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Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
green exercise with aerobic exercise
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, exercise, geriatrics

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Medeniyet UniversityRecruiting
  • Emel MeteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

green exercise group-1 (aerobic)

green exercise group-2 (aerobic+resistance)

Control group

Arm Description

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

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.

The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.

Outcomes

Primary Outcome Measures

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.
blood pressure
Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.
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 .
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2021
Last Updated
March 28, 2022
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05251597
Brief Title
Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals
Official Title
Comparison of the Effects of Green Exercise Programs Including Resistance Exercises and Aerobic Exercises on Metabolic Syndrome Parameters in Elderly Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
October 8, 2022 (Anticipated)
Study Completion Date
November 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, exercise, geriatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Randomized
Masking
Participant
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
green exercise group-1 (aerobic)
Arm Type
Experimental
Arm Description
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
Arm Title
green exercise group-2 (aerobic+resistance)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The exercise program will not be implemented. Evaluations will be made at the beginning and end of the study.
Intervention Type
Other
Intervention Name(s)
green exercise with aerobic exercise
Other Intervention Name(s)
green exercise with aerobic and resistance exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
physical activity level
Description
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.
Time Frame
Change from baseline physical activity level at week 12.
Title
blood pressure
Description
Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.
Time Frame
Change from baseline blood pressure at week 12.
Title
hemoglobin A1c
Description
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 .
Time Frame
Change from baseline hemoglobin A1c at week 12.
Title
lipid profile
Description
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.
Time Frame
Change from baseline lipid profile at week 12.
Title
fasting blood glucose
Description
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.
Time Frame
Change from baseline fasting blood glucose at week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emel mete
Phone
05376096265
Email
e_emel86@hotmail.com
Facility Name
Emel Mete
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMEL METE
Phone
+905376096265
Email
e_emel86@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of the Effects of Green Exercise Programs on Metabolic Syndrome Parameters in Elderly Individuals

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