Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06956456
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supervised and Home Training in Fibromyalgia
Sponsor:
University of Bari Aldo Moro
Organization:
Study Overview
Official Title:
Effects of a 12-week Supervised or Home-based Multicomponent Training Program on Psychological, and Physical Variables in Fibromyalgia Patients
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: