Effects of a Isokinetic Exercise in Women With Fibromyalgia

Официальное название

Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Exercise
  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 fini

Первичные конечные точки

• Peak torque [Срок оценки: Baseline, up to study completion (8 weeks); week 9]
• Peak torque [Срок оценки: Baseline, up to study completion (8 weeks); week 9]
• Agonist-antagonist ratio [Срок оценки: Baseline, up to study completion (8 weeks); week 9]
• Total work [Срок оценки: Baseline, up to study completion (8 weeks); week 9.]
• Height [Срок оценки: Baseline, week 9]

Вторичные конечные точки (12)

• Muscle electrical activity (amplitude) [Срок оценки: Baseline, week 9]
• Muscle electrical activity (frequency) [Срок оценки: Baseline, week 9]
• Muscle electrical activity (amplitude) [Срок оценки: Baseline, week 9]
• Muscle electrical activity (frequency) [Срок оценки: Baseline, week 9]
• Weight [Срок оценки: Baseline, week 9]
• Body composition (Bioimpedance) [Срок оценки: Baseline, week 9.]
• Muscle thickness [Срок оценки: Baseline, week 9.]
• Muscle thickness [Срок оценки: Baseline, week 9.]
• Pain score [Срок оценки: Baseline, up to study completion (8 weeks); week 9.]
• Pain location [Срок оценки: Baseline, up to study completion (8 weeks); week 9.]
• Quality of life: Short Form 36 Health Survey [Срок оценки: Baseline, week 9.]
• Quality of life: EuroQOL five dimensions questionnaire [Срок оценки: Baseline, week 9.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Miguel de Cervantes European University — Valladolid

Публикации

• 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. PMID 36202386
• 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. PMID 31987552
• 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. PMID 38205550
• 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. PMID 26084281
• 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. PMID 35604435
• 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. PMID 35725780
• 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. PMID 32721388
• 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. PMID 29291206

Идентификаторы

NCT: NCT07483216 · PI-DOC012-FibrodEx

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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