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Cardiovascular Responses to Static and Dynamic Exercise in Elderly With Isolated Systolic Hypertension

Primary Purpose

Cardiovascular Responses in Elderly With Isolated Systolic Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
static hand grip exercise
cycling exercise
Sponsored by
Sahachat Aueyingsak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Responses in Elderly With Isolated Systolic Hypertension focused on measuring isolated systolic hypertension, exercise pressor responses

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

elderly with isolated systolic hypertension

healthy elderly

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2014
Last Updated
October 17, 2014
Sponsor
Sahachat Aueyingsak
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1. Study Identification

Unique Protocol Identification Number
NCT02270216
Brief Title
Cardiovascular Responses to Static and Dynamic Exercise in Elderly With Isolated Systolic Hypertension
Official Title
Study of Cardiovascular Responses to Static and Dynamic Exercise in Isolated Systolic Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sahachat Aueyingsak

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Responses in Elderly With Isolated Systolic Hypertension
Keywords
isolated systolic hypertension, exercise pressor responses

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
elderly with isolated systolic hypertension
Arm Type
Active Comparator
Arm Description
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
Arm Title
healthy elderly
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
static hand grip exercise
Other Intervention Name(s)
static exercise
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
cycling exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
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
Time Frame
6 month
Title
heart rate
Description
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.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulee Jones, PhD
Organizational Affiliation
Faculty of Associated Medical Science, Khon Kaen University
Official's Role
Study Chair
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/14656957
Description
The seventh report of the joint national committee on prevention, Detection, evaluation, and treatment of high blood pressure
URL
http://www.ncbi.nlm.nih.gov/pubmed/21681384
Description
Update on pathophysiology and treatment of hypertension in the elderly.
URL
http://www.ncbi.nlm.nih.gov/pubmed/20802135
Description
Exaggerated sympathetic and pressor responses to handgrip exercise in older hypertensive humans: role of the muscle metaboreflex
URL
http://www.ncbi.nlm.nih.gov/pubmed/18326794
Description
Effect of muscle metaboreflex activation on carotid-cardiac baroreflex function in humans
URL
http://www.ncbi.nlm.nih.gov/pubmed/9400906
Description
The effectiveness of exercise training in lowering blood pressure: a meta-analysis of randomised controlled trials of 4 weeks or longer
URL
http://www.ncbi.nlm.nih.gov/pubmed/9165176
Description
Effects of aerobic training on exaggerated blood pressure response to exercise in African-Americans with severe systemic hypertension treated with indapamide +/- verapamil +/- enalapril
URL
http://www.ncbi.nlm.nih.gov/pubmed/20962429
Description
Aging and arterial stiffness
URL
http://www.ncbi.nlm.nih.gov/pubmed/21285661
Description
RESPeRATE: nonpharmacological treatment of hypertension.

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Cardiovascular Responses to Static and Dynamic Exercise in Elderly With Isolated Systolic Hypertension

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