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NCT Number: NCT07483216

Effects of a Isokinetic Exercise in Women With Fibromyalgia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Miguel de Cervantes European University

Valladolid, 47012, Spain

Location status: Recruiting

Location contact

Alejandro Santos Lozano, PhD

CONTACT

[email protected]

0034983001000 ext. 22292

Celia García Chico, PhD

SUB_INVESTIGATOR

Francisco Javier Gutiérrez Pecharromán, PhD

CONTACT

[email protected]

0034983001000 ext. 22293

Francisco Javier Iruzubieta Barragán, PhD

SUB_INVESTIGATOR

Irati Jauregui Fajardo, MSc

SUB_INVESTIGATOR

Kayvan Khoramipour, PhD

SUB_INVESTIGATOR

María Merino País, MSc

SUB_INVESTIGATOR

Olga Isabel Fernández Rodríguez, PhD

SUB_INVESTIGATOR

Paula Crespo Escobar, PhD

SUB_INVESTIGATOR

Paula Redondo Delgado, MSc

SUB_INVESTIGATOR

Sergio Maroto Izquierdo, PhD

SUB_INVESTIGATOR

Susana López Ortiz, PhD

SUB_INVESTIGATOR

About this study

Physical exercise is one of the non-pharmacological treatments with the strongest evidence and effectiveness in the management of fibromyalgia, as it has been shown to improve muscle strength and, consequently, patients' quality of life. One of the main limitations in this population is low adherence to traditional exercise programs due to chronic pain. Microdoses exercise training emerges as an alternative approach, based on the principle of the minimum effective dose. To implement this intervention, the training program will be conducted using isokinetic exercise, which allows precise control of movement velocity and joint position to ensure safe conditions. Accordingly, the aim of the present study is to evaluate the effects of an isokinetic exercise microdosing program in women with fibromyalgia over an 8-week intervention period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Exercise

Other

Participants 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.

Primary outcomes

  1. Peak torque

    Time frame: Baseline, up to study completion (8 weeks); week 9

    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.

  2. Peak torque

    Time frame: Baseline, up to study completion (8 weeks); week 9

    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.

  3. Agonist-antagonist ratio

    Time frame: Baseline, up to study completion (8 weeks); week 9

    The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4.

  4. Total work

    Time frame: Baseline, up to study completion (8 weeks); week 9.

    The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4.

  5. Height

    Time frame: Baseline, week 9

    The change in the height will be assessed by centimeters (cm).

Secondary outcomes

  1. Muscle electrical activity (amplitude)

    Time frame: Baseline, week 9

    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.

  2. Muscle electrical activity (frequency)

    Time frame: Baseline, week 9

    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.

  3. Muscle electrical activity (amplitude)

    Time frame: Baseline, week 9

    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.

  4. Muscle electrical activity (frequency)

    Time frame: Baseline, week 9

    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.

  5. Weight

    Time frame: Baseline, week 9

    The change in the weight will be assessed by kilograms (kg).

  6. Body composition (Bioimpedance)

    Time frame: Baseline, week 9.

    The change in body composition (%) will be assessed using the NUTRILAB bioimpedance device (AKERN Srl, Florence, Italy). Users will be instructed to remove all metal-containing objects and remain in a supine position on a couch during the measurements, with the legs in 45° abduction, the shoulders in 30° abduction relative to the center of the body and the hands in pronation. After cleaning the skin with alcohol, two adhesive electrodes (Biatrodes Akern Srl, Florence, Italy) will be placed on the surface of the right hand and two on the right foot. The measurement results will be given in different unit measures depending on the specific variable assessed.

  7. Muscle thickness

    Time frame: Baseline, week 9.

    The change in the muscle thickness (in centimeters) of the vastus lateralis will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin.

  8. Muscle thickness

    Time frame: Baseline, week 9.

    The change in the muscle thickness (in centimeters) of the rectus femoris bilateral will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin.

  9. Pain score

    Time frame: Baseline, up to study completion (8 weeks); week 9.

    The change in the score of pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 "no pain at all" to 10 "worst pain imaginable."

  10. Pain location

    Time frame: Baseline, up to study completion (8 weeks); week 9.

    The pain location will be assessed using a body chart. The participant will identify using a graphical representation of the body the location of the pain, without indicating its intensity.

  11. Quality of life: Short Form 36 Health Survey

    Time frame: Baseline, week 9.

    The change in quality-of-life scores will be assessed using the Short Form 36 Health Survey (SF-36). This instrument consists of 36 items, organized into eight health domains, with a score ranging from 0 to 100.

  12. Quality of life: EuroQOL five dimensions questionnaire

    Time frame: Baseline, week 9.

    The change in quality-of-life scores will be assessed using the EuroQOL five-dimensions questionnaire (EQ-5D). This instrument consists of five dimensions and a visual analogue scale (VAS).The response types involve a Likert scale (1-5 for dimensions), multiple-choice (selecting the level), and a rating scale (0-100 for VAS).

  13. Sleep quality

    Time frame: Baseline, week 9.

    The change in sleep quality scores will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This index consists of 19 self-rated items, which are grouped into seven component scores, ranging from 0 to 21.

  14. Physical activity levels

    Time frame: Baseline, week 9.

    The levels of physical activity will be recorded using the International Physical Activity Questionnaire (score) a standardized tool that defines and measures physical activity based on frequency (days) and duration (minutes) over a week. It categorizes physical activity into vigorous-intensity, moderate-intensity, and walking, and also assesses time spent sitting.

  15. Heart rate variability

    Time frame: Baseline, week 9.

    The change in heart rate variability (HRV) will be measured in milliseconds (ms) to assess autonomic nervous system function. Participants will use a Polar H10 heart rate monitor (Polar Electro Oy, Kempele, Finland) with the Elite HRV app for 15 minutes.

  16. Interleukin-6 (IL-6) levels

    Time frame: Baseline, week 9.

    The change in the plasma concentration of interleukin-6 (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  17. Tumor necrosis factor-alpha (TNF-α) levels

    Time frame: Baseline, week 9.

    The change in the plasma concentration of tumor necrosis factor-alpha (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  18. C-reactive protein (CRP) levels

    Time frame: Baseline, week 9.

    The change in the plasma concentration of C-reactive protein (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  19. Cortisol

    Time frame: Baseline, week 9.

    Cortisol The change in the plasma concentration of cortisol (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  20. Glucose

    Time frame: Baseline, week 9.

    The change in the plasma concentration of glucose (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  21. Testosterone (total)

    Time frame: Baseline, week 9.

    The change in the plasma concentration of total testosterone (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  22. Testosterone (free)

    Time frame: Baseline, week 9.

    The change in the plasma concentration of free testosterone (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  23. Sex hormone-binding globulin

    Time frame: Baseline, week 9.

    The change in the plasma concentration of sex hormone-blinding globulin (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  24. Dehydroepiandrosterone sulfate

    Time frame: Baseline, week 9.

    The change in the plasma concentration of dehydroepiandrosterone sulfate (mg/l and/or ng/ml) will be assessed. Venous blood samples will be collected. The plasma concentrations will be analyzed using an enzyme-linked immunosorbent assay (ELISA).

  25. Fibromyalgia Impact Questionnaire

    Time frame: Baseline, week 9.

    The change in the score of the fibromyalgia impact will be assessed using the fibromyalgia impact questionnaire (FIQ), a 10-item questionnaire that covers Physical Function, Work Status, and Symptoms. The total score ranges from 0 to 100, a higher score (closer to 100) indicates a greater impact of fibromyalgia, signifying higher functional disability, more severe symptoms, and a worse quality of life. Conversely, a lower score (closer to 0) indicates a better health status.

  26. Nutritional intake: Consume frequency

    Time frame: Baseline, week 9.

    The change in the dietary intake (consume frequency) will be assessed with a Food Frequency Questionnaire (FFQ). This tool measures how often foods and food groups are consumed over a specific period, enabling the estimation of typical dietary patterns. The total days per week that a participant consumes a type of food will be recorded.

  27. Nutritional intake: 24-hour register

    Time frame: Baseline, week 9.

    The change in the dietary intake will be assessed with a 24-hour dietary recall . This tool measures how often foods and food groups are consumed over a specific period, enabling the estimation of typical dietary patterns.

  28. Canadian Occupational Performance Measure

    Time frame: Baseline, week 9.

    The change in the occupational performance score will we assessed using the Canadian Occupational Performance Measure (COPM). The participant will identify their priorities for activities in daily living. After priorities are identified, each is rated for current performance and satisfaction with current performance on a scale of 1 (not able to do it / not satisfied at all) to 10 (able to do it extremely well / extremely satisfied).

  29. Goal Attainment Scaling

    Time frame: Baseline, week 9.

    The change in the goal achievement progress will be assessed using Goal Attainment Scaling, a standardized individualized outcome measure in which five measurable outcomes are specified for each goal. The total score will range from -2 to 2.

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandro Santos Lozano, PhD

CONTACT

[email protected]

0034983001000 ext. 22292

Sergio Maroto Izquierdo, PhD

CONTACT

[email protected]

0034983001000 ext. 22292

Sponsors and collaborators

Lead sponsor

European University Miguel de Cervantes

Other

Registry information

Official study title

Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia

Acronym: FibrodEx

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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