NCT05413434

Brief Summary

The study will be conducted on individuals with Metabolic Syndrome. There are many studies showing that aerobic exercise provides significant improvements in waist circumference, fasting glucose, high-density lipoprotein cholesterol (HDL-C), Triglyceride (TG), systolic and diastolic blood pressure (SBP-DBP), and cardiorespiratory fitness on METS parameters. However, although the beneficial effects of physical activity are known, only half of the population adheres to the 150 minutes of moderate-intensity physical activity per week recommendation. High-intensity interval training (HIIT) is a type of training that uses near-maximal intensities in short-term sessions. HIIT has been used to improve compliance because it requires less time to treat patients with cardiometabolic disease. Compared to continuous aerobic exercise, this type of training has been shown to be an effective alternative for improving maximum oxygen consumption (VO2 max), blood pressure, heart function, glucose and lipid metabolism, and markers of oxidative stress and inflammation. In the literature, HIIT has been studied in patients with METS and has been shown to be effective. In addition, a study showed that seven-day respiratory muscle training was also effective on METS parameters, but there is no study showing the long-term effects of respiratory muscle training in this patient group. Therefore, in our study, researchers aimed to show the effects of respiratory muscle training given with HIIT on METS parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

March 6, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

March 6, 2022

Last Update Submit

August 11, 2023

Conditions

Keywords

metabolic syndromeinspiratory muscle traininghigh intensity interval trainingexercise

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Cardiorespiratory fitness will be performed using a cardiopulmonary exercise test (CPET) with a treadmill, using the measurement method (breath by breath) with each breath. The modified Bruce protocol will be applied.VO2max will be recorded in ml/kg/min.

    8 weeks

Secondary Outcomes (17)

  • functional capacity

    8 weeks

  • flexibility

    8 weeks

  • systolic and diastolic blood pressure

    8 weeks

  • C-Reactive Protein (CRP)

    8 weeks

  • Low Density Lipoprotein Cholesterol (LDL-C)

    8 weeks

  • +12 more secondary outcomes

Study Arms (3)

HIIT with a supervisor

EXPERIMENTAL

These individuals will be given HIIT training on the treadmill, accompanied by a physiotherapist, 3 days a week for 8 weeks.

Other: exercise

Hiit and respiratory muscle training with a supervisor

EXPERIMENTAL

HIIT program and respiratory muscle training will be applied to these individuals 3 days a week for 8 weeks.

Other: exerciseDevice: inspiratory muscle training

control group

NO INTERVENTION

The importance of physical activity will be explained and appropriate physical activity recommendations will be made.

Interventions

high-intensity interval training will be performed on the treadmill.

HIIT with a supervisorHiit and respiratory muscle training with a supervisor

Respiratory muscle strength exercise will be performed with the respiratory muscle strengthening device 'POWERbreathe Classic Light Resistance'.

Hiit and respiratory muscle training with a supervisor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • METS will be defined according to the National Adult Cholesterol Education Program Adult Treatment Panel III. Patients with at least three or more of the following five characteristics will be included in the study:
  • Waist circumference ≥102 cm for men or ≥88 cm for women;
  • blood pressure above 130/85 mmHg;
  • Fasting blood glucose (FG) ≥100 mg/dL;
  • Blood TG ≥150 mg/dL; and
  • HDL-C \< 40 mg/dL for men and \< 50 mg/dL for women.
  • Not participating in any physical activity program (≤2 physical activity days per week ≤ 30 minutes per session).
  • years
  • to walk and cooperate
  • to participate in the research

You may not qualify if:

  • heart failure,
  • pectoris,
  • of myocardial infarction or stroke in less than one year,
  • hypertension,
  • cardiovascular or kidney disease,
  • with peripheral vascular disease and any disease associated with exercise intolerance will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

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 Officials

  • oğuz uyaroglu, PHD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The physician who referred patients to the study and the participants were blind to the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master off degree

Study Record Dates

First Submitted

March 6, 2022

First Posted

June 10, 2022

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Study protocol and data analysis will be shared with other researchers.

Locations