NCT06675162

Brief Summary

This study investigates the physiological responses and the metabolic burden of a Pilates Reformer strength training session in physically inactive premenopausal women with a body mass index of 18-24.9 and 25.01-39.9. The sample included 20 women divided into two groups: 10 with normal weight (NW) and 10 with overweight/obesity (OB). In a non-randomised control design, the participants will perform a 60-minute muscle-strengthening session with Pilates Reformer equipment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 31, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

28 days

First QC Date

October 31, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Pilates Reformer TrainingEnergy ExpenditureOxygen consumptionBlood lactateOverweightObesityBody composition

Outcome Measures

Primary Outcomes (8)

  • Change in exercise-induced energy expenditure

    Exercise energy expenditure (kcal) will be measured using a portable indirect calorimetry system

    At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)

  • Change in excess post-exercise oxygen consumption (EPOC)

    EPOC (kcal) will be measured using a portable indirect calorimetry system

    At 30 minutes after the exercise session (single bout lasting 60 minutes)

  • Change in blood lactate concentration (BLa)

    BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits

    At pre- and post-exercise session (single bout) at 4 minutes post-exercise

  • Change in heart rate

    Heart rate (bpm) will be measured with a wearable heart rate monitor

    At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)

  • Change in perceived exertion

    Rating of perceived exertion (RPE) will be measured with the Borg scale (0-10)

    At pre- and post-exercise session (single bout) at 4 minutes post-exercise.

  • Respiratory Exchange Ratio (RER)

    Respiratory Exchange Ratio (RER) will be measured using a portable indirect calorimetry system

    At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)

  • Breath Frequency (BF)

    Breath Frequency (BF) will be measured using a portable indirect calorimetry system

    At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)

  • Change in oxygen consumption

    Oxygen consumption will be measured using a portable indirect calorimetry system

    At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)

Secondary Outcomes (18)

  • Body weight

    At baseline and at 40 minutes after the exercise session.

  • Body height

    At baseline

  • Body mass index (BMI)

    At baseline

  • Waist circumference (WC)

    At baseline

  • Hip circumference (HC)

    At baseline

  • +13 more secondary outcomes

Study Arms (2)

Pilates Reformer Training (OW)

EXPERIMENTAL

A group of women with overweight/obesity in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment.

Other: Pilates Reformer Training

Pilates Reformer Training (NW)

EXPERIMENTAL

A group of women with normal weight in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment.

Other: Pilates Reformer Training

Interventions

Participants will perform a 60-minute Pilates Reformer muscle-strengthening session. The training will include a 7-10 minute warm-up, 35 minutes of muscle strengthening and mobility exercises and a 5-minute recovery. During the training, the physiological responses and the energy expenditure of the participants will be recorded.

Pilates Reformer Training (NW)Pilates Reformer Training (OW)

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be approved for participation by an orthopedist and internist
  • Have not followed any diet or nutritional supplements for weight loss in the last six months before the study
  • The group with overweight/obesity will consist of women with a body mass index of 25.01 - 39.9 kg/m2
  • Be physically Inactive in the last six months before the study.

You may not qualify if:

  • Musculoskeletal injury
  • Weight loss\>10% in 6 months
  • \<20 years
  • \>50 years
  • Μenopause
  • Chronic diseases
  • Use of alcohol, caffeine and any type of ergogenic supplements or medication during the study
  • Physically active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Physical Education and Sport Science

Trikala, Thessaly, 42100, Greece

Location

Department of Physical Education and Sports Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 5, 2024

Study Start

November 4, 2024

Primary Completion

December 2, 2024

Study Completion

January 7, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations