OverweightNCT05591794
Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women
A study testing Aerobic and resistance exercises, Diet program and Regular walking program in people with Overweight and Exercise, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Exercise
- What is being tested?
- Aerobic and resistance exercises, Diet program and Regular walking program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25-29.9kg/m2
- Being between the ages of 18-50
- Agreeing to participate voluntarily in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Overweight, Exercise
- Being tested
- Aerobic and resistance exercises, Diet program, Regular walking program
- Keywords
- Overweight, Aerobic and resistance exercise, Postural control, Musculoskeletal disorders, Functional capacity, Sleep
- Medical subject headings
- Overweight, Motor Activity, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and resistance exercisesOther
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.
Diet programDietary 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.
Regular walking programOther
Regular walking will be recommended as 30 minutes/5 days or 50 minutes/3 days per week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Diet program; Other: Regular walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and 8-week scores of Biodex Balance System.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Sep 2022
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Why it stopped: The study was halted prematurely following the departure of two researchers, resulting in insufficient research capacity to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Deniz Tuncer, PhD, PT, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591794
- Sponsor's protocol ID
- 20.09.2022-78412
- Status last verified
- Feb 2026
- First submitted
- 12 Oct 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05591794
- Acronym / sponsor ID
- 20.09.2022-78412
- Conditions
- Overweight, Exercise
- Keywords
- Overweight, Aerobic and resistance exercise, Postural control, Musculoskeletal disorders, Functional capacity, Sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted prematurely following the departure of two researchers, resulting in insufficient research capacity to continue the study.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Aerobic and resistance exercises, Dietary Supplement: Diet program, Other: Regular walking programThe 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. |
| Control group | Active comparator | Dietary Supplement: Diet program, Other: Regular walking programThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 25-29.9kg/m2
- Being between the ages of 18-50
- Agreeing to participate voluntarily in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic and resistance exercisesParticipants 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. | Other | Study group |
| Diet programInitially, 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. | Dietary supplement | Control group, Study group |
| Regular walking programRegular walking will be recommended as 30 minutes/5 days or 50 minutes/3 days per week. | Other | Control group, Study group |
Primary outcome
Evaluation of postural control by Biodex Balance System
Time frame: Change between baseline and 8-week scores of 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.
3 secondary outcomes
Evaluation of musculoskeletal by Extended Nordic Musculoskeletal Questionnaire
Time frame: Change between baseline and 8-week scores of Extended Nordic Musculoskeletal Questionnaire.
Evaluation of functional capacity by 6 minute walk test
Time frame: Change between baseline and 8-week scores of 6 Minute Walk Test.
Evaluation of sleep quality by Pittsburgh Sleep Quality Index
Time frame: Change between baseline and 8-week scores of Pittsburgh Sleep Quality Index.
Results and safety
The study was stopped early (reason given: The study was halted prematurely following the departure of two researchers, resulting in insufficient research capacity to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Tuncer, PhD, PT principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and resistance exercises, Diet program and Regular walking program in people with Overweight and Exercise, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was halted prematurely following the departure of two researchers, resulting in insufficient research capacity to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of postural control by Biodex Balance System (time frame: Change between baseline and 8-week scores of Biodex Balance System.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.