跳至主要内容
临床试验/NCT05924113
NCT05924113招募中不适用

Efficacy of Latin Dance for Promoting Wellbeing in Post Lung Transplant Recipients as Measured by Several Functional Measures, in the Outpatient Setting

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年6月12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
Mayo Clinic
入组人数
52
试验地点
1
主要终点
Change in anxiety

研究概览

简要总结

The purpose of this research study is to see if participating in Latin dance for 12 sessions can improve wellbeing in several areas including balance, fear of movement, anxiety, depression and spirometry.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Ambulatory with or without assisting devices (not on supplemental oxygen is not exclusionary), who have completed outpatient cardiopulmonary rehab and good pain control.

排除标准

  • - Tracheostomy, Hemodialysis, gastro-jejunal tubes, nasogastric tubes, wound vacs, chest tube, high levels of oxygen supplementation (mask vs nasal canula), recent falls.

研究组 & 干预措施

Post-Lung Transplant

Experimental

Subjects that received a single or double lung transplants at Mayo Clinic Florida from 1/1/2020 to the present will participate in open sessions of Latin Dance over a 12-week period.

干预措施: Latin Dance (Behavioral)

结局指标

主要结局

Change in anxiety

时间窗: Baseline, 12 weeks

Measured using the General Anxiety Disorder 7-item (GAD 7) scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.

Change in depression

时间窗: Baseline, 12 weeks

Measured using the Patient Health Questionnaire 9-item (PHQ-9) scale to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

Change in Tampa Kinesophobia Scale

时间窗: Baseline, 12 weeks

Measured using the Tampa Scale for Kinesophobia 17-item scale to assess fear of movement. Scoring is calculated by assigning scores of 1, 2, 3, and 4 to the response categories, respectively, of "strongly agree," "disagree," "agree," and "strongly agree." Total score for the seventeen items ranges from 17 to 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.

次要结局

  • Change in Forced Expiratory Volume in one second (FEV1)(Baseline, 12 weeks)
  • Change in gait(Baseline, 12 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Padro

Principal Investigator

Mayo Clinic

研究点 (1)

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