Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women
Primary Purpose
Overweight, Exercise
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic and resistance exercises
Diet program
Regular walking program
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Aerobic and resistance exercise, Postural control, Musculoskeletal disorders, Functional capacity, Sleep
Eligibility Criteria
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
Sites / Locations
- Bezmialem Vakif UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05591794
First Posted
October 12, 2022
Last Updated
April 25, 2023
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT05591794
Brief Title
Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Exercise
Keywords
Overweight, Aerobic and resistance exercise, Postural control, Musculoskeletal disorders, Functional capacity, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic and resistance exercises
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular walking program
Intervention Description
Regular walking will be recommended as 30 minutes/5 days or 50 minutes/3 days per week.
Primary Outcome Measure Information:
Title
Evaluation of postural control by Biodex Balance System
Description
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.
Time Frame
Change between baseline and 8-week scores of Biodex Balance System.
Secondary Outcome Measure Information:
Title
Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire
Description
The Extended Nordic Musculoskeletal Questionnaire is a reliable instrument that measures the prevalence, severity and impact of musculoskeletal symptoms.
Time Frame
Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.
Title
Evaluation of functional capacity by 6 minute walk test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess functional capacity and endurance.
Time Frame
Change between baseline and 8-week scores of 6 Minute Walk Test.
Title
Evaluation of sleep quality by Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Time Frame
Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Tuncer, PhD, PT
Phone
+905354273757
Email
dtuncer@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Tuncer, PhD, PT
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Tuncer, PhD, PT
Phone
+905354273757
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women
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