HealthyNCT04568733
Cardiorespiratory Responses to a Pilates Training Session and Treadmill Walking in Healthy Adults
A study testing Pilates exercise session, Treadmill walking at 3.2 kph and Treadmill walking at 4.8 kph in people with Healthy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pilates exercise session, Treadmill walking at 3.2 kph and Treadmill walking at 4.8 kph
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2020to 5 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy (not having any known chronic disease)
- Volunteer to participate in the study.
Who cannot join
- Pregnancy
- Previous disorder/surgery history that can alter physical performance in walking or Pilates session.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cardiorespiratory System Responses During Pilates Exercises and Walking
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.
- Conditions
- Healthy
- Being tested
- Pilates exercise session, Treadmill walking at 3.2 kph, Treadmill walking at 4.8 kph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercise sessionBehavioural
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.
Treadmill walking at 3.2 kphBehavioural
Participants will walk on a treadmill at 3.2 kph (2 mph) speed for 10 minutes.
Treadmill walking at 4.8 kphBehavioural
Participants will walk on a treadmill at 4.8 kph (2 mph) speed for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Resting | No intervention | Not described |
| Pilates exercise session | Experimental | Not described Receives: Behavioral: Pilates exercise session |
| Treadmill walking at 3.2 kph | Active comparator | Not described Receives: Behavioral: Treadmill walking at 3.2 kph |
| Treadmill walking at 4.8 kph | Active comparator | Not described Receives: Behavioral: Treadmill walking at 4.8 kph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Heart rate (beats.min-1) will be assessed using a heart rate monitor. The chest strap will be secured to participants against their skin below the sternum. Higher scores indicate higher heart rate. The mean of heart rate will be recorded for resting state, Pilates session, treadmill walking at 3.2 kph speed, and treadmill walking at 4.8 kph.
Measured: 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)
Maximum Heart Rate (%MHR) will be assessed using a heart rate monitor. Heart rate data will be multiplied by 100 and divided by the predicted maximum heart rate to determine the percentage of maximum predicted heart rate (%MHR) achieved by each individual. Higher scores indicate higher exercise intensity. The mean of %MHR will be recorded for resting state, Pilates session, treadmill walking at 3.2 kph speed, and treadmill walking at 4.8 kph.
Measured: 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
The International Physical Activity Questionnaires (IPAQ) - short form will be used to inquire about the physical activity levels of the participants. This questionnaire consists of seven questions asking participants to remind the last week's physical activity. The IPAQ-short form inquiries about the number of days and amount of the spent walking, sitting or participating in moderate (e.g., bicycling at a regular pace) and vigorous-intensity activities (e.g., fast bicycling, digging) and reports the frequency and duration of these activity. Higher scores indicate higher levels of physical activity.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start30 Sep 2020
- Primary completion5 Dec 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568733
- Sponsor's protocol ID
- 2020-GOKAE-0133
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiorespiratory System Responses During Pilates Exercises and Walking
- ClinicalTrials.gov ID
- NCT04568733
- Acronym / sponsor ID
- 2020-GOKAE-0133
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being healthy (not having any known chronic disease)
- Volunteer to participate in the study.
Key exclusion criteria (2 listed)
- Pregnancy
- Previous disorder/surgery history that can alter physical performance in walking or Pilates session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercise sessionThe 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. | Behavioural | Pilates exercise session |
| Treadmill walking at 3.2 kphParticipants will walk on a treadmill at 3.2 kph (2 mph) speed for 10 minutes. | Behavioural | Treadmill walking at 3.2 kph |
| Treadmill walking at 4.8 kphParticipants will walk on a treadmill at 4.8 kph (2 mph) speed for 10 minutes. | Behavioural | Treadmill walking at 4.8 kph |
Primary outcome
Oxygen Consumption (VO2)
Time frame: 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).
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.
Energy Expenditure
Time frame: 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).
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.
Metabolic Equivalent of Task (MET)
Time frame: 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) 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.
3 secondary outcomes
Heart Rate
Time frame: 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)
Time frame: 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
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise session, Treadmill walking at 3.2 kph and Treadmill walking at 4.8 kph in people with Healthy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Consumption (VO2) (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.