NCT06903455

Brief Summary

The objective of this study is to analyze a culturally relevant cardiovascular dance-based intervention called Fitfolk in overweight or obese Mapuche women from a rural community in Padre las Casas. Participants will be randomly assigned to two groups: an experimental group that will receive a culturally relevant cardiovascular dance program (EG, n=11), and a control group that will receive a conventional physical exercise program (CG, n=11). Both groups will be trained at a community center in the same rural area, led by a physical education professional. The principle of training progression will be followed, and they will exercise three times per week with sessions of approximately one hour for 12 weeks. Physical health parameters, quality of life, motivation, and barriers to physical exercise will be assessed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

March 24, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

overweight, obesity, non-communicable diseases, exercise

Outcome Measures

Primary Outcomes (3)

  • Improvement in the physical condition of the participants related to the intervention, according to the ST3x1 step test

    Its best measurement is maximum oxygen consumption, which will be measured using the ST3x1 step test. assessed as relative vo2max (mL/kg/min), where higher values indicate improvements in cardiorespiratory fitness.

    from the start of treatment until its completion at 12 weeks

  • Improvements in participants' physical strength related to the intervention

    Physical strength will be assessed using the 5-times sit-to-stand test and handgrip dynamometry. A decrease in the time spent sitting and standing 5 times and an increase in hand grip in kilograms will indicate an increase in physical strength.

    From the start of treatment to its completion at 12 weeks

  • Improvement in participants' long-term glycemic control relative to the intervention, as measured by glycated hemoglobin assay

    This variable will be measured by a blood test that measures the average blood glucose level over the last two or three months, the result is presented as a percentage.

    from the start of treatment until its completion at 12 weeks

Secondary Outcomes (4)

  • Improvement in participants' quality of life in relation to the intervention, according to the WHOQOL-BREF quality of life questionnaire

    from the start of treatment until its completion at 12 weeks

  • Improvement in participants' physical activity compared to the intervention, according to the International Physical Activity Questionnaire (IPAQ).

    from the start of treatment until its completion at 12 weeks

  • Improvement in participants' motivation to engage in physical activity relative to the intervention, according to the "BREQ-3" exercise behavior regulation questionnaire.

    from the start of treatment until its completion at 12 weeks

  • Improvements in perceived barriers and benefits to physical exercise among participants in relation to the intervention, according to the Exercise Benefits and Barriers Scale (EBBS).

    from the start of treatment until its completion at 12 weekS

Study Arms (2)

culturally relevant cardio dance called Fitfolk

EXPERIMENTAL

"Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore.

Other: Fit-folk cardio dance

conventional physical exercise

ACTIVE COMPARATOR

physical exercise program that contains resistance exercise and cardiorespiratory training

Other: Conventional physical exercise

Interventions

"Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore.

culturally relevant cardio dance called Fitfolk

conventional physical exercise program that uses resistance exercise and cardiorespiratory training

conventional physical exercise

Eligibility Criteria

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

You may qualify if:

  • Women ≥18 years old,
  • Belonging to the Huichacura-Cayuqueo indigenous community.
  • Sedentary, according to WHO criteria.
  • Diagnosed with malnutrition due to excess (overweight/obesity).
  • With controlled chronic diseases (diabetes, hypertension, dyslipidemia).

You may not qualify if:

  • Those with organic pathologies that make it impossible to engage in physical activity, such as stroke, myocardial infarction, neurological diseases, or uncontrolled chronic diseases, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comunidad indigena Huichacura Cayuqueo

Padre Las Casas, Región de la Araucanía, 4850000, Chile

Location

MeSH Terms

Conditions

OverweightObesityNoncommunicable DiseasesMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

December 16, 2024

Primary Completion

March 6, 2025

Study Completion

June 15, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations