NCT05867498

Brief Summary

Concurrent and aerobic physical exercise are recognized strategies for the treatment of overweight and obesity. The interventions of these modalities have been performed with cardiovascular machines or guided execution in their majority, making it possible to improve the health of this population; however, the studies have used high-cost equipment that is not very accessible to the general population. For this reason, we propose to compare the effects of two 12-week programs: concurrent vs. aerobic, using an innovative methodology with musicalized and outdoor activities, little approached by research. The polarized training intensity distribution model, usually used in sports and now applied to physical activity to improve VO2max, muscular strength, and body composition, will be used to determine which intervention is superior in improving these variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

April 17, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

May 2, 2023

Last Update Submit

October 31, 2023

Conditions

Keywords

ObesityConcurrent exerciseCombined trainingCircuit-Based ExerciseCardiorespiratory fitnessMuscle StrengthBody Composition

Outcome Measures

Primary Outcomes (1)

  • Change in maximal oxygen consumption

    A graded exercise test on a cycle ergometer (ERGO-FIT, Germany) will obtain maximal oxygen consumption (VO2max) using a METAMAX 3B gas analyzer (CORTEX, Germany). VO2max will be reported in ml/kg/min.

    Baseline and 12-weeks

Secondary Outcomes (8)

  • Change in mean propulsive velocity

    Baseline and 12-weeks

  • Change in maximum velocity

    Baseline and 12-weeks

  • Change in peak maximum power

    Baseline and 12-weeks

  • Change in body fat

    Baseline and 12-weeks

  • Change in muscle mass

    Baseline and 12-weeks

  • +3 more secondary outcomes

Study Arms (2)

Concurrent exercise

EXPERIMENTAL

Strength component (circuit-based exercise) 7 exercises: * General (2 sets of 15-18 Rep, OMNI-Resistance Exercise Scale 4-5, x 10 s) 180 s * Block (3 sets of 12-15 Rep, OMNI-Resistance Exercise Scale 5-6, x 10 s) 70 s * Concentrated (3 sets of 10-12 Rep, OMNI-Resistance Exercise Scale 7-8, x 15 s) 110 s Aerobic component * Low-to-moderate-intensity continuous training: 16 min to 18 min (\< VT 1) * Interval training: in a block (\> VT 2) * 5 bouts of 30 s loads. Work:rest ratio: 1:1 * 4 bouts of 45 s loads. Work:rest ratio: 1:1 * 5 bouts of 50 s loads. Work:rest ratio: 2:1 * 4 bouts of 60 s loads. Work:rest ratio: 2:1 * 3 bouts of 70 s loads. Work:rest ratio: 2:1 * 4 bouts of 80 s loads. Work:rest ratio: 2:1

Behavioral: Concurrent exercise

Aerobic exercise

ACTIVE COMPARATOR

* Low-to-moderate-intensity continuous training: 36 min (\< VT 1) * Interval training: in two blocks (\> VT 2) 5 bouts of 35 s loads. Work:rest ratio: 1:1 4 bouts of 45 s loads. Work:rest ratio: 1:1 4 bouts of 60 s loads. Work:rest ratio: 2:1 3 bouts of 75 s loads. Work:rest ratio: 2:1 4 bouts of 80 s loads. Work:rest ratio: 2:1

Behavioral: Aerobic exercise

Interventions

Strength component (circuit-based exercise) and aerobic component (based on musicalized and outdoor activities).

Concurrent exercise

Low-to-moderate-intensity continuous training and interval training based on musicalized and outdoor activities.

Aerobic exercise

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 59 years old.
  • BMI \>25.0.
  • Waist circumference ≥85cm in women, and ≥94cm in men.
  • Individuals participating voluntarily.

You may not qualify if:

  • History of cardiovascular and pulmonary disease.
  • Uncontrolled psychiatric problems.
  • People under treatment with anticoagulants, beta-blockers, calcium antagonists, and bronchodilators.
  • Having osteo-muscular problems that may affect participation in exercise sessions.
  • Pregnant women.
  • People with a nutritional plan for weight loss.
  • Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, 50010, Colombia

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Víctor Hugo Arboleda-Serna

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 22, 2023

Study Start

April 17, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations