Supervised and Home Training in Fibromyalgia

University of Bari Aldo Moro

Status: Active, not recruiting

Conditions: Fibromyalgia

Treatments: Other: Non-Supervised Home-Based Multicomponent Training Protocol; Other: Supervised Multicomponent Training Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06956456

7595

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effectiveness of supervised multicomponent training (MCT) on physiological parameters, physical fitness, mental well-being, and quality of life in subjects with a history of Fibromyalgia, compared to a non-supervised home-based MCT protocol and a waitlist control group (WLCG). The main questions it aims to answer are:

Does supervised MCT or non-supervised home-based MCT protocol improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does supervised MCT provide superior physiological an psychological improvements compared to a non-supervised home-based MCT protocol?

Researchers will compare:

supervised MCT (a combination of aerobic, mobility, and resistance training exercises) and non-supervised home-based MCT protocol to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant differences between supervised MCT and non-supervised home-based MCT protocol.

Participants will:

Complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (T0) and after 12 weeks (T1).

Be randomly assigned to one of three groups.

Engage in a 12-week of non-supervised home-based MCT protocol or structured MCT program supervised by exercise professionals, including:

Warm-up sessions (10 minutes, low-intensity walking). Main sessions (40 minutes): aerobic, mobility, resistance (MCT), only-aerobic (AT) exercises.

Cool-down sessions (10 minutes): breathing and stretching exercises.

This study will provide insights into the efficacy of tailored physical activity interventions for Fibromyalgic patients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women/Men
• Diagnosis of fibromyalgia
• Age between 18 and 75 years at the time of initial treatment;
• Signature of a written informed consent form (or their legally recognized representatives must sign) indicating that the patient understood the purpose and procedures required for the study and is willing to participate in the study;
• Sedentary lifestyle (subjects who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months);
• Positive medical specialist assessment of noncompetitive physical activity practice

Exclusion criteria

• Expected absence for more than one week during the intervention period
• Absence of a medical certificate of suitability for non-competitive sports
• Severe musculoskeletal or joint disorders with significant mobility limitations
• Uncontrolled hypertension or untreated heart disease;
• Pshychiatric disorders;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Supervised Multicomponent Training (SMCT)

Experimental group

Description:

subjects assigned to the SMCT group will perform a supervised training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components.

Treatment:

Other: Supervised Multicomponent Training Protocol

Non-Supervised Home-Based Multicomponent Training (NSMCT)

Experimental group

Description:

subjects assigned to the NSMCT group will perform a non-supervised home-based training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components.

Treatment:

Other: Non-Supervised Home-Based Multicomponent Training Protocol

Waiting List Control Group (WLCG)

No Intervention group

Description:

Subjects assigned to the WLCG group will not engage in any structured physical activity throughout the intervention period, continuing with their usual lifestyle, and will be placed on a waiting list, ensuring their participation in adapted physical activity at the end of the 12-week intervention.