Hypertension and BalanceNCT05187702
The Effect of Functional Exercise Training on Patients With Hypertension
A study testing Functional exersize and Aerobic exersize in people with Hypertension and Balance, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
It is the ability to keep and maintain the body training balance control center. Dynamic balance is the ability to maintain an individual's static position while the movement and posture are active while static. With aging, it is thought that the system will be applied in practice. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hypertension and Balance
- What is being tested?
- Functional exersize and Aerobic exersize
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCyprus
- Study dates
- 28 Jun 2022to 30 Sep 2022
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with HT (at least 6 months),
- Individuals who are independent in activities of daily living,
Who cannot join
- Those with neurological disease
- Those with Anxiety, Uncontrollable Hypertension, Chronic systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
It is the ability to keep and maintain the body training balance control center. Dynamic balance is the ability to maintain an individual's static position while the movement and posture are active while static. With aging, it is thought that the system will be applied in practice. Control of cerebral blood flow and synapse, which decreases with advanced age and hypertension, continues. In addition to slowing down in mental functions such as memory and learning, it progresses and accelerates in the sense of vibration, nerve velocity, proprioceptor feedback under skin receptor control, and can occur in static, dynamic and isokinetic muscle strength. This causes you to continue the preparations for the necessary evaluations in your postural stability and you watch. Particularly geriatrics reported that Otogo supports us to improve balance in us.
The purpose of this goal is to test in otago educational work on static and dynamic movements, lower hypertensive muscle work, capacity and capacity and competence.
Read the detailed description
It is the ability to keep and maintain the body training balance control. Dynamic balance is the ability to maintain an individual's static position while the movement and posture are active while static. With aging, it is thought that the system will be applied in practice. Control of cerebral blood flow and synapse, which decreases with advanced age and hypertension, continues. In addition to slowing down in mental functions such as memory and learning, it progresses and accelerates in the sense of vibration, nerve velocity, proprioceptor feedback under skin receptor control, and can occur in static, dynamic and isokinetic muscle strength. This causes you to continue the preparations for the necessary evaluations in your postural stability and you watch.
Hypertension is defined as a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg or more. The sudden decrease in blood flow as a result of sudden changes in blood pressure in Hypertension effects the mechanism in the control of postural balance.
Although there are studies to understand the relationship of hypertension with postural control and consequently the risk of falling, further studies are needed.
Current literature has reported that the balance program, which was developed to improve balance, especially in geriatric individuals, is effective. In this sense, the Otago Protocol: The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. The Otago Workout Program includes five strengthening exercises and 12 balance exercises. Participants are asked to do the exercises three times a week (starting with 10 repetitions). In addition, participants are asked to walk for 30 minutes 2 times a week (walking can be divided into days). Depending on the individual's strength and mobility, exercises can be advanced. It should be applied 3 times a week for an average of 1 hour.
The purpose of this goal is to test in Otago educational work on static and dynamic movements, lower hypertensive muscle work, capacity and capacity and competence.
Method Evaluation parameters Demographic Information Variables such as age, gender, height, weight, body mass index (BMI), dominant side, duration of education, medications used, pain, how long the symptoms are present if there is pain, exercise habits, and how long they sit during the day. will be saved.
Standardized Mini Mental Test It is a scale that can be applied easily and gives information about the degree of cognitive impairment. This test consists of subsections that assess orientation, registration, attention, calculation, recall, language tests, and configuration. The highest score that can be obtained from the test is 30 .
Muscle strength measurement of lower extremity The muscles of hip, knee and ankle circumference will be measured with a hand held digital dynamometer.
FAB-T balance survey This scale evaluates both the dynamic and static balance of the individual who will participate in the study with 10 questions in it, it is a balance test with a total of 40 points. If the participant achieves a score below 25 points, it indicates that the risk of falling is high. The Turkish reliability and validity study was conducted in May 2020 Posture Evaluation will be evaluated by the photography method.
Functional capacity:
To determine it, the participating individuals were asked to travel as far as they could walk for 6 minutes. Before the test, blood pressure, oxygen saturation, heart rate, walking distance, shortness of breath and fatigue level according to borg were evaluated. Immediately after the test, recovery (5 minutes later), the same values will be recorded again.
One-leg stand test (static balance) While the patient's eyes are open, hands on hips, feet are bare, and the hip is in a neutral position, care is taken to flex one knee and not to touch the flexed foot during the test. The time starts as soon as the foot is lifted from the ground and is recorded in seconds. 3 attempts are made for each foot and the best value is recorded.
Timed Sit and Stand Test:
The individual is asked to sit in a chair with back support with arms in front of the body and stand up. During the test, how long the individual sits and stands for 30 seconds is recorded. A score less than 10 indicates lower extremity weakness.
Timed Get Up and Walk Test: While the individual is sitting in a supported chair, he is asked to stand up and walk 3 meters and sit down again, and the time is recorded. A healthy individual is expected to complete it in 12 seconds.
International Survey of Physical Activity (IPAQ) It was developed to determine the physical activity levels of participants between the ages of 15-65. The validity and reliability study of IPAQ in Turkey (2005). Walking is the structure that separates the scores of moderate-intensity activities and vigorous activities. Walking requires knowing the duration (minutes) and frequency (days) of moderate activities and vigorous activities to calculate the total score. A score is obtained as "MET minute/week" by multiplying the minute, day and MET value. Physical activity levels; classified as low (<600 MET - min/week), moderate (600 - 3000 MET - min/week) and high (beneficial for health) (>3000 MET - min/week)(19)
Foot Function Index:
Foot function index; It consists of 23 items with 3 main subgroups as pain, disability and activity limitation. While the nine-item pain subscale measures the level of foot pain in various situations, the 9-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. The activity limitation sub-scale, which includes five items, evaluates the activity limitations due to foot problems. Patients score all items with the Visual Analogue Scale (VAS) considering their foot conditions in the last 7 days.
Fall Activity Scale: It is a scale that asks the participants about 10 daily functions ranging from 1 to 10, 1 'I trust a lot' and 10 'I don't trust at all'. It was developed by Merry E. et al. in 1990. Turkish reliability and validity study was performed in 2009.
Training group: The Otago Protocol: The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. The Otago Workout Program includes five strengthening exercises and 12 balance exercises. Participants are asked to do the exercises three times a week (starting with 10 repetitions). In addition, participants are asked to walk for 30 minutes 2 times a week (walking can be divided into days). Depending on the individual's strength and mobility, exercises can be advanced. For example, adding hand weights to weight-lifting exercises or increasing repetitions. It should be applied 3 times a week for an average of 1 hour.
The training will last for 8 weeks and the evaluations will be evaluated before and after the training to determine the effectiveness of the training.
- Conditions
- Hypertension and Balance
- Being tested
- Functional exersize, Aerobic exersize
- Keywords
- hypertension, balance, aerobic, otago
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional exersizeOther
Participants will be given balance and strengthening exercises covering the balance exercise protocol.
Aerobic exersizeOther
60% of the maximum heart rate is given 3 walking eccentricity per week
| Study group | Role | What they receive |
|---|---|---|
| Functional exercise group and aerobic group | Experimental | Along with functional exercises, aerobic exercises (walking) 3 per week were given. Receives: Other: Functional exersize |
| Aerobic Exersize Group | Active comparator | aerobic exercises (walking) 3 per week were given. Receives: Other: Functional exersize; Other: Aerobic exersize |
| Control Group | No intervention | They continued their daily routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAB-T balance survey
This scale evaluates both the dynamic and static balance of the individual who will participate in the study with 10 questions in it, it is a balance test with a total of 40 points. If the participant achieves a score below 25 points, it indicates that the risk of falling is high. The Turkish reliability and validity study was conducted by Iyigun et al. in May 2020 (15)
Measured: 10 minutes
Secondary outcomes (1)
Lower working muscle strength
The hip value and the muscles to be evaluated will be measured with a hand-held digital dynamometer.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start28 Jun 2022
- Primary completion20 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension and BalanceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Necati Özler, Msc, Principal investigator, nozler@eul.emu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187702
- Sponsor's protocol ID
- Exercise in Hypertension
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2021
- Last updated
- 26 Jan 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Exercise Training on Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05187702
- Acronym / sponsor ID
- Exercise in Hypertension
- Conditions
- Hypertension and Balance
- Keywords
- hypertension, balance, aerobic, otago
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Jan 2022 (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.
It is the ability to keep and maintain the body training balance control center. Dynamic balance is the ability to maintain an individual's static position while the movement and posture are active while static. With aging, it is thought that the system will be applied in practice. Control of cerebral blood flow and synapse, which decreases with advanced age and hypertension, continues. In addition to slowing down in mental functions such as memory and learning, it progresses and accelerates in the sense of vibration, nerve velocity, proprioceptor feedback under skin receptor control, and can occur in static, dynamic and isokinetic muscle strength. This causes you to continue the preparations for the necessary evaluations in your postural stability and you watch. Particularly geriatrics reported that Otogo supports us to improve balance in us.
The purpose of this goal is to test in otago educational work on static and dynamic movements, lower hypertensive muscle work, capacity and capacity and competence.
Detailed description
It is the ability to keep and maintain the body training balance control. Dynamic balance is the ability to maintain an individual's static position while the movement and posture are active while static. With aging, it is thought that the system will be applied in practice. Control of cerebral blood flow and synapse, which decreases with advanced age and hypertension, continues. In addition to slowing down in mental functions such as memory and learning, it progresses and accelerates in the sense of vibration, nerve velocity, proprioceptor feedback under skin receptor control, and can occur in static, dynamic and isokinetic muscle strength. This causes you to continue the preparations for the necessary evaluations in your postural stability and you watch.
Hypertension is defined as a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg or more. The sudden decrease in blood flow as a result of sudden changes in blood pressure in Hypertension effects the mechanism in the control of postural balance.
Although there are studies to understand the relationship of hypertension with postural control and consequently the risk of falling, further studies are needed.
Current literature has reported that the balance program, which was developed to improve balance, especially in geriatric individuals, is effective. In this sense, the Otago Protocol: The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. The Otago Workout Program includes five strengthening exercises and 12 balance exercises. Participants are asked to do the exercises three times a week (starting with 10 repetitions). In addition, participants are asked to walk for 30 minutes 2 times a week (walking can be divided into days). Depending on the individual's strength and mobility, exercises can be advanced. It should be applied 3 times a week for an average of 1 hour.
The purpose of this goal is to test in Otago educational work on static and dynamic movements, lower hypertensive muscle work, capacity and capacity and competence.
Method Evaluation parameters Demographic Information Variables such as age, gender, height, weight, body mass index (BMI), dominant side, duration of education, medications used, pain, how long the symptoms are present if there is pain, exercise habits, and how long they sit during the day. will be saved.
Standardized Mini Mental Test It is a scale that can be applied easily and gives information about the degree of cognitive impairment. This test consists of subsections that assess orientation, registration, attention, calculation, recall, language tests, and configuration. The highest score that can be obtained from the test is 30 .
Muscle strength measurement of lower extremity The muscles of hip, knee and ankle circumference will be measured with a hand held digital dynamometer.
FAB-T balance survey This scale evaluates both the dynamic and static balance of the individual who will participate in the study with 10 questions in it, it is a balance test with a total of 40 points. If the participant achieves a score below 25 points, it indicates that the risk of falling is high. The Turkish reliability and validity study was conducted in May 2020 Posture Evaluation will be evaluated by the photography method.
Functional capacity:
To determine it, the participating individuals were asked to travel as far as they could walk for 6 minutes. Before the test, blood pressure, oxygen saturation, heart rate, walking distance, shortness of breath and fatigue level according to borg were evaluated. Immediately after the test, recovery (5 minutes later), the same values will be recorded again.
One-leg stand test (static balance) While the patient's eyes are open, hands on hips, feet are bare, and the hip is in a neutral position, care is taken to flex one knee and not to touch the flexed foot during the test. The time starts as soon as the foot is lifted from the ground and is recorded in seconds. 3 attempts are made for each foot and the best value is recorded.
Timed Sit and Stand Test:
The individual is asked to sit in a chair with back support with arms in front of the body and stand up. During the test, how long the individual sits and stands for 30 seconds is recorded. A score less than 10 indicates lower extremity weakness.
Timed Get Up and Walk Test: While the individual is sitting in a supported chair, he is asked to stand up and walk 3 meters and sit down again, and the time is recorded. A healthy individual is expected to complete it in 12 seconds.
International Survey of Physical Activity (IPAQ) It was developed to determine the physical activity levels of participants between the ages of 15-65. The validity and reliability study of IPAQ in Turkey (2005). Walking is the structure that separates the scores of moderate-intensity activities and vigorous activities. Walking requires knowing the duration (minutes) and frequency (days) of moderate activities and vigorous activities to calculate the total score. A score is obtained as "MET minute/week" by multiplying the minute, day and MET value. Physical activity levels; classified as low (<600 MET - min/week), moderate (600 - 3000 MET - min/week) and high (beneficial for health) (>3000 MET - min/week)(19)
Foot Function Index:
Foot function index; It consists of 23 items with 3 main subgroups as pain, disability and activity limitation. While the nine-item pain subscale measures the level of foot pain in various situations, the 9-item disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. The activity limitation sub-scale, which includes five items, evaluates the activity limitations due to foot problems. Patients score all items with the Visual Analogue Scale (VAS) considering their foot conditions in the last 7 days.
Fall Activity Scale: It is a scale that asks the participants about 10 daily functions ranging from 1 to 10, 1 'I trust a lot' and 10 'I don't trust at all'. It was developed by Merry E. et al. in 1990. Turkish reliability and validity study was performed in 2009.
Training group: The Otago Protocol: The Otago Exercise Program is an evidence-based, home-based, individually tailored strength and balance retraining program. The Otago Workout Program includes five strengthening exercises and 12 balance exercises. Participants are asked to do the exercises three times a week (starting with 10 repetitions). In addition, participants are asked to walk for 30 minutes 2 times a week (walking can be divided into days). Depending on the individual's strength and mobility, exercises can be advanced. For example, adding hand weights to weight-lifting exercises or increasing repetitions. It should be applied 3 times a week for an average of 1 hour.
The training will last for 8 weeks and the evaluations will be evaluated before and after the training to determine the effectiveness of the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional exercise group and aerobic group | Experimental | Other: Functional exersizeAlong with functional exercises, aerobic exercises (walking) 3 per week were given. |
| Aerobic Exersize Group | Active comparator | Other: Functional exersize, Other: Aerobic exersizeaerobic exercises (walking) 3 per week were given. |
| Control Group | No intervention | –They continued their daily routine |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals diagnosed with HT (at least 6 months),
- Individuals who are independent in activities of daily living,
Key exclusion criteria (2 listed)
- Those with neurological disease
- Those with Anxiety, Uncontrollable Hypertension, Chronic systemic disease
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 |
|---|---|---|
| Functional exersizeParticipants will be given balance and strengthening exercises covering the balance exercise protocol. | Other | Aerobic Exersize Group, Functional exercise group and aerobic group |
| Aerobic exersize60% of the maximum heart rate is given 3 walking eccentricity per week | Other | Aerobic Exersize Group |
Primary outcome
FAB-T balance survey
Time frame: 10 minutes
This scale evaluates both the dynamic and static balance of the individual who will participate in the study with 10 questions in it, it is a balance test with a total of 40 points. If the participant achieves a score below 25 points, it indicates that the risk of falling is high. The Turkish reliability and validity study was conducted by Iyigun et al. in May 2020 (15)
1 secondary outcome
Lower working muscle strength
Time frame: 15 minutes
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 26 Jan 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.
Necati Özler, Msc principal investigator
nozler@eul.emu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional exersize and Aerobic exersize in people with Hypertension and Balance, run by Eastern Mediterranean University at 1 site in Cyprus.
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 2 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 26 Jan 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 Cyprus. 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?
FAB-T balance survey (time frame: 10 minutes). 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 26 Jan 2023.