Effect of Aerobic Exercise in Patients With Essential Hypertension

NCT05987436 | Completed

• 1 other identifier: HKara2
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the effects of a supervised aerobic exercise training program on weight loss, functional capacity, quality of life (QoL), and depression levels in patients with essential hypertension.

Conditions

Aerobic Exercise; Essential Hypertension

Keywords

supervised aerobic exercise; functional capacity; quality of life; depression level; essential hypertension

Outcome Measures

Primary Outcomes (5)

• Body weight

  kilograms

  was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician.

• Blood samples

  Serum total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, and triglycerides

  Twelve-hour fasting blood samples were collected between 6.00 am, and 10.00 am at baseline and week 6.

• The functional capacity

  The 6MWT test and the estimated metabolic equivalents or METs were used performed to evaluate functional capacity.

  6MWT was assessed in face-to-face interviews before and immediately after the treatment was completed.

• Quality of Life

  Quality of life was assessed with Short Form-36 (SF-36).

  SF36 was assessed in face-to-face interviews before and immediately after the treatment was completed.

• Depression level

  Depression level was assessed Beck Depression Inventory (BDI).

  BDI was assessed in face-to-face interviews before and immediately after the treatment was completed.

Study Arms (2)

Group 1

Group 1 exercised for six weeks, involving once per day, five sessions per week under the supervision of a medical doctor, and a nurse in the aerobic exercise laboratory. The aerobic exercise training program lasted six weeks, and patients lived in the hospital for the whole period. Aerobic exercise training was performed on cycle ergometers (Ergoline, ergoselect II 100/200/Reha, Germany) equipped with a computed ergometer and developed to monitor electrocardiography (ECG), heart rhythm, and BP. Each session consisted of a 5-minute warm-up, followed by 50 minutes of aerobic exercise with an intensity of 50% to 70% of heart rate reserve, calculated by Karvonen formula, and ended with a 5-min cool-down period.

Other: Supervised Aerobic Exercise

Group 2

The subjects assigned to the control group (Group 2) were advised to maintain dietary habits and physical activity levels and the aerobic exercise program was provided to them after completing the study.

Interventions

Supervised Aerobic Exercise OTHER

Group 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory.

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Essential Hypertension

You may qualify if:

• Over 18 years of age,
• Absence of concomitant other metabolic and cardiovascular diseases.

You may not qualify if:

• Having suffered an event of ischaemic heart disease (\<6 months),
• Secondary hypertension,
• Hypertrophic obstructive cardiomyopathy,
• Congestive heart failure,
• Uncontrolled cardiac arrhythmia,
• Thyroid dysfunction,
• Diabetes mellitus,
• Symptomatic peripheral arterial occlusive disease,
• Aortic insufficiency or stenosis,
• Pulmonary or heart disease with dyspnoea at small or moderate effort,
• An outbreak of orthopedic problems on hip, knee or ankles, such as arthroplasty, contracture or severe osteoarthritis,
• Using of antidepressant or anxiolytic drugs,
• Pregnancy,
• Cognitive disfunction.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Selcuk University Faculty of Medicine

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)