Supervised and Home Training in Fibromyalgia

NCT ID: NCT06956456

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-06-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised Multicomponent Training (SMCT)

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

Group Type: EXPERIMENTAL

Supervised Multicomponent Training Protocol

Intervention Type: OTHER

Supervised Multicomponent Training Protocol

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Non-Supervised Home-Based Multicomponent Training (NSMCT)

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.

Group Type: EXPERIMENTAL

Non-Supervised Home-Based Multicomponent Training Protocol

Intervention Type: OTHER

Participant will receive a personalized exercise plan tailored to their fitness level.

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Waiting List Control Group (WLCG)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supervised Multicomponent Training Protocol

Supervised Multicomponent Training Protocol

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Intervention Type: OTHER

Non-Supervised Home-Based Multicomponent Training Protocol

Participant will receive a personalized exercise plan tailored to their fitness level.

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari Aldo Moro

OTHER

Sponsor Role: lead

Responsible Party

Luca Poli

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Poli, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bari Aldo Moro

Locations

Società Ginnastica Angiulli

Bari, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

7595

Identifier Type: -

Identifier Source: org_study_id