NCT05251597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 27, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

December 23, 2021

Last Update Submit

March 28, 2022

Conditions

Keywords

metabolic syndromeexercisegeriatrics

Outcome Measures

Primary Outcomes (5)

  • 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.

  • blood pressure

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

    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 .

    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.

    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.

    Change from baseline fasting blood glucose at week 12.

Study Arms (3)

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

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.

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.

Interventions

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.

Also known as: green exercise with aerobic and resistance exercises
green exercise group-1 (aerobic)green exercise group-2 (aerobic+resistance)

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medeniyet University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Emel Mete

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Metabolic SyndromeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
None (Open Label)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

December 23, 2021

First Posted

February 22, 2022

Study Start

March 27, 2022

Primary Completion

October 8, 2022

Study Completion

November 12, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations