Effect of Aerobic Exercise in Patients With Essential Hypertension

Effects of Supervised Versus Unsupervised Aerobic Exercise Training on Weight Loss, Functional Capacity, Quality of Life and Depression Level in Patients With Essential Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension; Aerobic Exercise
• Intervention / Treatment: Other: Supervised Aerobic Exercise

Detailed Description

Patients who chose the treatment type according to personal preferences were divided into two groups: Group 1(n:91) exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to maintain dietary habits and physical activity levels. Body weight, serum lipid levels, functional capacity, QoL, and depression level of all the participants were evaluated at baseline and 6 weeks later.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selçuk University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with Essential Hypertension

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; functional capacity; essential hypertension; supervised aerobic exercise; depression level
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: HKara2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No