NCT06083376

Brief Summary

It has been suggested that Epicardial Adipose Tissue (EAT) may be an adjunctive marker to classical risk factors for the presence and severity of coronary artery disease. EAT thickness is also associated with MetS and hypertension, high levels of low-density lipoprotein cholesterol and insulin resistance.Studies have shown that moderate-intensity and high-intensity aerobic exercise and resistance exercise training reduce EAT. However, aerobic and resistance exercises may be found challenging and demanding by individuals and in most cases, high or moderate intensity exercise may be considered difficult. In a study conducted in physically inactive individuals, it was concluded that there was a significant increase in heart rate and BP following spinal stabilisation exercises performed 4 days a week for a total of 8 sessions for 2 weeks, but the increase in these cardiac parameters would tend to decrease following regular exercise. In the current literature, there is no study evaluating the effect of spinal stabilisation exercise on EAT thickness, exercise capacity and cardiovascular parameters in individuals with HT. Barriers to access to healthcare services such as distance, time and cost can be overcome with technology. COVID-19 has accelerated the transition of many physiotherapy services to telerehabilitation. Evidence has shown that telerehabilitation is an effective delivery model for providing face-to-face physiotherapy services with equal or even superior outcomes, especially in musculoskeletal treatment. The aim of this study was to determine the effect of spinal stabilisation exercise with telerehabilitation on EAT and exercise capacity in individuals with HT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable hypertension

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

October 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

October 5, 2023

Last Update Submit

April 30, 2025

Conditions

Keywords

Epicardial adipose tissueHypertensionExercises CapacityTelerehabilitationspinal stabilisation exercise

Outcome Measures

Primary Outcomes (2)

  • Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise

    All patients underwent transthoracic echocardiography conducted by a single cardiologist using a Philips HD11XE (Philips Medical Systems) device in the left lateral decubitus position by the standard technique. Epicardial fat thickness was measured in the parasternal long axis imaging window, using the aortic annulus as an anatomical indicator for vertical measurement, and the widest part of the region from the right ventricular free wall to the pericardium at the end of the systole.

    baseline and 8 weeks

  • Change in exercises capacity after 8 weeks-24 sessions of exercise

    The six-minute walk test (6MWT) will be administered to all participants twice on the same day, half an hour apart. Patients will rest for 10 minutes before the test is performed. Subjects will be asked to walk as fast as possible at their own walking speed for 6 minutes in a 30-meter straight corridor. Every minute during the test, standard phrases will be used to encourage the patient. At the end of the test, 6 minutes walking distance will be recorded. There is no minimum or maximum value as it depends on the person's performance. Longer walking distance indicates better functional capacity.

    baseline and 8 weeks

Secondary Outcomes (12)

  • Change in blood pressure after 8 weeks-24 sessions of exercise

    baseline and 8 weeks

  • Change in heart rate after 8 weeks-24 sessions of exercise

    baseline and 8 weeks

  • Change in Evaluation of Spinal Stabilisation Endurance after 8 weeks-24 sessions of exercise

    baseline and 8 weeks

  • Evaluation of Stabilisation Strength of Deep Spinal Muscles after 8 weeks-24 sessions of exercise

    baseline and 8 weeks

  • Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise

    baseline and 8 weeks

  • +7 more secondary outcomes

Study Arms (2)

exercise group

EXPERIMENTAL
Other: Spinal Stabilization Exercise

control group

ACTIVE COMPARATOR
Other: physical activity counseling

Interventions

Spinal stability exercises are commonly used isometric and isotonic exercises. A spinal stabilization exercise training program will be applied to the exercise group participants using the telerehabilitation method (simultaneous connection) 3 days a week for 8 weeks and a total of 24 sessions.

exercise group

Control group participants will first be given initial evaluations and verbal physical activity recommendations will be given. Patients will be contacted by phone at the 2nd, 4th and 6th weeks and reminded about the importance of physical activity.

control group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being followed up with Hypertension for at least 6 months
  • Volunteering to participate in the study
  • Speaking Turkish
  • Being literate
  • Not having participated in any structured exercise programme for at least 6 months

You may not qualify if:

  • Severe valvular disease
  • Having heart failure
  • Having cardiomyopathy
  • Myocardial infarction at least 6 months ago
  • Stable or unstable angina pectoris
  • Left ventricular ejection fraction below 40
  • Presence of peripheral artery disease
  • History of deep vein thrombosis, pulmonary embolism or stroke in the past
  • Chronic kidney disease
  • Having thyroid diseases
  • Active infectious or inflammatory disease
  • Body Mass Index \>40 kg/m2
  • Having a serious psychiatric illness such as panic disorder or major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Merkez, Karaman, Turkey (Türkiye)

Location

Related Publications (1)

  • Tunc Suygun E, Suygun H, Senalp ZE, Vardar Yagli N. The effect of telerehabilitation-based core stabilization exercises on epicardial fat tissue and exercise capacity in hypertensives. Disabil Rehabil. 2025 Nov 24:1-12. doi: 10.1080/09638288.2025.2593190. Online ahead of print.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 16, 2023

Study Start

December 1, 2023

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations