Cardiovascular Responses in Elderly With Isolated Systolic HypertensionNCT02270216
Cardiovascular Responses to Static and Dynamic Exercise in Elderly With Isolated Systolic Hypertension
A study testing static hand grip exercise and cycling exercise in people with Cardiovascular Responses in Elderly With Isolated Systolic Hypertension, run by Sahachat Aueyingsak at 1 site in Thailand.
Trial summary
Aim to study the exercise responses to both static and dynamic exercise in elderly people with and without essential isolated systolic hypertension, seeking to identify potentially dangerously high responses Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Responses in Elderly With Isolated Systolic Hypertension
- What is being tested?
- static hand grip exercise and cycling exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Oct 2014
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history
Who cannot join
- Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Cardiovascular Responses to Static and Dynamic Exercise in Isolated Systolic Hypertension
Aim to study the exercise responses to both static and dynamic exercise in elderly people with and without essential isolated systolic hypertension, seeking to identify potentially dangerously high responses
Read the detailed description
- Design The proposed study is of a experimental study design. The study will be subject to approval by the Ethical committee of Khon Kaen University and subjects will be asked to give their written agreement to participate.
- Subjects Elderly subjects with isolated systolic hypertension will be recruited from primary care units in the community and outpatient department of Srinakarind hospital in Khon Kaen province. Healthy normotensive subjects living independently with normal physical activity will be recruited from the same community. Inclusion criteria: Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history Exclusion criteria: Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain Subjects who have passed the inclusion criteria and exclusion criteria will undertake a dynamic exercise test and a static hand-grip exercise pressor test in the cardiopulmonary research room , Khon Kaen University
- Outcome measurements The main outcome measures will be changes in blood pressure and heart rate during the two forms of exercise. Blood pressure: Blood pressure will be measured with a digital bedside monitor (Figure 1). An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes Heart rate: Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system.
- Procedures and protocol After an interview where they will be informed about the various tests and asked to provide their informed consent, the subjects will undertake two different exercise tests, the order of which will be in a randomized and balanced design. The subjects will be asked not to smoke, take alcohol or caffeinated drinks within 2 hours before testing. Cycling exercise: The dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age (Gellish et al., 2007) and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached. Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load. Static exercise pressor response: The static exercise pressor response will be tested using isometric handgrip of the left hand. The forearm will be supported on an arm rest with elbow flexed. The maximum voluntary contraction force will be measured as the best of three attempts. After 2 minute rest, subjects will perform 2 minute of isometric hand grip contraction at 30% MVC. Circulatory occlusion(50 mmHg supra-systolic pressure) will start at 1.30 min and continued for 2 minute after the end of the isometric handgrip exercise. Following release of the cuff there will be a further 2 minutes recovery. The blood pressure and heart rate will be measured at the end of each minute during rest, isometric handgrip, circulatory occlusion and recovery. Subjects will be instructed to breathe normally during the test and avoid any Valsalva maneuver; breathing frequency will be monitored during the handgrip pressor test using capnography.
- Data and statistical analysis Data will be expressed as mean ± SD. Changes of data during and post test from baseline. Will be tested by paired t-test. Significance were set at P<0.05.
- Being tested
- static hand grip exercise, cycling exercise
- Keywords
- isolated systolic hypertension, exercise pressor responses
- Medical subject headings
- Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
static hand grip exerciseProcedure or surgery
Also called static exercise
The static exercise pressor response will be tested using isometric handgrip of the left hand. The forearm will be supported on an arm rest with elbow flexed. The maximum voluntary contraction force will be measured as the best of three attempts. After 2 minute rest, subjects will perform 2 minute of isometric hand grip contraction at 30% MVC. Circulatory occlusion(50 mmHg supra-systolic pressure) will start at 1.30 min and continued for 2 minute after the end of the isometric handgrip exercise. Following release of the cuff there will be a further 2 minutes recovery. The blood pressure and heart rate will be measured at the end of each minute during rest, isometric handgrip, circulatory occlusion and recovery. Subjects will be instructed to breathe normally during the test and avoid any Valsalva maneuver; breathing frequency will be monitored during the handgrip pressor test using capnography.
cycling exerciseProcedure or surgery
The dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached.
Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load. At the end of the exercise, the subjects will sit for ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| elderly with isolated systolic hypertension | Active comparator | over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history Receives: Procedure: static hand grip exercise; Procedure: cycling exercise |
| healthy elderly | Active comparator | over 60 years of age with normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history Receives: Procedure: static hand grip exercise; Procedure: cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure will be measured with a digital bedside monitor. An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes
Measured: 6 month
heart rate
Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Responses in Elderly With Isolated Systolic HypertensionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahachat Aueyingsak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahachat Aueyingsak, Khon Kaen University
- Investigators
- Chulee Jones, PhD, Study chair, Faculty of Associated Medical Science, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270216
- Sponsor's protocol ID
- KhonKaenU
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cardiovascular Responses to Static and Dynamic Exercise in Isolated Systolic Hypertension
- ClinicalTrials.gov ID
- NCT02270216
- Acronym / sponsor ID
- KhonKaenU
- Keywords
- isolated systolic hypertension, exercise pressor responses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sahachat AueyingsakUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- 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.
Aim to study the exercise responses to both static and dynamic exercise in elderly people with and without essential isolated systolic hypertension, seeking to identify potentially dangerously high responses
Detailed description
- Design The proposed study is of a experimental study design. The study will be subject to approval by the Ethical committee of Khon Kaen University and subjects will be asked to give their written agreement to participate.
- Subjects Elderly subjects with isolated systolic hypertension will be recruited from primary care units in the community and outpatient department of Srinakarind hospital in Khon Kaen province. Healthy normotensive subjects living independently with normal physical activity will be recruited from the same community. Inclusion criteria: Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history Exclusion criteria: Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain Subjects who have passed the inclusion criteria and exclusion criteria will undertake a dynamic exercise test and a static hand-grip exercise pressor test in the cardiopulmonary research room , Khon Kaen University
- Outcome measurements The main outcome measures will be changes in blood pressure and heart rate during the two forms of exercise. Blood pressure: Blood pressure will be measured with a digital bedside monitor (Figure 1). An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes Heart rate: Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system.
- Procedures and protocol After an interview where they will be informed about the various tests and asked to provide their informed consent, the subjects will undertake two different exercise tests, the order of which will be in a randomized and balanced design. The subjects will be asked not to smoke, take alcohol or caffeinated drinks within 2 hours before testing. Cycling exercise: The dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age (Gellish et al., 2007) and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached. Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load. Static exercise pressor response: The static exercise pressor response will be tested using isometric handgrip of the left hand. The forearm will be supported on an arm rest with elbow flexed. The maximum voluntary contraction force will be measured as the best of three attempts. After 2 minute rest, subjects will perform 2 minute of isometric hand grip contraction at 30% MVC. Circulatory occlusion(50 mmHg supra-systolic pressure) will start at 1.30 min and continued for 2 minute after the end of the isometric handgrip exercise. Following release of the cuff there will be a further 2 minutes recovery. The blood pressure and heart rate will be measured at the end of each minute during rest, isometric handgrip, circulatory occlusion and recovery. Subjects will be instructed to breathe normally during the test and avoid any Valsalva maneuver; breathing frequency will be monitored during the handgrip pressor test using capnography.
- Data and statistical analysis Data will be expressed as mean ± SD. Changes of data during and post test from baseline. Will be tested by paired t-test. Significance were set at P<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly with isolated systolic hypertension | Active comparator | Procedure: static hand grip exercise, Procedure: cycling exerciseover 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history |
| healthy elderly | Active comparator | Procedure: static hand grip exercise, Procedure: cycling exerciseover 60 years of age with normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history
Key exclusion criteria (1 listed)
- Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain
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 |
|---|---|---|
| static hand grip exerciseAlso: static exerciseThe static exercise pressor response will be tested using isometric handgrip of the left hand. The forearm will be supported on an arm rest with elbow flexed. The maximum voluntary contraction force will be measured as the best of three attempts. After 2 minute rest, subjects will perform 2 minute of isometric hand grip contraction at 30% MVC. Circulatory occlusion(50 mmHg supra-systolic pressure) will start at 1.30 min and continued for 2 minute after the end of the isometric handgrip exercise. Following release of the cuff there will be a further 2 minutes recovery. The blood pressure and heart rate will be measured at the end of each minute during rest, isometric handgrip, circulatory occlusion and recovery. Subjects will be instructed to breathe normally during the test and avoid any Valsalva maneuver; breathing frequency will be monitored during the handgrip pressor test using capnography. | Procedure or surgery | elderly with isolated systolic hypertension, healthy elderly |
| cycling exerciseThe dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached. Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load. At the end of the exercise, the subjects will sit for ten minutes. | Procedure or surgery | elderly with isolated systolic hypertension, healthy elderly |
Primary outcome
Blood pressure
Time frame: 6 month
Blood pressure will be measured with a digital bedside monitor. An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes
heart rate
Time frame: 6 month
Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- The seventh report of the joint national committee on prevention, Detection, evaluation, and treatment of high blood pressureLink provided by the sponsor.
- Update on pathophysiology and treatment of hypertension in the elderly.Link provided by the sponsor.
- Exaggerated sympathetic and pressor responses to handgrip exercise in older hypertensive humans: role of the muscle metaboreflexLink provided by the sponsor.
- Effect of muscle metaboreflex activation on carotid-cardiac baroreflex function in humansLink provided by the sponsor.
- The effectiveness of exercise training in lowering blood pressure: a meta-analysis of randomised controlled trials of 4 weeks or longerLink provided by the sponsor.
- Effects of aerobic training on exaggerated blood pressure response to exercise in African-Americans with severe systemic hypertension treated with indapamide +/- verapamil +/- enalaprilLink provided by the sponsor.
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.
Chulee Jones, PhD study chair
Faculty of Associated Medical Science, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing static hand grip exercise and cycling exercise in people with Cardiovascular Responses in Elderly With Isolated Systolic Hypertension, run by Sahachat Aueyingsak at 1 site in Thailand.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. 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 Thailand. 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?
Results are not available in the source record.
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?
Blood pressure (time frame: 6 month). The study lists 2 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 21 Oct 2014.