Strength Training Protocol in Fibromyalgia Women (FM PROTOCOL)

Catholic University of Murcia

Status: Completed

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

Treatments: Behavioral: HG (Healthy group); Behavioral: FMG (Fibromyalgia group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06393790

TC/03-23 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Strength training group with fibromyalgia diagnosis

Experimental group

Description:

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.

Treatment:

Behavioral: FMG (Fibromyalgia group)

Strength training group in no fibromyalgia women

Active Comparator group

Description:

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.

Treatment:

Behavioral: HG (Healthy group)