Clinical trial NCT06956456: Supervised and Home Training in Fibromyalgia
Official title: Effects of a 12-week Supervised or Home-based Multicomponent Training Program on Psychological, and Physical Variables in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: mental and physical well-being
anxiety-depressive symptoms
fisical fitness
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change in lower body strength
timeFrame: 12-weeks
measure: Change in functional mobility
timeFrame: 12-weeks
measure: Change in Handrigp Strength
timeFrame: 12-weeks
measure: Change in aerobic capacity
timeFrame: 12-weeks
measure: Change in lower body flexibility
timeFrame: 12-weeks
measure: Change in upper body flexibility
timeFrame: 12-weeks
measure: Change in psychological parameters (depression)
timeFrame: 12-weeks
measure: Change in psychological parameters (anxiety).
timeFrame: 12-weeks
measure: Change in psychological parameters (enjoyment).
timeFrame: 12-weeks
measure: Change in psychological parameters (fear of movement).
timeFrame: 12-weeks
measure: Change in psychological parameters (anticipated pain).
timeFrame: 12-weeks
measure: Change in psychological parameters (alexithymia).
timeFrame: 12-weeks
measure: Change in physical activity levels.
timeFrame: 12-weeks
measure: Change in psychological parameters (pain severity).
timeFrame: 12-weeks
measure: Change in psychological parameters (pain intensity).
timeFrame: 12-weeks
measure: Change in psychological parameters (fatigue).
timeFrame: 12-weeks
measure: Change in psychological parameters (sleep quality).
timeFrame: 12-weeks
measure: Change in psychological parameters (psychophysical well-being).
timeFrame: 12-weeks
measure: Change in psychological parameters (fibromyalgia impact).
timeFrame: 12-weeks
measure: Cahnge in upper body strength
timeFrame: 12-weeks
measure: Change in body mass index
timeFrame: 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Società Ginnastica Angiulli
Study officials:
affiliation: University of Bari Aldo Moro
name: Luca Poli, Dr.
role: PRINCIPAL_INVESTIGATOR
References: