Clinical trial NCT06584578: Exercise Nutrition and Body Composition
Official title: Effect of 12 Weeks of Different Exercise Training Modalities and Nutritional Guidance on Body Composition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Muscle Maintenance
Keywords: Exercise
WB-EMS
Pilates
Yoga
Nutritional Guidance
Body Composition
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle mass changes from baseline assessment to 12 week follow-up assessment
timeFrame: From baseline assessment to 12 week follow-up assessment
Secondary outcomes:
measure: Body Fat Content changes from baseline assessment to 12 week follow-up
timeFrame: From baseline assessment to 12 week follow-up assessment
measure: Body Fat Mass changes from baseline assessment to 12 week follow-up assessment
timeFrame: From baseline assessment to 12 week follow up assessment
measure: Body mass changes from baseline assessment to 12 week follow-up assessment
timeFrame: From baseline assessment to 12 week follow-up assessment
measure: Body water changes from baseline assessment to 12 week follow-up assessment
timeFrame: From baseline assessment to 12 week follow-up assessment
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
state: Centre
Study officials:
affiliation: Karabuk University
name: Neslihan AKÇAY, Doctorate
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.