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The antihypertensive effects of isometric handgrip versus aerobic exercise in elderly hypertensive patients

Status Approved

First Submitted Date

2018/07/17
Registered Date

2019/05/21
Last Updated Date

2019/05/02

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003957
Unique Protocol ID	2017-002
Public/Brief Title	Isometric handgrip exercise and blood pressure
Scientific Title	The antihypertensive effects of isometric handgrip versus aerobic exercise in elderly hypertensive patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2017-002
Approval Date	2017-04-12
Institutional Review Board Name	Institutional Review Board, Seoul Medical Center
Institutional Review Board Address	Seoul Medical Center 156 Sinnae-ro, Jungnang-gu, Seoul, Korea
Institutional Review Board Telephone	02-2276-7433
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sae Young Jae
Title	Professor
Telephone	+82-2-6490-2953
Affiliation	Seoul Medical Center
Address	Seoul Medical Center 156 Sinnae-ro, Jungnang-gu, Seoul, Korea
Contact Person for Public Queries
Name	Sae Young Jae
Title	Professor
Telephone	+82-2-6490-2953
Affiliation	Seoul Medical Center
Address	Seoul Medical Center 156 Sinnae-ro, Jungnang-gu, Seoul, Korea
Contact Person for Updating Information
Name	Sae Young Jae
Title	Professor
Telephone	+82-2-6490-2953
Affiliation	Seoul Medical Center
Address	Seoul Medical Center 156 Sinnae-ro, Jungnang-gu, Seoul, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-05-29 Actual
Target Number of Participant	60
Primary Completion Date	2017-09-29 , Actual
Study Completion Date	2017-10-31 , Actual
Name of Study	University of Seoul
Recruitment Status	Completed
Date of First Enrollment	2017-05-29 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	2016928101

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	University of Seoul
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Background: Isometric handgrip exercise (IHE) is an easy and accessible form of exercise for elderly hypertensive patients. Although the antihypertensive effects of IHE have been documented in both normotensive and prehypertensive populations, it remains unclear whether such findings also extend to elderly hypertensive patients and whether the magnitude of IHE-induced blood pressure reductions is comparable to that of aerobic exercise (AE), which is commonly recommended for blood pressure management. The aim of this study was to compare the antihypertensive effects of IHE versus AE on office, central and 24-h ambulatory blood pressures in elderly hypertensive patients. Methods: After initial screening of 109 volunteers, 60 eligible participants were randomized in one of the three group. We conducted a randomized controlled trial with a three-arm design. Sixty elderly hypertensive patients (mean age 69±6 years) were randomized to IHG training (n=18), AE training (n=21), or non-exercise control group (n=21) for 12 weeks. Bilateral IHG training was performed at 30% of maximal voluntary contraction using a digital handgrip device. AE training was performed brisk walking for 30-min at moderate intensity with 3 times per week. Resting office, central, and 24-h ambulatory blood pressures, arterial stiffness, heart rate variability, brachial artery flow-mediated vasodilation, carotid artery intima-median thickness, plasma nitric oxide, oxidative stress and antioxidant marker were obtained at baseline and after intervention. Results: Six patients dropped out during the 12 weeks intervention of which, one in the IHG group, two in the AE group and three in the control group. No group differences were found at baseline for any variable. Following 12 weeks, resting office blood pressures and 24h ambulatory SBP (ASBP) decreased in both IHG and AE groups (IHG: SBP 133.3±14.5 to 124.3±9.8mmHg (p=0.004), DBP 84.9±7.6 to 79.3±6.2mmHg (p=0.005), 24h ASBP; 122.4±11.8 to 116.1±7.1mmHg (p=0.001) ; AE: SBP 131.7±14.3 to 122.7±7.8 (p=0.022), DBP 78.6±6.1 to 75.8±4.47mmHg (p=0.037) 24h ASBP 18.7±7.6 to 114.6±5.8mmHg (p=0.001), without any improvement in the control group. Carotid-femoral pulse wave velocity, index of arterial stiffness, decreased in both IHG and AE groups (IHG; 10.9±2.3 to 9.9±2.1m/s, AE;1 0.5±2.0m/s to 9.5±1.6m/s) without any improvement in the control group(trial-by-time interaction effect p=0.003). Conclusion: These findings suggest that both IHG and AE training reduce resting office blood pressure, but only IHG training is effective in improving central and ambulatory blood pressures. Thus, IHG training can help hypertension control in elderly hypertensive patients.

Study Summary Information

Lay Summary

Background: Isometric handgrip exercise (IHE) is an easy and accessible form of exercise for elderly hypertensive patients. Although the antihypertensive effects of IHE have been documented in both normotensive and prehypertensive populations, it remains unclear whether such findings also extend to elderly hypertensive patients and whether the magnitude of IHE-induced blood pressure reductions is comparable to that of aerobic exercise (AE), which is commonly recommended for blood pressure management. The aim of this study was to compare the antihypertensive effects of IHE versus AE on office, central and 24-h ambulatory blood pressures in elderly hypertensive patients. 
Methods: After initial screening of 109 volunteers, 60 eligible participants were randomized in one of the three group. We conducted a randomized controlled trial with a three-arm design. Sixty elderly hypertensive patients (mean age 69±6 years) were randomized to IHG training (n=18), AE training (n=21), or non-exercise control group (n=21) for 12 weeks. Bilateral IHG training was performed at 30&#37; of maximal voluntary contraction using a digital handgrip device. AE training was performed brisk walking for 30-min at moderate intensity with 3 times per week. Resting office, central, and 24-h ambulatory blood pressures, arterial stiffness, heart rate variability, brachial artery flow-mediated vasodilation, carotid artery intima-median thickness, plasma nitric oxide, oxidative stress and antioxidant marker were obtained at baseline and after intervention. 
Results: Six patients dropped out during the 12 weeks intervention of which, one in the IHG group, two in the AE group and three in the control group. No group differences were found at baseline for any variable. Following 12 weeks, resting office blood pressures and 24h ambulatory SBP (ASBP) decreased in both IHG and AE groups (IHG: SBP 133.3±14.5 to 124.3±9.8mmHg (p=0.004), DBP 84.9±7.6 to 79.3±6.2mmHg (p=0.005), 24h ASBP; 122.4±11.8 to 116.1±7.1mmHg (p=0.001) ; AE: SBP 131.7±14.3 to 122.7±7.8 (p=0.022), DBP 78.6±6.1 to 75.8±4.47mmHg (p=0.037) 24h ASBP 18.7±7.6 to 114.6±5.8mmHg (p=0.001), without any improvement in the control group. Carotid-femoral pulse wave velocity, index of arterial stiffness, decreased in both IHG and AE groups (IHG; 10.9±2.3 to 9.9±2.1m/s, AE;1 0.5±2.0m/s to 9.5±1.6m/s) without any improvement in the control group(trial-by-time interaction effect p=0.003).
Conclusion: These findings suggest that both IHG and AE training reduce resting office blood pressure, but only IHG training is effective in improving central and ambulatory blood pressures. Thus, IHG training can help hypertension control in elderly hypertensive patients.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Behavioral
Intervention Description	Isometric handgrip exercise group : Bilateral IHG training was performed at 30% of maximal voluntary contraction using a digital handgrip device with 3 times per week for 12 weeks. Aerobic exercise group : Aerobic exercise was performed brisk walking for 30-min at moderate intensity with 3 times per week for 12 weeks. Control group : no-exercise treatment
Number of Arms	3
Arm 1	Arm Label Isometric handgrip exercise group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Isometric handgrip exercise group : Bilateral IHG training was performed at 30% of maximal voluntary contraction using a digital handgrip device with 3 times per week for 12 weeks.
Arm 2	Arm Label Aerobic exercise group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Aerobic exercise was performed brisk walking for 30-min at moderate intensity with 3 times per week for 12 weeks.
Arm 3	Arm Label Control group
	Target Number of Participant 20
	Arm Type No intervention
	Arm Description Maintaine general lifestyle without exercise treatment

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I10.9)Other and unspecified primary hypertension Hypertension
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 60Year~80Year
	Description Diagnosised hypertension by a doctor Current taking antihypertensive medications over the 4 months Patients who did not have regular exercise
Exclusion Criteria	Patients who were cardiovascular disease, Type 2 diabetes, inflammatory disease and pulmonary disease Patients with musclarskeletal problems who were not able to exercise Patients with resistance hypertension
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Resting blood pressure, 24-hours Ambulatory blood pressure
Timepoint	Baseline and post intervention
Secondary Outcome(s) 1
Outcome	Endothelial function, Arterial stiffness, Heart rate variablility
Timepoint	Baseline and post intervention

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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