Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women

Overweight Clinical Trial

Official title:

Effects of an Eight-week Diet Versus Diet Plus Aerobic and Resistant Exercise Program on Postural Control, Musculoskeletal Disorders, Functional Capacity, and Sleep in Overweight Women: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591794
• Other study ID #: 20.09.2022-78412
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Bezmialem Vakif University
• Contact: Deniz Tuncer, PhD, PT
• Phone: +905354273757
• Email: dtuncer[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adult women aged 18-50 years and overweight (preobese) with a BMI of 25-30 kg/m2 will be included in the study. Participants will participate in an eight-week diet and diet plus aerobic and resistance exercise program. Patients will be referred from the Nutrition and Diet Polyclinic of Bezmialem Vakıf University to this study, which will be conducted to investigate the effects of exercise program on postural control, musculoskeletal system disorders, functional capacity, and sleep.

Description:

Subjects who accepted to participate in the study will be randomized and divided into two groups as study and control groups. A computer-based randomization program (random.org) will be used to determine the cases to be assigned to the study and control groups. 2 numbers consisting of 12 numbers will be determined by random selection from the numbers between 1 and 24. The first of these number sequences will be considered as the study group and the second as the control group. Each patient included in the study will be asked to draw one of the sealed envelopes in which the numbers 1 to 24 are written. The case will be assigned to the study or control group according to the number sequence in which the drawn number is included. While the women in the study group are expected to perform regular walking with a diet for eight weeks and a 3-day aerobic and resistance exercise program per week, the subjects in the control group will be followed up with diet and regular walking. Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting nutrition program will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI between 25-29.9kg/m2

• Being between the ages of 18-50

• Agreeing to participate voluntarily in the study

Exclusion Criteria:

• Pregnancy

• Presence of systemic disease that will prevent participation in an aerobic exercise program

• Presence of conditions such as pain or surgery that will prevent participation in an aerobic exercise program

• Participating in a regular exercise program within the last 1 year

Related Conditions & MeSH terms

• Exercise
• Overweight

Intervention

Other:
• Aerobic and resistance exercises
Participants in the study group will be given an aerobic exercise program on the treadmill for 8 weeks, 2 days a week, 20 minutes at a rate of 60-80% of the target heart rate. Participants will work on the treadmill for 20 minutes at 60-70% of the target heart rate for the first four weeks, and at 70-80% of the target heart rate for the last four weeks. Resistance exercises will consist of exercises that will work large muscle groups with rubber bands. According to Borg, the resistance exercises to be applied will be three sets of 10 repetitions for each movement at an RPE of 11-12 during the first four weeks, and 3 sets of 15 repetitions at the same RPE for the last four weeks, 2 times a week for 20 minutes.

Dietary Supplement:
• Diet program
Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting diet will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.

Other:
• Regular walking program
Regular walking will be recommended as 30 minutes/5 days or 50 minutes/3 days per week.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of postural control by Biodex Balance System	Postural control evaluation will be performed with "Biodex Balance System®" (Biodex Medical Systems, Shirley, New York, USA) which is a valid and reliable equipment. Three tests will be performed with the device: postural stability test, stability limits test, and modified clinical test of sensory integration of balance. During the evaluation, three measurements of 20 seconds, 10 seconds intervals between each measurement, will be performed in all tests. Higher control over balance is indicated by a lower score of overall, anterior/posterior, and medial/lateral stability index in the PS test. However, a higher score indicates a lower level of postural control in stability limits and modified clinical test of sensory integration of balance tests.	Change between baseline and 8-week scores of Biodex Balance System.
Secondary	Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire	The Extended Nordic Musculoskeletal Questionnaire is a reliable instrument that measures the prevalence, severity and impact of musculoskeletal symptoms.	Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.
Secondary	Evaluation of functional capacity by 6 minute walk test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess functional capacity and endurance.	Change between baseline and 8-week scores of 6 Minute Walk Test.
Secondary	Evaluation of sleep quality by Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.	Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.