Well-Being, Psychological Clinical Trial
Official title:
Efficacy of Latin Dance for Promoting Wellbeing in Post Lung Transplant Recipients as Measured by Several Functional Measures, in the Outpatient Setting
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.
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | September 12, 2024 |
| Est. primary completion date | June 12, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. Exclusion Criteria: - Tracheostomy, Hemodialysis, gastro-jejunal tubes, nasogastric tubes, wound vacs, chest tube, high levels of oxygen supplementation (mask vs nasal canula), recent falls. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in anxiety | 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. | Baseline, 12 weeks | |
| Primary | Change in depression | 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. | Baseline, 12 weeks | |
| Primary | Change in Tampa Kinesophobia Scale | 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. | Baseline, 12 weeks | |
| Secondary | Change in gait | 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. | Baseline, 12 weeks | |
| Secondary | Change in Forced Expiratory Volume in one second (FEV1) | Measured by spirometry to determine the volume of air (in liters) exhaled in the first second during forced exhalation | Baseline, 12 weeks |