Effects of a Isokinetic Exercise in Women With Fibromyalgia

NCT07483216 | Recruiting

• 1 other identifier: PI-DOC012-FibrodEx
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia (FM)

Keywords

Fibromyalgia; Exercise; Isokinetic; Microdosing; Pain; Non-Pharmacological treatment

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (29)

• Muscle electrical activity (amplitude)

  Baseline, week 9

• Muscle electrical activity (frequency)

  Baseline, week 9

• Muscle electrical activity (amplitude)

  Baseline, week 9

• Muscle electrical activity (frequency)

  Baseline, week 9

• Weight

  Baseline, week 9

Study Arms (2)

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.

Other: Exercise

Control group

NO INTERVENTION

Participants assigned to the control group will continue with their usual treatment and will receive general recommendations for healthy lifestyle.

Interventions

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University Miguel de Cervantes: lead

Study Sites (1)

Miguel de Cervantes European University

Valladolid, Valladolid, 47012, Spain

RECRUITING

Related Publications (8)

• 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 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.

  PMID: 31987552 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.

  PMID: 38205550 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.

  PMID: 26084281 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.

  PMID: 35604435 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.

  PMID: 35725780 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.

  PMID: 32721388 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.

  PMID: 29291206 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alejandro Santos Lozano, PhD

  Miguel de Cervantes European University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Santos Lozano, PhD

CONTACT

0034983001000; asantos@uemc.es

Sergio Maroto Izquierdo, PhD

CONTACT

0034983001000; smaroto@uemc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The person analyzing the data collected (investigators, statisticians) will not know to which group each person belongs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single center randomized controlled trial

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)