NCT02270216

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

October 14, 2014

Last Update Submit

October 17, 2014

Conditions

Keywords

isolated systolic hypertensionexercise pressor responses

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    6 month

Study Arms (2)

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

Procedure: static hand grip exerciseProcedure: 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

Procedure: static hand grip exerciseProcedure: cycling exercise

Interventions

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.

Also known as: static exercise
elderly with isolated systolic hypertensionhealthy elderly

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.

elderly with isolated systolic hypertensionhealthy elderly

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40000, Thailand

Location

Related Links

MeSH Terms

Conditions

Isolated Systolic Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Essential HypertensionHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chulee Jones, PhD

    Faculty of Associated Medical Science, Khon Kaen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Degree Student

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 21, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations