NCT05924113

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
55mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2023Dec 2030

Study Start

First participant enrolled

June 12, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7.6 years

First QC Date

June 20, 2023

Last Update Submit

January 3, 2026

Conditions

Lung TransplantWell-Being, Psychological

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in gait

    Baseline, 12 weeks

  • Change in Forced Expiratory Volume in one second (FEV1)

    Baseline, 12 weeks

Study Arms (1)

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.

Behavioral: Latin Dance

Interventions

Latin DanceBEHAVIORAL

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

Post-Lung Transplant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Teresa Padro, DNP, APRN

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Padro, DNP, APRN

CONTACT

(904) 477-8141Padro.Teresa@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 29, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)