- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675162
Effect of Muscle Strengthening Training with Pilates Reformer on Overweight/obese and Normal Body Weight Women (PRET) (PRET)
The Physiological Responses of Muscle Strengthening Training with Pilates Reformer in Overweight-obese Women and Women with Normal Body Weight
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
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Trikala, Thessaly, Greece, 42100
- Department of Physical Education and Sport Science
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Trikala, Thessaly, Greece, 42100
- Department of Physical Education and Sports Science, University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Reformer Training (OW)
A group of women with overweight/obesity in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment.
|
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.
|
|
Experimental: Pilates Reformer Training (NW)
A group of women with normal weight in this arm will participate in a 60-minute muscle-strengthening training session with Pilates Reformer equipment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
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
|
At 30 minutes after the exercise session (single bout lasting 60 minutes)
|
|
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
|
At pre- and post-exercise session (single bout) at 4 minutes post-exercise
|
|
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
|
At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
|
|
Change in perceived exertion
Time Frame: At pre- and post-exercise session (single bout) at 4 minutes post-exercise.
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Rating of perceived exertion (RPE) will be measured with the Borg scale (0-10)
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At pre- and post-exercise session (single bout) at 4 minutes post-exercise.
|
|
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)
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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)
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
|
At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
|
|
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
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At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index (BMI)
Time Frame: At baseline
|
BMI will be calculated using the Quetelet's equation
|
At baseline
|
|
Waist circumference (WC)
Time Frame: At baseline
|
WC (cm) will be measured using a Gullick II tape
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At baseline
|
|
Hip circumference (HC)
Time Frame: At baseline
|
HC (cm) will be measured using a Gullick II tape
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At baseline
|
|
Waist-to-hip ratio (WHR)
Time Frame: At baseline
|
WHR will be calculated by dividing the waist by the hip measurement
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At baseline
|
|
Resting metabolic rate (RMR)
Time Frame: At baseline
|
RMR (kcal) will be measured using a portable open-circuit indirect calorimeter with a ventilated hood system
|
At baseline
|
|
Fat mass (FM)
Time Frame: At baseline
|
FM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
|
At baseline
|
|
Fat-free mass (FFM)
Time Frame: At baseline
|
FFM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
|
At baseline
|
|
Dietary intake
Time Frame: At baseline
|
Dietary intake will be assesed over a 7-day period using diet recalls
|
At baseline
|
|
Peak Maximal oxygen consumption (Peak VO2)
Time Frame: At baseline
|
Peak VO2 will be estimated by open circuit spirometry via breath by breath method
|
At baseline
|
|
Bone mass density
Time Frame: At baseline
|
Bone mass density will be measured by using Dual-emission X-ray absorptiometry
|
At baseline
|
|
Bone mass content
Time Frame: At baseline
|
Bone mass content will be measured by using Dual-emission X-ray absorptiometry
|
At baseline
|
|
Rest Heart Rate
Time Frame: At baseline
|
The rest heart rate will be estimated using a heart rate monitor
|
At baseline
|
|
Body fat (BF)
Time Frame: At baseline
|
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
|
At baseline
|
|
Body weight
Time Frame: At baseline and at 40 minutes after the exercise session.
|
Body weight will be measured on a beam balance with a stadiometer
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At baseline and at 40 minutes after the exercise session.
|
|
Body height
Time Frame: At baseline
|
Body height will be measured on a beam balance with a stadiometer
|
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)
|
Systolic Blood Pressure will be examined using a sphygmomanometer
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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)
|
Diastolic Blood Pressure will be examined using a sphygmomanometer
|
At pre-exercise, 60 minutes during PR training, and 30 minutes after the exercise session (single bout lasting 60 minutes)
|
|
Evaluation of physical activity (PA)
Time Frame: At baseline
|
The PA will be evaluated for seven days before the intervention via accelerometry
|
At baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2432/09.10.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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