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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight; Exercise
• Intervention / Treatment: Other: Aerobic and resistance exercises; Dietary supplement: Diet program; Other: Regular walking program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniz Tuncer, PhD, PT; Phone Number: +905354273757; Email: dtuncer@bezmialem.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Bezmialem Vakif University
    • Contact: Deniz Tuncer, PhD, PT; Phone Number: +905354273757

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The women in the study group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program for eight weeks and aerobic and resistance exercise program 3 days a week.	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.
Active Comparator: Control group; The women in the control group will be asked to walk for 30 minutes/5 days or 50 minutes/3 days a week while performing a diet program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Deniz Tuncer, PhD, PT, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Overweight; Sleep; Postural control; Functional capacity; Musculoskeletal disorders; Aerobic and resistance exercise
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 20.09.2022-78412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No