Aerobic Exercise for Women With Fibromyalgia

NCT05550883 | Completed

• 1 other identifier: AEFIBRO2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in cholesterol level level

  baseline and 6 weeks

• Changes in Fibromyalgia Impact Questionnaire

  baseline and 6 weeks

Study Arms (2)

Group A (aerobic exercise group)

EXPERIMENTAL

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

Other: Aerobic exercise; Drug: Fibromyalgia Agents

Group B (Medications group)

ACTIVE COMPARATOR

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.

Drug: Fibromyalgia Agents

Interventions

Aerobic exercise OTHER

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.

Group A (aerobic exercise group)

Fibromyalgia Agents DRUG

tricyclic antidepressants (low evening doses), and mostly when needed, low doses of: analgesics, muscle relaxants, hypnotics, and tranquilizers.

Group A (aerobic exercise group); Group B (Medications group)

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Abu-kabir central hosptial

Al Mansurah, Al Sharquia, 12611, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Heba Abdeen, Ph.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: January 15, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

EG (1)