Aerobic ExerciseNCT05987436
Effect of Aerobic Exercise in Patients With Essential Hypertension
An observational study of Aerobic Exercise and Essential Hypertension, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Essential Hypertension
- What is being tested?
- Supervised Aerobic Exercise
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Essential Hypertension
Who may be able to join
- Over 18 years of age,
- Absence of concomitant other metabolic and cardiovascular diseases.
Who cannot join
- Having suffered an event of ischaemic heart disease (<6 months),
- Secondary hypertension,
- Hypertrophic obstructive cardiomyopathy,
- Congestive heart failure,
- Uncontrolled cardiac arrhythmia,
- Thyroid dysfunction,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aerobic Exercise, Essential Hypertension
- Being tested
- Supervised Aerobic Exercise
- Keywords
- supervised aerobic exercise, functional capacity, quality of life, depression level, essential hypertension
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic ExerciseOther
Group 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
kilograms
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: BDI was assessed in face-to-face interviews before and immediately after the treatment was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Nov 2017
- Primary completion1 Apr 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kara, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987436
- Sponsor's protocol ID
- HKara2
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05987436
- Acronym / sponsor ID
- HKara2
- Conditions
- Aerobic Exercise, Essential Hypertension
- Keywords
- supervised aerobic exercise, functional capacity, quality of life, depression level, essential hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Supervised Aerobic ExerciseGroup 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Essential Hypertension
Key inclusion criteria (2 listed)
- Over 18 years of age,
- Absence of concomitant other metabolic and cardiovascular diseases.
Key exclusion criteria (14 listed)
- Having suffered an event of ischaemic heart disease (<6 months),
- Secondary hypertension,
- Hypertrophic obstructive cardiomyopathy,
- Congestive heart failure,
- Uncontrolled cardiac arrhythmia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Aerobic ExerciseGroup 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory. | Other | Group 1 |
Primary outcome
Body weight
Time frame: was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician.
kilograms
Blood samples
Time frame: Twelve-hour fasting blood samples were collected between 6.00 am, and 10.00 am at baseline and week 6.
Serum total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, and triglycerides
The functional capacity
Time frame: 6MWT was assessed in face-to-face interviews before and immediately after the treatment was completed.
The 6MWT test and the estimated metabolic equivalents or METs were used performed to evaluate functional capacity.
Quality of Life
Time frame: SF36 was assessed in face-to-face interviews before and immediately after the treatment was completed.
Quality of life was assessed with Short Form-36 (SF-36).
Depression level
Time frame: BDI was assessed in face-to-face interviews before and immediately after the treatment was completed.
Depression level was assessed Beck Depression Inventory (BDI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aerobic Exercise and Essential Hypertension, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: was measured at the pre-treatment period and the post-treatment 6th week for all the participants by the same physician.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.