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临床试验/NCT07213271
NCT07213271招募中不适用

The Impact of Dance Intervention on Metabolic Health, Gut Microbiota, Physical Fitness, and Quality of Life in Obese Breast Cancer Survivors

Comenius University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Gut Microbiota Composition (alpha and beta diversity indices)

研究概览

简要总结

The goal of this clinical trial is to evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. The main questions it aims to answer are:

Will the intervention reduce body weight, body fat, and visceral adiposity?

Will it improve cardiorespiratory fitness, motor performance, gut microbiota composition, and quality of life?

Researchers will compare women participating in the dance and nutrition program with a control group who maintain their usual lifestyle to see if the intervention leads to favorable metabolic, physical, and microbiome-related changes.

Participants will:

Attend supervised dance classes three times per week for 12 weeks.

Follow an individualized nutrition plan tailored to their resting metabolic rate.

Provide blood and stool samples, complete fitness tests, and answer quality-of-life questionnaires before and after the intervention.

详细描述

Breast cancer is one of the most prevalent cancers worldwide and its survivors frequently face long-term challenges even after successful treatment. Obesity is a well-established risk factor for both the development and recurrence of breast cancer, and it often worsens treatment-related side effects. Furthermore, increasing evidence suggests that obesity and breast cancer therapies can disrupt the gut microbiota, which may contribute to metabolic complications, systemic inflammation, impaired immunity, and reduced quality of life. Effective, non-pharmacological strategies that simultaneously target metabolic health, microbiome recovery, and physical function are needed for this growing patient population.

The present randomized controlled trial has been designed to examine whether a dance-based physical activity intervention combined with individualized nutrition can favorably influence metabolic health, gut microbiota composition, physical fitness, and quality of life in obese breast cancer survivors in remission. Dance was chosen as the primary exercise modality because it integrates aerobic, strength, and motor-coordination elements in an engaging and culturally adaptable format that may enhance adherence compared to conventional exercise programs.

A total of approximately 40 women with a history of breast cancer, currently in remission and classified as obese, will be recruited and randomized into two groups: an intervention group and a control group. The intervention group will participate in supervised dance sessions three times per week, each lasting 60 minutes, for a total of 12 weeks. Classes will be delivered by certified professional instructors and will include choreographies from folkloric, Latin American, and contemporary dance. To further support metabolic improvements, participants in this group will also receive a personalized dietary plan generated using specialized software, prescribing an energy intake of 1200-1500 kcal/day with balanced proportions of carbohydrates (30-50%), fats (25-30%), proteins (20-30%), and fiber (14 g/1000 kcal). The control group will be instructed to continue their usual daily routines and refrain from initiating new structured physical activities during the study period.

Before and after the intervention, all participants will undergo comprehensive evaluations, including:

  • Anthropometry and body composition (weight, BMI, fat mass, visceral fat, waist-hip ratio, muscle mass, resting metabolic rate) using validated bioimpedance and anthropometric methods.
  • Physical fitness testing, including a maximal cardiopulmonary exercise test on a cycle ergometer to determine VO₂max, ventilatory parameters, and workload capacity, along with motor performance assessments (handgrip strength, 30-second chair stand, and 30-second arm curl tests).
  • Biochemical analysis, including fasting glucose, insulin, lipid profile, liver enzymes, and insulin resistance index (HOMA-IR).
  • Gut permeability assessment through serum zonulin measurements.
  • Gut microbiota profiling using 16S rRNA sequencing of fecal samples, with alpha and beta diversity indices and taxonomic composition analyses.
  • Dietary intake assessed by 3-day food diaries analyzed for caloric and nutrient content.
  • Quality of life measured using the EORTC QLQ-C30 and the breast cancer-specific BR23 questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Clinical diagnosis of breast cancer disease
  • •At least one year after breast cancer treatment
  • •Must be able to swallow tablets
  • •Must be able to folow physical exercise training

排除标准

  • •Clinical diagnosis of Parkinson's disease
  • •Insulin dependent diabetes
  • •Infectious diseases within the past 2 months
  • •Use of antibiotics within the past 4 weeks before recruitment

研究组 & 干预措施

Dance

Experimental

The patients engaged in dance classes two times a week for 3 months

干预措施: Dance classes (Other)

Patients without organized physical exercise

No Intervention

The patients engaged in no structured or self-induced physical exercise or activity (sedentary individuals)

结局指标

主要结局

Gut Microbiota Composition (alpha and beta diversity indices)

时间窗: Baseline to 12 weeks

Evaluated using 16S rRNA sequencing of fecal samples; primary indices include Shannon diversity, Chao1 richness, and Bray-Curtis dissimilarity

Metabolite outcome measures

时间窗: Baseline to 12 weeks

Systemic inflammation and gut-related metabolites will be assessed by measuring blood biomarkers (hs-CRP, IL-6, TNF-α), fecal inflammatory markers (calprotectin, lactoferrin), and microbiota-derived metabolites including short-chain fatty acids (acetate, propionate, butyrate) in feces and plasma, as well as plasma metabolites such as TMAO and selected bile acids. Intestinal permeability will be evaluated through serum zonulin levels. Together, these measures will provide an integrated view of inflammatory status, microbial metabolic activity, and gut barrier function.

Quality of Life assesment

时间窗: Baseline to 12 weeks

Change in Quality of Life (EORTC QLQ-C30 Global Health Score) measured using the EORTC QLQ-C30 questionnaire (version 3.0), with scores transformed to a 0-100 scale according to the scoring manual.

次要结局

  • Cardiorespiratory Fitness(Baseline to 12 weeks)
  • Body composition(Baseline to 12 weeks)

研究者

发起方
Comenius University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viktor Bielik

professor

Comenius University

研究点 (1)

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