Exercise Nutrition and Body Composition

NCT ID: NCT06584578

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight Weight Loss Muscle Maintenance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participants were strictly separated and think their intervention is the main intervention. The same is true for care providers. Outcome assessors were unaware of participant group status and were not allowed to ask correspondingly

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Whole-Body Electomyostimulation (WB-EMS)

Whole-Body Electromyostimulation

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation

Intervention Type OTHER

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.

Pilates

Pilates

Group Type EXPERIMENTAL

Pilates

Intervention Type OTHER

Pilates exercise twice weekly for 12 weeks

Tai Chi

Tai-Chi exercise

Group Type EXPERIMENTAL

Tai Chi

Intervention Type OTHER

Pilates exercise twice weekly for 12 weeks

Nutrition counseling

Nutrition counseling for 12 weeks

Group Type ACTIVE_COMPARATOR

Nutritional counseling

Intervention Type OTHER

Nutritional counseling for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole-Body Electromyostimulation

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.

Intervention Type OTHER

Pilates

Pilates exercise twice weekly for 12 weeks

Intervention Type OTHER

Tai Chi

Pilates exercise twice weekly for 12 weeks

Intervention Type OTHER

Nutritional counseling

Nutritional counseling for 12 weeks

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Whole-Body Electromyostimulation exercise Pilates exercise Tai Chi exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being healthy
* Willing to maintain the intervention for 12 weeks

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karabuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Neslihan AKÇAY

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neslihan AKÇAY, Doctorate

Role: STUDY_CHAIR

Karabuk University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karabuk University

Karabük, Centre, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31456693 (View on PubMed)

Kemmler 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.

Reference Type BACKGROUND
PMID: 28989278 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UKarabuk-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Quadriceps Concentric vs Eccentric
NCT03636854 COMPLETED NA
Fitness Study 2020
NCT04392752 UNKNOWN NA