Metabolic SyndromeNCT05251597
Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals
A study testing green exercise with aerobic exercise in people with Metabolic Syndrome, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- green exercise with aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Mar 2022to 12 Nov 2022
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- people aged over 65 years
- Be fit to participate in exercise program after the first cardiac examination by the physician
- Individuals whose blood lipids, Hg a1c and glucose values were checked within 3 months
- According to the International Physical Activity Assessment Questionnaire, those who are physically inactive
- Having a score above 24 in the Minimental Test
Who cannot join
- Having neuromuscular disease
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having an orthopedic disease that interferes with walking
- Having a score below 24 in the Minimental Test
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, 34000
emel mete, 05376096265, e_emel86@hotmail.com
- Recruiting
Emel Mete
Istanbul, 34854
EMEL METE, +905376096265, e_emel86@hotmail.com
About this study
Official title: Comparison of the Effects of Green Exercise Programs Including Resistance Exercises and Aerobic Exercises on Metabolic Syndrome Parameters in Elderly Individuals
The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.
Read the detailed description
One hundred twenty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. While a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. Exercises will be held in an open and green area. At the beginning of the treatment and at the end of the twelfth week Hemoglobin A1c (HbA1c), Triglyceride, Hdl cholesterol, Ldl cholesterol, total cholesterol and blood glucose will be evaluated.
- Conditions
- Metabolic Syndrome
- Being tested
- green exercise with aerobic exercise
- Keywords
- metabolic syndrome, exercise, geriatrics
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green exercise with aerobic exerciseOther
Also called green exercise with aerobic and resistance exercises
Green exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. It is mostly applied in the form of brisk walking in the open air.
| Study group | Role | What they receive |
|---|---|---|
| green exercise group-1 (aerobic) | Experimental | Forty participants who meet the inclusion criteria will first be given warm-up exercises for 10 minutes, then walking at a moderate intensity (65% of heart rate) for 40 minutes and then stretching exercises for 5 minutes Receives: Other: green exercise with aerobic exercise |
| green exercise group-2 (aerobic+resistance) | Experimental | For 40 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 10 minutes of low-intensity (50% of the maximum repetitions) and 10 minutes of high-intensity (80% of the maximum repetitions) resistance exercises will be applied in the presence of a physiotherapist. resistance exercises; shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle group will be performed. At the end of each session, 5 minutes of stretching exercises will also be applied. Receives: Other: green exercise with aerobic exercise |
| Control group | No intervention | The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity level
physical activity level will be evaulated with international physical activity questionnairre (IPAQ). The questionnaire is based on calculating the MET (metabolic equivalent) value spent by evaluating at least 10 minutes of physical activity in the last seven days in terms of frequency, duration (minutes) and intensity. According to this questionnaire, physical activity level is categorized into 4 classes: inactive, not active enough, active, very active.
Measured: Change from baseline physical activity level at week 12.
blood pressure
Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.
Measured: Change from baseline blood pressure at week 12.
hemoglobin A1c
After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. HbA1c will be measured using the Chromatography method with a com-mercial kit .
Measured: Change from baseline hemoglobin A1c at week 12.
lipid profile
HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride serum levels will be measured to evaluate the lipid profile.HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride will be assessed using enzymatic colorimetry with commercial kits.
Measured: Change from baseline lipid profile at week 12.
fasting blood glucose
After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. Fasting blood samples from the antecubital vein will be collected by vacuum tubes. For biochemical analysis, Fasting blood glucose will be assessed with a commercial kit.
Measured: Change from baseline fasting blood glucose at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start27 Mar 2022
- Primary completion8 Oct 2022 (estimated)
- Study completion12 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Parallel Assignment Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251597
- Sponsor's protocol ID
- Green exercise
- Status last verified
- Mar 2022
- First submitted
- 23 Dec 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayaz EY, Dincer B, Cinbaz G, Karacan E, Benli RK, Mete E, Bilgic H, Mesci B. The Effect of Exercise on Spexin and Follistatin in Elderly Individuals. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13692. doi: 10.1002/jcsm.13692.
PubMed 39895162
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Green Exercise Programs Including Resistance Exercises and Aerobic Exercises on Metabolic Syndrome Parameters in Elderly Individuals
- ClinicalTrials.gov ID
- NCT05251597
- Acronym / sponsor ID
- Green exercise
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, exercise, geriatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 8 Oct 2022 (estimated)
- Study completion
- 12 Nov 2022 (estimated)
- First posted
- 22 Feb 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.
The aim of this study is to compare the effects of exercise programs that only aerobic exercise and combination aerobic exercise and resistance exercises on the metabolic syndrome parameters in the green exercise concept.
Detailed description
One hundred twenty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into three groups as aerobic, aerobic and resistance and control group. While a group will receive only aerobic exercise, the other group group will receive both aerobic and resistance exercises and one of the group will receive no exercise. Exercises will be held in an open and green area. At the beginning of the treatment and at the end of the twelfth week Hemoglobin A1c (HbA1c), Triglyceride, Hdl cholesterol, Ldl cholesterol, total cholesterol and blood glucose will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment Randomized
| Arm | Type | Receives |
|---|---|---|
| green exercise group-1 (aerobic) | Experimental | Other: green exercise with aerobic exerciseForty participants who meet the inclusion criteria will first be given warm-up exercises for 10 minutes, then walking at a moderate intensity (65% of heart rate) for 40 minutes and then stretching exercises for 5 minutes |
| green exercise group-2 (aerobic+resistance) | Experimental | Other: green exercise with aerobic exerciseFor 40 participants who met the inclusion criteria, first 10 minutes of warm-up exercises, then 20 minutes of moderate-intensity (65% of heart rate) walking, followed by 10 minutes of low-intensity (50% of the maximum repetitions) and 10 minutes of high-intensity (80% of the maximum repetitions) resistance exercises will be applied in the presence of a physiotherapist. resistance exercises; shoulder flexors and abductors, elbow flexors and extensors, hip flexors and extensors, knee flexors and extensors, hip abductor muscle group will be performed. At the end of each session, 5 minutes of stretching exercises will also be applied. |
| Control group | No intervention | –The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- people aged over 65 years
- Be fit to participate in exercise program after the first cardiac examination by the physician
- Individuals whose blood lipids, Hg a1c and glucose values were checked within 3 months
- According to the International Physical Activity Assessment Questionnaire, those who are physically inactive
- Having a score above 24 in the Minimental Test
Key exclusion criteria (4 listed)
- Having neuromuscular disease
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
- Having an orthopedic disease that interferes with walking
- Having a score below 24 in the Minimental Test
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 |
|---|---|---|
| green exercise with aerobic exerciseAlso: green exercise with aerobic and resistance exercisesGreen exercise is a type of exercise done outdoors. It is an advantageous type of exercise in benefiting from sunlight and reducing anxiety. It is mostly applied in the form of brisk walking in the open air. | Other | green exercise group-1 (aerobic), green exercise group-2 (aerobic+resistance) |
Primary outcome
physical activity level
Time frame: Change from baseline physical activity level at week 12.
physical activity level will be evaulated with international physical activity questionnairre (IPAQ). The questionnaire is based on calculating the MET (metabolic equivalent) value spent by evaluating at least 10 minutes of physical activity in the last seven days in terms of frequency, duration (minutes) and intensity. According to this questionnaire, physical activity level is categorized into 4 classes: inactive, not active enough, active, very active.
blood pressure
Time frame: Change from baseline blood pressure at week 12.
Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.
hemoglobin A1c
Time frame: Change from baseline hemoglobin A1c at week 12.
After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. HbA1c will be measured using the Chromatography method with a com-mercial kit .
lipid profile
Time frame: Change from baseline lipid profile at week 12.
HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride serum levels will be measured to evaluate the lipid profile.HDL cholesterol, LDL cholesterol, total cholesterol and triglyceride will be assessed using enzymatic colorimetry with commercial kits.
fasting blood glucose
Time frame: Change from baseline fasting blood glucose at week 12.
After 12-14 hr of fasting, a 10 cc blood sample will be collected from each participant. Fasting blood samples from the antecubital vein will be collected by vacuum tubes. For biochemical analysis, Fasting blood glucose will be assessed with a commercial kit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 39895162Ayaz EY, Dincer B, Cinbaz G, Karacan E, Benli RK, Mete E, Bilgic H, Mesci B. The Effect of Exercise on Spexin and Follistatin in Elderly Individuals. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13692. doi: 10.1002/jcsm.13692.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green exercise with aerobic exercise in people with Metabolic Syndrome, run by Istanbul Medeniyet University at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity level (time frame: Change from baseline physical activity level at week 12.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251597, which also lists 1 linked publication.
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 29 Mar 2022.