Fibromyalgia (FM)
Conditions
Keywords
Fibromyalgia, Exercise, Isokinetic, Microdosing, Pain, Non-Pharmacological treatment
Brief summary
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.
Detailed description
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.
Interventions
OTHERExercise
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.
Sponsors
European University Miguel de Cervantes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
Intervention model description
Prospective single center randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak torque | 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. |
| Agonist-antagonist ratio | 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. |
| Total work | 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. |
| Height | Baseline, week 9 | The change in the height will be assessed by centimeters (cm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle electrical activity (amplitude) | 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. |
| Muscle electrical activity (frequency) | 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. |
| Weight | Baseline, week 9 | The change in the weight will be assessed by kilograms (kg). |
| Body composition (Bioimpedance) | 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. |
| Muscle thickness | 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. |
| Pain score | 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." |
| Pain location | 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. |
| Quality of life: Short Form 36 Health Survey | 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. |
| Quality of life: EuroQOL five dimensions questionnaire | 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). |
| Sleep quality | 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. |
| Physical activity levels | 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. |
| Heart rate variability | 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. |
| Interleukin-6 (IL-6) levels | 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). |
| Tumor necrosis factor-alpha (TNF-α) levels | 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). |
| C-reactive protein (CRP) levels | 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). |
| Cortisol | 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). |
| Glucose | 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). |
| Testosterone (total) | 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). |
| Testosterone (free) | 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). |
| Sex hormone-binding globulin | 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). |
| Dehydroepiandrosterone sulfate | 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). |
| Fibromyalgia Impact Questionnaire | 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. |
| Nutritional intake: Consume frequency | 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. |
| Nutritional intake: 24-hour register | 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. |
| Canadian Occupational Performance Measure | 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). |
| Goal Attainment Scaling | 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. |
Countries
Spain
Contacts
CONTACTAlejandro Santos Lozano, PhD
CONTACTSergio Maroto Izquierdo, PhD
PRINCIPAL_INVESTIGATORAlejandro Santos Lozano, PhD
Miguel de Cervantes European University
Outcome results
None listed