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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.
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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.
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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.
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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.
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Weight
Time frame: Baseline, week 9
The change in the weight will be assessed by kilograms (kg).
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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.
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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.
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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.
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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."
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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.
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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.
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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).
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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.
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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.
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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.
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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).
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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).
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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).
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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).
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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).
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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).
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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).
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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).
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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).
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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.
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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.
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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.
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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).
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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.