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

NCT05591794 | Terminated

• 1 other identifier: 20.09.2022-78412
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Exercise

Keywords

Overweight; Aerobic and resistance exercise; Postural control; Musculoskeletal disorders; Functional capacity; Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire

  Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.

• Evaluation of functional capacity by 6 minute walk test

  Change between baseline and 8-week scores of 6 Minute Walk Test.

• Evaluation of sleep quality by Pittsburgh Sleep Quality Index

  Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.

Study Arms (2)

Study group

EXPERIMENTAL

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; Dietary Supplement: Diet program; Other: Regular walking program

Control group

ACTIVE COMPARATOR

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; Other: Regular walking program

Interventions

Aerobic and resistance exercises OTHER

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.

Study group

Diet program DIETARY_SUPPLEMENT

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.

Control group; Study group

Regular walking program OTHER

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

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 25-29.9kg/m2
• Being between the ages of 18-50
• Agreeing to participate voluntarily in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overweight; Motor Activity; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Deniz Tuncer, PhD, PT

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 24, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

TU (1)