Strength Training Protocol in Fibromyalgia Women

NCT ID: NCT06393790

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-01-01

Brief Summary

Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.

The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.

In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.

Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.

Conditions

Fibromyalgia; Fatigue; Fatigue; Muscle, Heart; Strength Training; Stress

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Strength training group with fibromyalgia diagnosis

The sample will be composed of 15 subjects (women), aged between 18 and 70 years. Participants must have been diagnosed with fibromyalgia (FM) and/or chronic fatigue syndrome (CFS) at least three months before the start of the study.

Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

Group Type: EXPERIMENTAL

FMG (Fibromyalgia group)

Intervention Type: BEHAVIORAL

This intervention will report results of a strength training programme in people with fibromyalgia

Strength training group in no fibromyalgia women

The sample will be composed of 15 subjects (women), aged between 45 and 70 years. Participants must have not been diagnosed with fibromyalgia. These participants must be healthy individuals.

Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

Group Type: ACTIVE_COMPARATOR

HG (Healthy group)

Intervention Type: BEHAVIORAL

This intervention will report results of a strength training programme in people with no fibromyalgia diagnosis

Interventions

FMG (Fibromyalgia group)

This intervention will report results of a strength training programme in people with fibromyalgia

Intervention Type: BEHAVIORAL

HG (Healthy group)

This intervention will report results of a strength training programme in people with no fibromyalgia diagnosis

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women previously diagnosed with fibromyalgia and healthy women aged 18-75 years.
• Not be undertaking any physical activity or exercise programme for at least three months prior to the start of the protocol.

Exclusion Criteria

• Participants in the study may not present any other illness and/or injury at the time of the assessments that would prevent them from carrying out the activity. In the same way, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Extremadura

OTHER

Sponsor Role: collaborator

Catholic University of Murcia

OTHER

Sponsor Role: lead

Responsible Party

Carmen Daniela Quero Calero

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Facultad Deporte Universidad Católica San Antonio de Murcia

Murcia, España, Spain

Countries

Spain

Other Identifiers

TC/03-23

Identifier Type: REGISTRY

Identifier Source: secondary_id

TC/03-23

Identifier Type: -

Identifier Source: org_study_id