ObesityFitNutrBC-12NCT06584578
Exercise Nutrition and Body Composition
A study testing Whole-Body Electromyostimulation, Pilates and Tai Chi in people with Obesity and Overweight, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition The purpose of the study was to examine the effect of 12 weeks of different exercise training modalities and nutritional guidance on body composition.This study was conducted voluntarily by individuals who applied… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Whole-Body Electromyostimulation, Pilates and Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 31 Mar 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being healthy
- Willing to maintain the intervention for 12 weeks
Who cannot join
- Being under 18 years old
- Having a chronic disease
- Medication that relevantly affect muscle metabolism
- Contraindication for Bio Impedance Analysis
- Contraindication for Whole Body Electromyostimulation
- Contraindications for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition
Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition
The purpose of the study was to examine the effect of 12 weeks of different exercise training modalities and nutritional guidance on body composition.This study was conducted voluntarily by individuals who applied to a private health center in the Safranbolu district of Karabük and received medical nutrition treatment. It was conducted on four groups as Pilates, Yoga, WB-EMS and control and lasted 12 weeks in total. The training period of the participants in the group other than the control group was 2 days a week and 45 minutes per day, and 3 exercises consisted of warm-up, main part and cool-down parts. Some body composition assessments were made to the participants before and after their 12-week exercises. Body composition measurements (height, body weight, body mass index, body fat and muscle percentage) and systolic and diastolic blood pressure measurements were taken. Maximum heart rate (HRmax) (beats/min), average HR (beats/min), total calories burned (kcal) were determined to determine and monitor the load and intensity of each exercise for 12 weeks, and the Borg Scale was applied to the participants after each exercise to determine the degree of difficulty they perceived from the exercise they did and to evaluate their enjoyment of the exercises. Also, A personalized nutrition program prepared by a specialist dietitian for 12 weeks.
Read the detailed description
Height and Body Composition Measurements: Height measurements of the athletes participating in the study were made with a height scale with a precision of 0.01 mm. Body weight and body mass index measurements were determined with an INBODY 120 brand body fat analyzer.
Warm-up Protocol: participants performed the same warm-up protocol in all conditions, a general warm-up consisting of 10 min of full-body light stretching exercises (do Carmo et al. 2021).
Determination of Exercise Load and Intensity: In order to determine and follow the load and intensity of each exercise for 6 weeks, a Realtrack Seego brand pulse monitoring system (Spain) was used, which instantly records the maximum heart rate (HRmax) (beats/min), average HR (beats/min), and total calories burned (kcal) values, and the values were recorded by the researcher by watching them on the monitor.
Yoga Exercise Program: Each yoga session lasts 1.5 hours. The emphasis in yoga classes is on asana practice; all types of poses are included, including sitting, standing, balancing poses, kneeling, forward and backward bending, supine and prone positions and inversions. Classes always begin with a short body and breath scan and end with an 8-10 minute relaxation practice in Savasana (lying corpse pose). The scenarios for the sessions are prepared according to two valuable yoga books (Satyananda, 2002). Yoga trainings are performed by an expert trainer.
Pilates Exercise Program: The Pilates exercise program complied with the recommended amount of exercise for improving the health of the elderly, and the movements suitable for the elderly were selected from the work of Cathleen Murakami (Murakami, 2006). The Pilates exercise program included a five-minute warm-up exercise, and the order was as follows: breathing, 2 repetitions (repetitions); compression and release, 2 repetitions × 2 sets; supine spine, 2 repetitions × 2 sets; arm circles, 4 repetitions × 2 sets; knee-to-knee bending stretch, 2 repetitions × 2 sets; pelvic peel and hinge, 2 repetitions × 2 sets; arms crossed spine, 2 repetitions × 2 sets; and seated hip stretch, 2 repetitions. The main exercise was performed for 30 minutes in the following order: swim, 10 repetitions × 1 set; rolling and rolling, 3 repetitions × 2 sets; single leg circle, 5 repetitions × 2 sets. The cool-down exercise was performed in the same way as the warm-up exercise (Herman, 2008). Pilates training was performed by an expert trainer.
Nutritional Guidance: A personalized nutrition program was prepared for each participant by a dietician in a face-to-face meeting based on the individual's body analysis values (body fat, muscle mass, body water ratios), complete blood count results, lifestyle and eating habits, with daily calorie intake not below the Basal Metabolic Rate (BMR) and a protein value of at least 1.5 g/kg.
- Conditions
- Obesity, Overweight, Weight Loss, Muscle Maintenance
- Being tested
- Whole-Body Electromyostimulation, Pilates, Tai Chi, Nutritional counseling
- Keywords
- Exercise, WB-EMS, Pilates, Yoga, Nutritional Guidance, Body Composition
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body ElectromyostimulationOther
Also called Whole-Body Electromyostimulation exercise, Pilates exercise, Tai Chi exercise
Participants were included in tree exercise programs (Yoga, Pilates, WB-EMS) by an expert trainer 2 days a week for 12 weeks. At the same time, an active control group conducted a weekly diet counseling for 12 weeks by an expert dietician.
PilatesOther
Pilates exercise twice weekly for 12 weeks
Tai ChiOther
Pilates exercise twice weekly for 12 weeks
Nutritional counselingOther
Nutritional counseling for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Electomyostimulation (WB-EMS) | Experimental | Whole-Body Electromyostimulation Receives: Other: Whole-Body Electromyostimulation |
| Pilates | Experimental | Pilates Receives: Other: Pilates |
| Tai Chi | Experimental | Tai-Chi exercise Receives: Other: Tai Chi |
| Nutrition counseling | Active comparator | Nutrition counseling for 12 weeks Receives: Other: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass changes from baseline assessment to 12 week follow-up assessment
Muscle mass changes from baseline assessment to 12 week follow-up assessment as determined my Bio Impedance Analysis
Measured: From baseline assessment to 12 week follow-up assessment
Secondary outcomes (4)
Body Fat Content changes from baseline assessment to 12 week follow-up
Changes of Body Fat Content (in %) from baseline assessment to 12 week follow-up assessment as determine by Bio Impedance Analysis
Measured: From baseline assessment to 12 week follow-up assessment
Body Fat Mass changes from baseline assessment to 12 week follow-up assessment
Body Fat Mass (kg) changes from baseline assessment to 12 week follow up assessment as determine by Bio Impedance Analysis
Measured: From baseline assessment to 12 week follow up assessment
Body mass changes from baseline assessment to 12 week follow-up assessment
Changes of body mass (weight in kg) from baseline assessment to 12 week follow-up assessment as determined by Bio Impedance Analysis
Measured: From baseline assessment to 12 week follow-up assessment
Body water changes from baseline assessment to 12 week follow-up assessment
Changes of body water from baseline assessment to 12 week follow-up assessment as determined by Bio Impedance Analysis
Measured: From baseline assessment to 12 week follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan AKÇAY, Karabuk University
- Investigators
- Neslihan AKÇAY, Doctorate, Study chair, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584578
- Sponsor's protocol ID
- UKarabuk-1
- Acronym
- FitNutrBC-12
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Willert S, Weissenfels A, Kohl M, von Stengel S, Frohlich M, Kleinoder H, Schone D, Teschler M, Kemmler W. Effects of Whole-Body Electromyostimulation on the Energy-Restriction-Induced Reduction of Muscle Mass During Intended Weight Loss. Front Physiol. 2019 Aug 12;10:1012. doi: 10.3389/fphys.2019.01012. eCollection 2019.
PubMed 31456693Kemmler W, Weissenfels A, Teschler M, Willert S, Bebenek M, Shojaa M, Kohl M, Freiberger E, Sieber C, von Stengel S. Whole-body electromyostimulation and protein supplementation favorably affect sarcopenic obesity in community-dwelling older men at risk: the randomized controlled FranSO study. Clin Interv Aging. 2017 Sep 21;12:1503-1513. doi: 10.2147/CIA.S137987. eCollection 2017.
PubMed 28989278
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition
- ClinicalTrials.gov ID
- NCT06584578
- Acronym / sponsor ID
- FitNutrBC-12 / UKarabuk-1
- Conditions
- Obesity, Overweight, Weight Loss, Muscle Maintenance
- Keywords
- Exercise, WB-EMS, Pilates, Yoga, Nutritional Guidance, Body Composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Sep 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.
Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition
The purpose of the study was to examine the effect of 12 weeks of different exercise training modalities and nutritional guidance on body composition.This study was conducted voluntarily by individuals who applied to a private health center in the Safranbolu district of Karabük and received medical nutrition treatment. It was conducted on four groups as Pilates, Yoga, WB-EMS and control and lasted 12 weeks in total. The training period of the participants in the group other than the control group was 2 days a week and 45 minutes per day, and 3 exercises consisted of warm-up, main part and cool-down parts. Some body composition assessments were made to the participants before and after their 12-week exercises. Body composition measurements (height, body weight, body mass index, body fat and muscle percentage) and systolic and diastolic blood pressure measurements were taken. Maximum heart rate (HRmax) (beats/min), average HR (beats/min), total calories burned (kcal) were determined to determine and monitor the load and intensity of each exercise for 12 weeks, and the Borg Scale was applied to the participants after each exercise to determine the degree of difficulty they perceived from the exercise they did and to evaluate their enjoyment of the exercises. Also, A personalized nutrition program prepared by a specialist dietitian for 12 weeks.
Detailed description
Height and Body Composition Measurements: Height measurements of the athletes participating in the study were made with a height scale with a precision of 0.01 mm. Body weight and body mass index measurements were determined with an INBODY 120 brand body fat analyzer.
Warm-up Protocol: participants performed the same warm-up protocol in all conditions, a general warm-up consisting of 10 min of full-body light stretching exercises (do Carmo et al. 2021).
Determination of Exercise Load and Intensity: In order to determine and follow the load and intensity of each exercise for 6 weeks, a Realtrack Seego brand pulse monitoring system (Spain) was used, which instantly records the maximum heart rate (HRmax) (beats/min), average HR (beats/min), and total calories burned (kcal) values, and the values were recorded by the researcher by watching them on the monitor.
Yoga Exercise Program: Each yoga session lasts 1.5 hours. The emphasis in yoga classes is on asana practice; all types of poses are included, including sitting, standing, balancing poses, kneeling, forward and backward bending, supine and prone positions and inversions. Classes always begin with a short body and breath scan and end with an 8-10 minute relaxation practice in Savasana (lying corpse pose). The scenarios for the sessions are prepared according to two valuable yoga books (Satyananda, 2002). Yoga trainings are performed by an expert trainer.
Pilates Exercise Program: The Pilates exercise program complied with the recommended amount of exercise for improving the health of the elderly, and the movements suitable for the elderly were selected from the work of Cathleen Murakami (Murakami, 2006). The Pilates exercise program included a five-minute warm-up exercise, and the order was as follows: breathing, 2 repetitions (repetitions); compression and release, 2 repetitions × 2 sets; supine spine, 2 repetitions × 2 sets; arm circles, 4 repetitions × 2 sets; knee-to-knee bending stretch, 2 repetitions × 2 sets; pelvic peel and hinge, 2 repetitions × 2 sets; arms crossed spine, 2 repetitions × 2 sets; and seated hip stretch, 2 repetitions. The main exercise was performed for 30 minutes in the following order: swim, 10 repetitions × 1 set; rolling and rolling, 3 repetitions × 2 sets; single leg circle, 5 repetitions × 2 sets. The cool-down exercise was performed in the same way as the warm-up exercise (Herman, 2008). Pilates training was performed by an expert trainer.
Nutritional Guidance: A personalized nutrition program was prepared for each participant by a dietician in a face-to-face meeting based on the individual's body analysis values (body fat, muscle mass, body water ratios), complete blood count results, lifestyle and eating habits, with daily calorie intake not below the Basal Metabolic Rate (BMR) and a protein value of at least 1.5 g/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Electomyostimulation (WB-EMS) | Experimental | Other: Whole-Body ElectromyostimulationWhole-Body Electromyostimulation |
| Pilates | Experimental | Other: PilatesPilates |
| Tai Chi | Experimental | Other: Tai ChiTai-Chi exercise |
| Nutrition counseling | Active comparator | Other: Nutritional counselingNutrition counseling for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being healthy
- Willing to maintain the intervention for 12 weeks
Key exclusion criteria (6 listed)
- Being under 18 years old
- Having a chronic disease
- Medication that relevantly affect muscle metabolism
- Contraindication for Bio Impedance Analysis
- Contraindication for Whole Body Electromyostimulation
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 |
|---|---|---|
| Whole-Body ElectromyostimulationAlso: Whole-Body Electromyostimulation exercise, Pilates exercise, Tai Chi exerciseParticipants were included in tree exercise programs (Yoga, Pilates, WB-EMS) by an expert trainer 2 days a week for 12 weeks. At the same time, an active control group conducted a weekly diet counseling for 12 weeks by an expert dietician. | Other | Whole-Body Electomyostimulation (WB-EMS) |
| PilatesPilates exercise twice weekly for 12 weeks | Other | Pilates |
| Tai ChiPilates exercise twice weekly for 12 weeks | Other | Tai Chi |
| Nutritional counselingNutritional counseling for 12 weeks | Other | Nutrition counseling |
Primary outcome
Muscle mass changes from baseline assessment to 12 week follow-up assessment
Time frame: From baseline assessment to 12 week follow-up assessment
Muscle mass changes from baseline assessment to 12 week follow-up assessment as determined my Bio Impedance Analysis
4 secondary outcomes
Body Fat Content changes from baseline assessment to 12 week follow-up
Time frame: From baseline assessment to 12 week follow-up assessment
Body Fat Mass changes from baseline assessment to 12 week follow-up assessment
Time frame: From baseline assessment to 12 week follow up assessment
Body mass changes from baseline assessment to 12 week follow-up assessment
Time frame: From baseline assessment to 12 week follow-up assessment
Body water changes from baseline assessment to 12 week follow-up assessment
Time frame: From baseline assessment to 12 week follow-up assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 31456693Willert S, Weissenfels A, Kohl M, von Stengel S, Frohlich M, Kleinoder H, Schone D, Teschler M, Kemmler W. Effects of Whole-Body Electromyostimulation on the Energy-Restriction-Induced Reduction of Muscle Mass During Intended Weight Loss. Front Physiol. 2019 Aug 12;10:1012. doi: 10.3389/fphys.2019.01012. eCollection 2019.
- Background: PubMed 28989278Kemmler W, Weissenfels A, Teschler M, Willert S, Bebenek M, Shojaa M, Kohl M, Freiberger E, Sieber C, von Stengel S. Whole-body electromyostimulation and protein supplementation favorably affect sarcopenic obesity in community-dwelling older men at risk: the randomized controlled FranSO study. Clin Interv Aging. 2017 Sep 21;12:1503-1513. doi: 10.2147/CIA.S137987. eCollection 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Neslihan AKÇAY, Doctorate study chair
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Electromyostimulation, Pilates and Tai Chi in people with Obesity and Overweight, run by Karabuk 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 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
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?
Muscle mass changes from baseline assessment to 12 week follow-up assessment (time frame: From baseline assessment to 12 week follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06584578, which also lists 2 linked publications.
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 5 Sep 2024.