TeleRehabilitation in Hypertension

Healthy Clinical Trial

— TRiHYP  

Official title:

Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705911
• Other study ID #: 1502214N
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations. II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up. III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• not physically active (< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013)

will be recruited through advertisements. The latter is defined as:

• >115 mmHg < systolic BP < 139 mmHg and/or 75 mmHg< diastolic BP<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
• 139 mmHg < systolic BP < 160 mmHg and/or 90 mmHg<DBP< 100 mmHg in the absence of other cardiovascular risk factors

Exclusion Criteria:

• current smoker
• pregnancy
• presence of other cardiovascular disease, pulmonary disease or metabolic disease
• inability to perform a standard exercise program due to mental/physical disability.
• use of antihypertensive drugs

Related Conditions & MeSH terms

• Healthy
• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

Other:
• Isometric handgrip exercise
Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;
• Aerobic endurance training
To perform 150 minutes extra/week at moderate aerobic intensity

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in office blood pressure at 8 weeks of follow-up		8 weeks - 6 months
Secondary	change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up		8 weeks - 6 months