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Recruiting NCT07483216

Effects of a Isokinetic Exercise in Women With Fibromyalgia

No phase Interventional Fibromyalgia (FM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Fibromyalgia (FM). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia

Overview

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

  • Other 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

Primary outcome measures

  • Peak torque [Time frame: Baseline, up to study completion (8 weeks); week 9]
  • Peak torque [Time frame: Baseline, up to study completion (8 weeks); week 9]
  • Agonist-antagonist ratio [Time frame: Baseline, up to study completion (8 weeks); week 9]
  • Total work [Time frame: Baseline, up to study completion (8 weeks); week 9.]
  • Height [Time frame: Baseline, week 9]
Secondary outcome measures (12)
  • Muscle electrical activity (amplitude) [Time frame: Baseline, week 9]
  • Muscle electrical activity (frequency) [Time frame: Baseline, week 9]
  • Muscle electrical activity (amplitude) [Time frame: Baseline, week 9]
  • Muscle electrical activity (frequency) [Time frame: Baseline, week 9]
  • Weight [Time frame: Baseline, week 9]
  • Body composition (Bioimpedance) [Time frame: Baseline, week 9.]
  • Muscle thickness [Time frame: Baseline, week 9.]
  • Muscle thickness [Time frame: Baseline, week 9.]
  • Pain score [Time frame: Baseline, up to study completion (8 weeks); week 9.]
  • Pain location [Time frame: Baseline, up to study completion (8 weeks); week 9.]
  • Quality of life: Short Form 36 Health Survey [Time frame: Baseline, week 9.]
  • Quality of life: EuroQOL five dimensions questionnaire [Time frame: Baseline, week 9.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Miguel de Cervantes European University — Valladolid

Publications

  • 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

Identifiers

NCT: NCT07483216 · PI-DOC012-FibrodEx

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗