Clinical trial NCT06083376: Effect of Spinal Stabilization Exercises on Epicardial Fat Tissue and Exercise Capacity in Hypertensives
Official title: Effect of Telerehabilitation-based Spinal Stabilization Exercises on Epicardial Adipose Tissue and Exercises Capacity in Individuals With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Epicardial adipose tissue
Hypertension
Exercises Capacity
Telerehabilitation
spinal stabilisation exercise
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karaman Training and Research Hospital
First posted: 2023-10-16
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Being followed up with Hypertension for at least 6 months
2. Volunteering to participate in the study
3. Speaking Turkish
4. Being literate
5. Not having participated in any structured exercise programme for at least 6 months

Exclusion Criteria:

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

Primary outcomes:
measure: Change in epicardial fat tissue thickness after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Change in exercises capacity after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in blood pressure after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Change in heart rate after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Change in Evaluation of Spinal Stabilisation Endurance after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Stabilisation Strength of Deep Spinal Muscles after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Peripheral Muscle Strength after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of functional mobility and balance after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Quality of Life after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of healthy life profile after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Activity of Daily Living after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Activity of Physical Activity after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
measure: Evaluation of Self-Efficacy and Self-Management after 8 weeks-24 sessions of exercise
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Karamanoğlu Mehmetbey University
state: Karaman
Study officials:
References: