NCT07107061

Brief Summary

Pilates exercises have been shown to be effective for a range of outcomes; however, it is unclear whether they can effectively contribute to fat mass reduction, especially when compared with a technique known to be effective for this purpose, such as aerobic training. Furthermore, Pilates' potential for increasing lean mass also requires further investigation. The aim of this study was to assess the effectiveness of Pilates compared with aerobic training, as well as the combination of these activities, on body composition in young adults. Eighty women aged 18 to 40 years were randomized to four groups: Pilates (n = 20), aerobic (n = 20), Pilates plus aerobic (n = 20), and control (n = 20). Body composition was assessed by dual-energy X-ray absorptiometry (DXA), considering: total fat mass (kg), percentage of total fat mass (%), total lean mass (kg), and total lean mass adjusted for height (kg/m²). Additionally, total body mass (kg) and body mass index (BMI) (kg/m2) values were considered. The interventions were carried out for 12 weeks, three times a week, lasting 60 minutes/session. Analyses were performed by intention-to-treat and per protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

July 30, 2025

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Percentage of total body fat mass (%)

    Percentage of total body fat mass assessed by dual-energy X-ray absorptiometry (DXA)

    Baseline and after 12 weeks

  • Total lean mass (kg)

    Absolute total body lean mass assessed by dual-energy X-ray absorptiometry (DXA)

    Baseline and after 12 weeks

  • Total fat mass (Kg)

    Absolute total body fat mass assessed by dual-energy X-ray absorptiometry (DXA)

    Baseline and after 12 weeks

  • Total lean mass adjusted for height (kg/m²)

    Total lean mass adjusted for height assessed by dual-energy X-ray absorptiometry (DXA)

    Baseline and after 12 weeks

Secondary Outcomes (8)

  • Trunk fat mass (kg)

    Baseline and after 12 weeks

  • Upper limb fat mass (kg)

    Baseline and after 12 weeks

  • Lower limb fat mass (kg)

    Baseline and after 12 weeks

  • Trunk lean mass (kg)

    Baseline and after 12 weeks

  • Upper limb lean mass (kg)

    Baseline and after 12 weeks

  • +3 more secondary outcomes

Study Arms (4)

Pilates

EXPERIMENTAL

A total of 13 exercises were selected for the Pilates group, including two stretching exercises and 11 strengthening exercises for the main muscle groups. Mat exercises and equipment exercises (Ladder Barrel, Cadillac, Step Chair, Reformer, Springboard, and Small Barrel) will be used. Two protocols will be adopted for progression (protocol 1: weeks 1-6; protocol 2: weeks 7-12). Two sets of 10 repetitions will be performed, with a 30-second rest between sets and exercises. The two-by-two rule will be used to increase the load. In this case, the load will increase when the participant performs ≥ 2 repetitions above their target of 10 repetitions in the last set, in two consecutive training sessions. The interventions will last 12 weeks, three times a week, for 60 minutes.

Other: Pilates exercises

Aerobic

EXPERIMENTAL

The aerobic group will perform walking/running exercises on a treadmill using the extensive interval training method. To define the intensity and periodization of the training, the running speed associated with V̇O2max (vV̇O2max), second ventilatory threshold (vLV2), and average speed between vV̇O2max and vLV2 (v50%Δ) will be used as reference. These parameters will be obtained from a maximal exercise test on a treadmill, performed before the start of the interventions. Two protocols will be adopted, with adjustments in density (work-to-recovery ratio) every two weeks. The interventions will last 12 weeks, three times a week, for 60 minutes.

Other: Aerobic exercise

Pilates plus aerobic

EXPERIMENTAL

They will perform the same exercises as the Pilates group, however, with 1 set of 10 repetitions, with a 30-second rest between sets and exercises, totaling 30 minutes of intervention per session. In the second half of the intervention period, aerobic exercises will be performed, identical to those of the aerobic group, but for 30 minutes. The interventions will last 12 weeks, three times a week, for 60 minutes.

Other: Pilates exercises plus aerobic exercise

Control

NO INTERVENTION

This group will be instructed to maintain their usual routine.

Interventions

Aerobic exercises are characterized as a modality that works cardiorespiratory fitness.

Also known as: aerobic
Aerobic

Pilates exercises are characterized as muscle strengthening and stretching, while aerobic exercises are characterized as a modality that works cardiorespiratory fitness.

Also known as: Pilates, aeróbio
Pilates plus aerobic

Pilates exercises are characterized as muscle strengthening and stretching.

Also known as: Pilates
Pilates

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female;
  • Age between 18 and 40 years;
  • Not having exercised in the last 6 months;
  • Agreeing not to perform any other type of exercise during the study period;
  • Being fit to exercise according to the Physical Activity Readiness Questionnaire (PAR-Q) criteria;
  • Not having musculoskeletal or neurological disorders that could affect exercise performance;
  • Not having known cardiovascular or respiratory diseases;
  • Not having cognitive impairment that leads to the inability to follow simple commands;
  • Not being a smoker;
  • Not being pregnant;
  • Not being on any specific diets.

You may not qualify if:

  • Refusing to sign the informed consent form;
  • Unable to complete the pre-intervention assessment procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400-000, Brazil

Location

MeSH Terms

Interventions

ExerciseExercise Movement Techniques

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researcher responsible for randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

August 10, 2025

Primary Completion

December 10, 2025

Study Completion

December 10, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data will be provided as supplementary material when the study results are published.

Shared Documents
SAP
Time Frame
Between 09/01/2025 until the date of publication of the study.
Access Criteria
The information will be freely accessible.

Locations