A Study of Latin Dance for Post- Lung Transplant

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05924113
Collaborator
(none)
52
1
1
15
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Latin Dance
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Latin Dance for Promoting Wellbeing in Post Lung Transplant Recipients as Measured by Several Functional Measures, in the Outpatient Setting
Actual Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Jun 12, 2024
Anticipated Study Completion Date :
Sep 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post-Lung Transplant

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.

Behavioral: Latin Dance
Latin dance sessions that include a warm-up routine with music, two choreographed dances, and a cooldown routine with music.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Florida Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Teresa Padro, DNP, APRN, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Teresa Padro, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05924113
Other Study ID Numbers:
  • 23-001508
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 29, 2023