- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07591766
Aerobic Dance Exercises in Fibromyalgia Syndrome
15 maggio 2026 aggiornato da: Tugba Civi Karaaslan, Istanbul University
The Effectiveness of Aerobic Dance Exercises in Fibromyalgia Syndrome: A Randomized Controlled Trial
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
A total of 44 female participants were included.
Group-1 (n=22) received aerobic dance exercises twice a week for eight weeks, while Group-2 (n=22) was given a conventional postural exercise program as a home-based intervention with the same duration and frequency.
To evaluate the participants, the following assessment tools were used: Fibromyalgia Impact Questionnaire, McGill-Melzack Pain Questionnaire, Short Form-36, Pittsburgh Sleep Quality Index, Beck Depression Inventory, International Physical Activity Questionnaire-Short Form, and Fatigue Severity Scale.
Both groups showed significant improvements in nearly all parameters after the intervention (p<0.05).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
44
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Istanbul, Turchia (Türkiye)
- Istanbul University-Cerrahpaşa
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- diagnosis of FMS according to the American College of Rheumatology (ACR) diagnostic criteria
- being female between the ages of 18 and 65
- having the physical capacity to exercise
Exclusion Criteria:
- unstable angina pectoris with severe dyspnea that would prevent exercise
- the presence of any neurological or orthopedic disease other than FMS
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Aerobic Dance Exercises
The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down.
These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm.
Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns.
A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations.
Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance.
The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo.
|
The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down.
These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm.
Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns.
A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations.
Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance.
The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo.
|
|
Sperimentale: Conventional Exercises
To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders.
This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week.
To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study.
|
To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders.
This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week.
To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fibromyalgia Impact Scale
Lasso di tempo: change from baseline at 8 weeks
|
To measure the impact of the disease on daily life, a 20-question assessment tool was utilized, focusing on domains such as physical capacity, occupational health, and psychological well-being.
Additionally, the scale screens for pain intensity, stiffness, sleep quality, and overall vitality.
The scoring system is structured such that higher results indicate more pronounced symptoms and lower functional capacity, while lower scores reflect better health status.
Total scores range from 0 to 100, with higher scores indicating greater disease impact and poorer functional status.
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change from baseline at 8 weeks
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McGill-Melzack Pain Scale
Lasso di tempo: change from baseline at 8 weeks
|
To characterize the nature and intensity of the pain, the McGill-Melzack scale was utilized.
This assessment encompasses a detailed analysis of pain topography, its sensory qualities, and duration.
It also accounts for specific triggers or modifiers of pain frequency.
Scoring is interpreted such that higher cumulative values reflect more profound pain symptoms and increased clinical severity.Total scores range from 0 to 78, with higher scores indicating greater pain severity and pain-related distress
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change from baseline at 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Short Form-36 Health Survey (SF-36)
Lasso di tempo: change from baseline at 8 weeks
|
The Short Form-36 Health Survey is a comprehensive 36-item questionnaire used to assess health-related quality of life, including physical functioning, psychosocial functioning, pain, and mental health status.
Each subscale is scored on a scale ranging from 0 to 100, with higher scores indicating better functional status and improved overall health-related quality of life.
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change from baseline at 8 weeks
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Pittsburgh Sleep Quality Index
Lasso di tempo: change from baseline at 8 weeks
|
The PSQI was utilized to measure participants' self-reported sleep quality and related disturbances.
The scale comprises 19 items that form seven sub-scores, which are then aggregated into a single global score between 0 and 21.
While lower scores are indicative of better sleep quality, a cumulative score higher than five is clinically interpreted as a sign of significant sleep dysfunction.
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change from baseline at 8 weeks
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Beck Depression Inventory
Lasso di tempo: change from baseline at 8 weeks
|
To evaluate participants' depressive states, the BDI, which consists of 21 questions, was utilized.
Each item is scored between 0 and 3, and the total score is used to determine the intensity of the symptoms.
Clinical classifications were made based on the total score: 0-9 points as no depression, 10-16 points as mild, 17-23 points as moderate, and any value 24 or above as severe depression.
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change from baseline at 8 weeks
|
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International Physical Activity Questionnaire-Short Form
Lasso di tempo: change from baseline at 8 weeks
|
The International Physical Activity Questionnaire-Short Form will be used to assess participants' physical activity levels.
The questionnaire evaluates the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behavior over the last 7 days.
Total physical activity is calculated in metabolic equivalent (MET)-minutes/week.
Higher scores indicate higher levels of physical activity.
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change from baseline at 8 weeks
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Fatigue Severity Scale
Lasso di tempo: change from baseline at 8 weeks
|
To evaluate the impact of fatigue, the FSS, which views fatigue severity as a single-dimensional construct, was administered.
Participants responded to nine statements using a scoring range from 1 to 7. The overall fatigue score was derived from the average of these ratings; consequently, an increase in the total score indicates a greater level of perceived fatigue.
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change from baseline at 8 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 maggio 2022
Completamento primario (Effettivo)
6 gennaio 2023
Completamento dello studio (Effettivo)
6 maggio 2023
Date di iscrizione allo studio
Primo inviato
5 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 maggio 2026
Primo Inserito (Effettivo)
18 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IstanbulUC4
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NO
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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