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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | An isokinetic exercise program of microdosing will be conducted over 8 weeks, with a frequency of three sessions per week, each lasting 20-25 minutes. Participants will also receive information on healthy lifestyle habits. |
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| Control group | No Intervention | Participants assigned to the control group will continue with their usual treatment and will receive general recommendations for healthy lifestyle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, up to study completion (8 weeks); week 9 |
| 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. | Baseline, up to study completion (8 weeks); week 9 |
| Agonist-antagonist ratio | The change in the agonist-antagonist ratio (%) of the knee extension exercise will be assessed using the Biodex System 4. | Baseline, up to study completion (8 weeks); week 9 |
| Total work | The change in the total work (in J) of the knee extension exercise will be assessed using the Biodex System 4. | Baseline, up to study completion (8 weeks); week 9. |
| Height | The change in the height will be assessed by centimeters (cm). | Baseline, week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Santos Lozano, PhD | Contact | 0034983001000 | 22292 | asantos@uemc.es |
| Sergio Maroto Izquierdo, PhD | Contact | 0034983001000 | 22292 | smaroto@uemc.es |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Santos Lozano, PhD | Miguel de Cervantes European University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miguel de Cervantes European University | Recruiting | Valladolid | Valladolid | 47012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36202386 | Background | Afonso J, Nakamura FY, Baptista I, Rendeiro-Pinho G, Brito J, Figueiredo P. Microdosing: Old Wine in a New Bottle? Current State of Affairs and Future Avenues. Int J Sports Physiol Perform. 2022 Oct 6;17(11):1649-1652. doi: 10.1123/ijspp.2022-0291. Print 2022 Nov 1. | |
| 31987552 | Background | Tavares LF, Germano Maciel D, Pereira Barros da Silva TY, Brito Vieira WH. Comparison of functional and isokinetic performance between healthy women and women with fibromyalgia. J Bodyw Mov Ther. 2020 Jan;24(1):248-252. doi: 10.1016/j.jbmt.2019.05.024. Epub 2019 May 23. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Prospective single center randomized controlled trial
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The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
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|
| 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. |
| Baseline, week 9 |
| 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. | Baseline, week 9 |
| 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. | Baseline, week 9 |
| Weight | The change in the weight will be assessed by kilograms (kg). | Baseline, week 9 |
| Body composition (Bioimpedance) | 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. | Baseline, week 9. |
| Muscle thickness | 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. | Baseline, week 9. |
| Muscle thickness | 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. | Baseline, week 9. |
| Pain score | 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." | Baseline, up to study completion (8 weeks); week 9. |
| Pain location | 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. | Baseline, up to study completion (8 weeks); week 9. |
| Quality of life: Short Form 36 Health Survey | 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. | Baseline, week 9. |
| Quality of life: EuroQOL five dimensions questionnaire | 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). | Baseline, week 9. |
| Sleep quality | 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. | Baseline, week 9. |
| Physical activity levels | 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. | Baseline, week 9. |
| Heart rate variability | 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. | Baseline, week 9. |
| Interleukin-6 (IL-6) levels | 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). | Baseline, week 9. |
| Tumor necrosis factor-alpha (TNF-α) levels | 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). | Baseline, week 9. |
| C-reactive protein (CRP) levels | 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). | Baseline, week 9. |
| Cortisol | 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). | Baseline, week 9. |
| Glucose | 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). | Baseline, week 9. |
| Testosterone (total) | 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). | Baseline, week 9. |
| Testosterone (free) | 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). | Baseline, week 9. |
| Sex hormone-binding globulin | 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). | Baseline, week 9. |
| Dehydroepiandrosterone sulfate | 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). | Baseline, week 9. |
| Fibromyalgia Impact Questionnaire | 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. | Baseline, week 9. |
| Nutritional intake: Consume frequency | 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. | Baseline, week 9. |
| Nutritional intake: 24-hour register | 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. | Baseline, week 9. |
| Canadian Occupational Performance Measure | 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). | Baseline, week 9. |
| Goal Attainment Scaling | 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. | Baseline, week 9. |
| 38205550 | Background | Voss AC, Chambers TL, Gries KJ, Jemiolo B, Raue U, Minchev K, Begue G, Lee GA, Trappe TA, Trappe SW. Exercise microdosing for skeletal muscle health applications to spaceflight. J Appl Physiol (1985). 2024 May 1;136(5):1040-1052. doi: 10.1152/japplphysiol.00491.2023. Epub 2024 Jan 11. |
| 26084281 | Background | Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1. |
| 35604435 | Background | Albuquerque MLL, Monteiro D, Marinho DA, Vilarino GT, Andrade A, Neiva HP. Effects of different protocols of physical exercise on fibromyalgia syndrome treatment: systematic review and meta-analysis of randomized controlled trials. Rheumatol Int. 2022 Nov;42(11):1893-1908. doi: 10.1007/s00296-022-05140-1. Epub 2022 May 23. |
| 35725780 | Background | Couto N, Monteiro D, Cid L, Bento T. Effect of different types of exercise in adult subjects with fibromyalgia: a systematic review and meta-analysis of randomised clinical trials. Sci Rep. 2022 Jun 20;12(1):10391. doi: 10.1038/s41598-022-14213-x. |
| 32721388 | Background | Estevez-Lopez F, Maestre-Cascales C, Russell D, Alvarez-Gallardo IC, Rodriguez-Ayllon M, Hughes CM, Davison GW, Sanudo B, McVeigh JG. Effectiveness of Exercise on Fatigue and Sleep Quality in Fibromyalgia: A Systematic Review and Meta-analysis of Randomized Trials. Arch Phys Med Rehabil. 2021 Apr;102(4):752-761. doi: 10.1016/j.apmr.2020.06.019. Epub 2020 Jul 25. |
| 29291206 | Background | Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20. |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |