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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05251597
Other study ID # Green exercise
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2022
Est. completion date November 12, 2022

Study information

Verified date March 2022
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 12, 2022
Est. primary completion date October 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
green exercise with aerobic exercise
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.

Locations

Country Name City State
Turkey Emel Mete Istanbul
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline physical activity level at week 12.
Primary blood pressure Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer. Change from baseline blood pressure at week 12.
Primary 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 . Change from baseline hemoglobin A1c at week 12.
Primary 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. Change from baseline lipid profile at week 12.
Primary 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. Change from baseline fasting blood glucose at week 12.
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