- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07591766
Aerobic Dance Exercises in Fibromyalgia Syndrome
2026년 5월 15일 업데이트: 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.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (실제)
44
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Istanbul, 터키 (Türkiye)
- Istanbul University-Cerrahpaşa
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fibromyalgia Impact Scale
기간: change from baseline at 8 weeks
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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
기간: change from baseline at 8 weeks
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short Form-36 Health Survey (SF-36)
기간: change from baseline at 8 weeks
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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
기간: change from baseline at 8 weeks
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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
기간: change from baseline at 8 weeks
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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
기간: change from baseline at 8 weeks
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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
기간: change from baseline at 8 weeks
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 5월 6일
기본 완료 (실제)
2023년 1월 6일
연구 완료 (실제)
2023년 5월 6일
연구 등록 날짜
최초 제출
2026년 5월 5일
QC 기준을 충족하는 최초 제출
2026년 5월 15일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 15일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .