Essential Hypertension Clinical Trial
Official title:
Effects of Supervised Versus Unsupervised Aerobic Exercise Training on Weight Loss, Functional Capacity, Quality of Life and Depression Level in Patients With Essential Hypertension
NCT number | NCT05987436 |
Other study ID # | HKara2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | December 1, 2019 |
Verified date | August 2023 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | December 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University Faculty of Medicine | Konya |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | kilograms | was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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