A Study of Latin Dance for Post- Lung Transplant

Not Applicable

Recruiting

• Conditions: Well-Being, Psychological; Lung Transplant
• Interventions: Behavioral: Latin Dance

• Registration Number: NCT05924113
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-06-12
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2024-12-12
• Study Completion: 2025-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-Lung Transplant	Latin Dance	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.

Primary Outcome Measures

Name	Time	Method
Change in anxiety	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in one second (FEV1)	Baseline, 12 weeks	Measured by spirometry to determine the volume of air (in liters) exhaled in the first second during forced exhalation
Change in gait	Baseline, 12 weeks	Measured using the Dynamic Gait Index 8-item scale to assess the likelihood of falling. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "severe impairment," "moderate impairment," "mild impairment," and "normal". Total score for the eight items ranges from 0 to 24 where 0 is the lowest level of function and 24 is the highest level of function.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States