for each participant in both groups before and after treatment.
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.
Full Information
NCT ID
NCT05550883
First Posted
September 20, 2022
Last Updated
September 21, 2022
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT05550883
Brief Title
Aerobic Exercise for Women With Fibromyalgia
Official Title
Effectiveness of Aerobic Exercises for Women With Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (aerobic exercise group)
Arm Type
Experimental
Arm Description
aerobic exercise training for 45 minutes, three sessions per week for 6 weeks.
Arm Title
Group B (Medications group)
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fibromyalgia Agents
Intervention Description
tricyclic antidepressants (low evening doses), and mostly when needed, low doses of: analgesics, muscle relaxants, hypnotics, and tranquilizers.
Primary Outcome Measure Information:
Title
Changes in Visual analogue scale
Description
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.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Changes in cholesterol level level
Description
Blood sample to measure cholesterol level for each participant in both groups before and after treatment.
Time Frame
baseline and 6 weeks
Title
Changes in Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Abdeen, Ph.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abu-kabir central hosptial
City
Mansoura
State/Province
Al Sharquia
ZIP/Postal Code
12611
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Aerobic Exercise for Women With Fibromyalgia
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