NCT04568733

Brief Summary

Low cardiorespiratory fitness is related cardiovascular and total mortality. In addition, disease risk is increased with low cardiorespiratory fitness. There is strong evidence that physical activity and cardiorespiratory fitness are associated with health variables in healthy individuals. Pilates exercises, which are the subgroups of physical activity, has become popular in recent years. Current evidence suggests that Pilates training improves body composition, respiratory muscle strength, exercise performance and quality of life. In addition to these benefits, recent evidence suggests that Pilates training can improve cardiorespiratory fitness. However, there is lack of evidence on whether practicing Pilates exercises satisfy recommendations for intensity of physical activity which improves and maintains health and cardiovascular fitness. The primary aim of this study is to evaluate the cardiorespiratory responses during a Pilates training session, by measuring cardiorespiratory fitness through oxygen consumption and energy expenditure. The secondary aim of this study is to compare the cardiorespiratory responses during Pilates training session and treadmill walking at different speeds (3.2 kmh and 4.8 kmh). First, resting metabolic rate will be measured. Then, the participants will be randomized to one of the two possible experimental conditions: (1) Pilates training session than treadmill walking or (2) treadmill walking than Pilates training session. Pilates session will consist of warm-up exercises (e.g. breathing, arm circle, cat and camel spinal rotation etc.) and basic mat exercises (e.g. one leg stretching, double leg stretching, the hundred, saw, rolling like a ball, swimming, pelvic curl etc.). The Pilates session will be presented to the participants via recorded video. Participants will walk on treadmill at two different speeds: 3.2 kph (2 mph) and 4.8 kph (3 mph). Participants initially will walk at pace of 3.2 kph for 10 minutes. After 30-40 minutes- rest (after returning baseline values), participants will walk on at pace of 4.8 kph for 10 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable healthy

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

September 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

September 18, 2020

Last Update Submit

March 23, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Oxygen Consumption (VO2)

    Cardiopulmonary exercise testing system will be used to oxygen consumption (L/kg/min) assessments. Oxygen consumption is an indicator of aerobic capacity. Higher scores indicate higher aerobic capacity. The mean of oxygen consumption will be recorded for resting state, Pilates session, treadmill walking at 3.2 kph speed, and treadmill walking at 4.8 kph.

    Through basal metabolic rate assessment completion (20 minutes), through Pilates session completion (45 minutes), through treadmill walking at 3.2 kph speed completion (10 minutes), through treadmill walking at 4.8 kph speed completion (10 minutes).

  • Energy Expenditure

    A cardiopulmonary exercise testing system will be used to assess energy expenditure (kcal/min). Higher scores indicate higher energy expenditure. The mean of energy expenditure will be recorded for resting state, Pilates session, treadmill walking at 3.2 kph speed, and treadmill walking at 4.8 kph.

    Through basal metabolic rate assessment completion (20 minutes), through Pilates session completion (45 minutes), through treadmill walking at 3.2 kph speed completion (10 minutes), through treadmill walking at 4.8 kph speed completion (10 minutes).

  • Metabolic Equivalent of Task (MET)

    Metabolic Equivalent of Task (MET) defines the expression of the intensity of physical activity. 1 MET is the rate of energy expenditure while at rest, set by convention at 3.5 mL of oxygen per kilogram per minute (mL.kg.min-1). A cardiopulmonary exercise testing system will be used to assess the MET values. Higher scores indicate higher exercise intensity. The mean of MET will be recorded for resting state, Pilates session, treadmill walking at 3.2 kph speed, and treadmill walking at 4.8 kph.

    Through basal metabolic rate assessment completion (20 minutes), through Pilates session completion (45 minutes), through treadmill walking at 3.2 kph speed completion (10 minutes), through treadmill walking at 4.8 kph speed completion (10 minutes).

Secondary Outcomes (3)

  • Heart Rate

    Through basal metabolic rate assessment completion (20 minutes), through Pilates session completion (45 minutes), through treadmill walking at 3.2 kph speed completion (10 minutes), through treadmill walking at 4.8 kph speed completion (10 minutes).

  • Maximum Heart Rate (%MHR)

    Through basal metabolic rate assessment completion (20 minutes), through Pilates session completion (45 minutes), through treadmill walking at 3.2 kph speed completion (10 minutes), through treadmill walking at 4.8 kph speed completion (10 minutes).

  • The International Physical Activity Questionnaires (IPAQ) - short form

    At baseline

Study Arms (4)

Resting

NO INTERVENTION

Pilates exercise session

EXPERIMENTAL
Behavioral: Pilates exercise session

Treadmill walking at 3.2 kph

ACTIVE COMPARATOR
Behavioral: Treadmill walking at 3.2 kph

Treadmill walking at 4.8 kph

ACTIVE COMPARATOR
Behavioral: Treadmill walking at 4.8 kph

Interventions

The Pilates session will consist of warm-up exercises (e.g. breathing, arm circle, cat and camel spinal rotation etc.) and basic mat exercises (e.g. one leg stretching, double leg stretching, the hundred, saw, rolling like a ball, swimming, pelvic curl etc.). The Pilates session will be presented to the participants via pre-recorded video.

Pilates exercise session

Participants will walk on a treadmill at 3.2 kph (2 mph) speed for 10 minutes.

Treadmill walking at 3.2 kph

Participants will walk on a treadmill at 4.8 kph (2 mph) speed for 10 minutes.

Treadmill walking at 4.8 kph

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being healthy (not having any known chronic disease)
  • Volunteer to participate in the study.

You may not qualify if:

  • Pregnancy
  • Previous disorder/surgery history that can alter physical performance in walking or Pilates session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 29, 2020

Study Start

September 30, 2020

Primary Completion

December 5, 2020

Study Completion

December 5, 2020

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations