Physiological ResponsesPRETNCT06675162
Effect of Muscle Strengthening Training with Pilates Reformer on Overweight/obese and Normal Body Weight Women (PRET)
A study testing Pilates Reformer Training in people with Physiological Responses and Pilates Exercise, run by University of Thessaly at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Responses, Pilates Exercise, Overweight and Obese Women
- What is being tested?
- Pilates Reformer Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGreece
- Study dates
- 4 Nov 2024to 7 Jan 2025
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of Physical Education and Sport Science
Trikala, Thessaly, 42100
Department of Physical Education and Sports Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Official title: The Physiological Responses of Muscle Strengthening Training with Pilates Reformer in Overweight-obese Women and Women with Normal Body Weight
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.
Read the detailed description
Pilates Reformer (PR) is one of the most popular types of exercise worldwide and is considered a gentle and safe method for untrained and overweight people. The PR training approach has been found to contribute positively to various health conditions (vascular function, blood pressure, physical fitness, musculoskeletal problems), improving the quality of life and mental well-being of the participants. At the same time, it seems that it can have a positive effect on the lipid profile and other biochemical markers such as insulin and fasting glucose. Furthermore, muscle strengthening training with PR equipment provides better levels of mobility, increasing active range of motion, and also provides greater pelvic and trunk stability for both adult and middle-aged participants.
This study is designed to investigate the physiological and metabolic burden of a muscle-strengthening session with PR equipment in 20 pre-menopausal and physically inactive women with a body mass index (BMI) of 18-24, 99 \& 25.01-39.9, as well as to determine the contribution of energy systems (mitochondrial, glycolytic) during and after the exercise. Each training session will last approximately 60 minutes, will be led by at least one trainer, and will include a warm-up of 7-10 minutes, muscle strengthening and mobility exercises of 35 minutes, and a recovery of 5 minutes. Anthropometric indicators, dietary intake, resting heart rate, blood lactate, resting metabolic rate, muscle soreness, rate of perceived exertion, blood pressure, and performance measurements will be measured at baseline. The metabolic cost during PR training session will be estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer. After the PR training session will be measured the rate of perceived exertion, blood pressure, blood lactate, and muscle soreness levels.
- Conditions
- Physiological Responses, Pilates Exercise, Overweight and Obese Women, Energy Expenditure, Strength Training
- Being tested
- Pilates Reformer Training
- Keywords
- Pilates Reformer Training, Energy Expenditure, Oxygen consumption, Blood lactate, Overweight, Obesity, Body composition
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Reformer TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pilates Reformer Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise-induced energy expenditure
Exercise energy expenditure (kcal) will be measured using a portable indirect calorimetry system
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Body weight will be measured on a beam balance with a stadiometer
Measured: At baseline and at 40 minutes after the exercise session.
Body height
Body height will be measured on a beam balance with a stadiometer
Measured: At baseline
Body mass index (BMI)
BMI will be calculated using the Quetelet's equation
Measured: At baseline
Waist circumference (WC)
WC (cm) will be measured using a Gullick II tape
Measured: At baseline
Hip circumference (HC)
HC (cm) will be measured using a Gullick II tape
Measured: At baseline
Waist-to-hip ratio (WHR)
WHR will be calculated by dividing the waist by the hip measurement
Measured: At baseline
Resting metabolic rate (RMR)
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
Measured: At baseline
Body fat (BF)
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline
Fat mass (FM)
FM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline
Fat-free mass (FFM)
FFM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
Measured: At baseline
Bone mass density
Bone mass density will be measured by using Dual-emission X-ray absorptiometry
Measured: At baseline
Bone mass content
Bone mass content will be measured by using Dual-emission X-ray absorptiometry
Measured: At baseline
Peak Maximal oxygen consumption (Peak VO2)
Peak VO2 will be estimated by open circuit spirometry via breath by breath method
Measured: At baseline
Dietary intake
Dietary intake will be assesed over a 7-day period using diet recalls
Measured: At baseline
Systolic Blood Pressure
Systolic Blood Pressure will be examined using a sphygmomanometer
Measured: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Diastolic Blood Pressure
Diastolic Blood Pressure will be examined using a sphygmomanometer
Measured: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Rest Heart Rate
The rest heart rate will be estimated using a heart rate monitor
Measured: At baseline
Evaluation of physical activity (PA)
The PA will be evaluated for seven days before the intervention via accelerometry
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 posted5 Nov 2024
- Study start4 Nov 2024
- Primary completion2 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological ResponsesStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syrou Niki, RN,MPH, PhD, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675162
- Sponsor's protocol ID
- 2432/09.10.2024
- Acronym
- PRET
- Status last verified
- Jan 2025
- First submitted
- 31 Oct 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Responses of Muscle Strengthening Training with Pilates Reformer in Overweight-obese Women and Women with Normal Body Weight
- ClinicalTrials.gov ID
- NCT06675162
- Acronym / sponsor ID
- PRET / 2432/09.10.2024
- Conditions
- Physiological Responses, Pilates Exercise, Overweight and Obese Women, Energy Expenditure, Strength Training
- Keywords
- Pilates Reformer Training, Energy Expenditure, Oxygen consumption, Blood lactate, Overweight, Obesity, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 5 Nov 2024 (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.
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.
Detailed description
Pilates Reformer (PR) is one of the most popular types of exercise worldwide and is considered a gentle and safe method for untrained and overweight people. The PR training approach has been found to contribute positively to various health conditions (vascular function, blood pressure, physical fitness, musculoskeletal problems), improving the quality of life and mental well-being of the participants. At the same time, it seems that it can have a positive effect on the lipid profile and other biochemical markers such as insulin and fasting glucose. Furthermore, muscle strengthening training with PR equipment provides better levels of mobility, increasing active range of motion, and also provides greater pelvic and trunk stability for both adult and middle-aged participants.
This study is designed to investigate the physiological and metabolic burden of a muscle-strengthening session with PR equipment in 20 pre-menopausal and physically inactive women with a body mass index (BMI) of 18-24, 99 \& 25.01-39.9, as well as to determine the contribution of energy systems (mitochondrial, glycolytic) during and after the exercise. Each training session will last approximately 60 minutes, will be led by at least one trainer, and will include a warm-up of 7-10 minutes, muscle strengthening and mobility exercises of 35 minutes, and a recovery of 5 minutes. Anthropometric indicators, dietary intake, resting heart rate, blood lactate, resting metabolic rate, muscle soreness, rate of perceived exertion, blood pressure, and performance measurements will be measured at baseline. The metabolic cost during PR training session will be estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer. After the PR training session will be measured the rate of perceived exertion, blood pressure, blood lactate, and muscle soreness levels.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Reformer Training (OW) | Experimental | Other: Pilates Reformer TrainingA group of women with overweight/obesity in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment. |
| Pilates Reformer Training (NW) | Experimental | Other: Pilates Reformer TrainingA group of women with normal weight in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Musculoskeletal injury
- Weight loss>10% in 6 months
- <20 years
- >50 years
- Μenopause
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 Reformer TrainingParticipants 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. | Other | Pilates Reformer Training (NW), Pilates Reformer Training (OW) |
Primary outcome
Change in exercise-induced energy expenditure
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Exercise energy expenditure (kcal) will be measured using a portable indirect calorimetry system
Change in excess post-exercise oxygen consumption (EPOC)
Time frame: At 30 minutes after the exercise session (single bout lasting 60 minutes)
EPOC (kcal) will be measured using a portable indirect calorimetry system
Change in blood lactate concentration (BLa)
Time frame: At pre- and post-exercise session (single bout) at 4 minutes post-exercise
BLa (mmol/L) concentration will be measured in a microphotometer with commercially available kits
Change in heart rate
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Heart rate (bpm) will be measured with a wearable heart rate monitor
Change in perceived exertion
Time frame: At pre- and post-exercise session (single bout) at 4 minutes post-exercise.
Rating of perceived exertion (RPE) will be measured with the Borg scale (0-10)
Respiratory Exchange Ratio (RER)
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Respiratory Exchange Ratio (RER) will be measured using a portable indirect calorimetry system
Breath Frequency (BF)
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Breath Frequency (BF) will be measured using a portable indirect calorimetry system
Change in oxygen consumption
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Oxygen consumption will be measured using a portable indirect calorimetry system
18 secondary outcomes
Body weight
Time frame: At baseline and at 40 minutes after the exercise session.
Body height
Time frame: At baseline
Body mass index (BMI)
Time frame: At baseline
Waist circumference (WC)
Time frame: At baseline
Hip circumference (HC)
Time frame: At baseline
Waist-to-hip ratio (WHR)
Time frame: At baseline
Resting metabolic rate (RMR)
Time frame: At baseline
Body fat (BF)
Time frame: At baseline
Fat mass (FM)
Time frame: At baseline
Fat-free mass (FFM)
Time frame: At baseline
Bone mass density
Time frame: At baseline
Bone mass content
Time frame: At baseline
Peak Maximal oxygen consumption (Peak VO2)
Time frame: At baseline
Dietary intake
Time frame: At baseline
Systolic Blood Pressure
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Diastolic Blood Pressure
Time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
Rest Heart Rate
Time frame: At baseline
Evaluation of physical activity (PA)
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 10 Jan 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Reformer Training in people with Physiological Responses and Pilates Exercise, run by University of Thessaly at 2 sites in Greece.
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 4 inclusion and 8 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Change in exercise-induced energy expenditure (time frame: At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)). The study lists 8 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 10 Jan 2025.