Effects of a Isokinetic Exercise in Women With Fibromyalgia
ConditionFibromyalgia (FM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean University Miguel de Cervantes
About this trial
Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged ≥ 18 years diagnosed with fibromyalgia according to current clinical criteria.
Clinical and pharmacological stability during the weeks prior to participation in the study.
Ability to perform supervised exercise and to complete the assessments.
Written informed consent.
Disqualifiers
Cardiovascular, neurologic, musculoskeletal or systemic pathology that contraindicate the performance of exercise.
Significant change in pharmacological treatment during the period immediately preceding the study.
Any condition that, in clinical judgement, prevents them from following the protocol safely.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionParticipants assigned to the experimental group will perform the sessions under supervision. Each session will begin with a warm-up consisting of joint mobility exercises and 5 minutes of low-intensity cycling. This will be followed by the main exercise component, which will consist of one set of five repetitions of knee extension exercise. During the initial sessions, the exercise will be performed at 60°/s, with a gradual and controlled progression up to a maximum of eight repetitions. To finish, participants will complete 5 minutes of stretching and controlled breathing.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Peak torque
The change in the peak torque (in Nm) will be assessed in the concentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Time frame
Baseline, up to study completion (8 weeks); week 92
Peak torque
The change in the peak torque (in Nm) will be assessed in the eccentric part of a knee extension exercise (1x5) at 60º/s using the Biodex System 4.
Time frame
Baseline, up to study completion (8 weeks); week 93
Agonist-antagonist ratio
The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4.
Time frame
Baseline, up to study completion (8 weeks); week 94
Total work
The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4.
Time frame
Baseline, up to study completion (8 weeks); week 9.Secondary outcomes
1
Muscle electrical activity (amplitude)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in vastus lateralis (in microvolts) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Time frame
Baseline, week 92
Muscle electrical activity (frequency)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in vastus lateralis (in Hz) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Time frame
Baseline, week 93
Muscle electrical activity (amplitude)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in rectus femoris (in microvolts) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Time frame
Baseline, week 94
Muscle electrical activity (frequency)
The MuscleLab system with electromyography will be used to measure muscle electrical activity in in rectus femoris bilateral (in Hz) recording during exercise, following the standard recommendations for electrode placement and with signal normalization.
Time frame
Baseline, week 9Sponsors and contacts
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Source ClinicalTrials.gov