Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs

Study Overview
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Brief Summary
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This Study evaluates the effect of 20 weeks of isometric handgrip (IHG) home training in adults aged 50 years or more. Half of the participants will serve as a control group and will only receive hypertension-guidelines on lifestyle changes.

Detailed Description
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Hypertension markedly increases the risk of cardiovascular diseases and overall mortality. Lifestyle modifications such as increased levels of physical activity are recommended as the ﬁrst line of anti-hypertensive treatment. A recent systematic review showed that isometric handgrip (IHG) training was superior to traditional endurance and strength training in lowering resting systolic blood pressure (SBP). The average length of previous IHG training studies is approximately 7.5 weeks with the longest being 10 weeks. Therefore, presently it is unknown if it is possible to further lower blood pressure levels beyond the 10 week mark. Recently, the investigators developed a novel method for monitoring handgrip intensity using a standard Nintendo Wii Board (Wii). The primary aim of this study is to explore the effects of 20-weeks IHG home training facilitated by a Wii in hypertensive older adults (+50 years of age) in lowering SBP compared to usual care. Secondary aims are to explore if/when a leveling off effect on SBP will occur during the 20-week intervention period in the training group and to explore adherence and potential harms related to the IHG home training. Methods: Based on previous evidence, the investigators calculated that 50 hypertensive older adults (+50 years of age) is needed to achieve a power of 80% or more. Participants will be randomly assigned to either an intervention group (IHG home training + hypertension-guidelines on lifestyle changes) or to a control group (hypertension-guidelines on lifestyle changes). Participants in the intervention group will perform IHG home training (30% of maximum grip strength for a total of 8 min per day per hand) three times a week for 20-weeks.

Official Title
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Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs: a 20-week Assessor-blindEd raNdomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Other: IHG home training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age +50 years old Un-medicated (anti-hypertensive medicine) with resting SBP between 135-179 mmHg or hypertensive patient medicated with no change in treatment for ≥ 4 months with resting SBP between 135-179 mmHg Exclusion Criteria: Manifest cardiovascular disease (cerebrovascular disease, Heart failure, Chronic Kidney Disease, peripheral vascular disease, and advanced retinopathy (fundus hypertonus III-IV)). Diabetes (any type) More than three blood pressure regulating agents Physical limitation preventing IHG training (e.g. missing an arm or musculoskeletal disorders). Arthritis in the hand or carpal tunnel SBP ≥ 180 mmHg (will be advised to see a doctor)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IHG+Hypertension lifestyle guidelines<br>Participants in this group will follow a home-based IHG training protocol. The IHG training will be structured with four sets of 2-minute contractions for each hand, 3 days per week for 20 weeks. In addition, the IHG group will receive information about hypertension-guidelines on lifestyle changes. | Other: IHG home training<br>* Participants of the intervention group will follow the IHG home training protocol for 20 weeks. The IHG training consists of isometric contractions applied with the hands on a Wii.<br>|
| No Intervention: Hypertension lifestyle guidelines<br>The usual care group will receive information about hypertension-guidelines on lifestyle changes. The usual care group will have the same amount of hospital visits for measurements of blood pressure and maximal muscle tests as the intervention group in order to ensure similar attention provided by the healthcare professionals. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | after 20 weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | after 20 weeks of training | 
| heart rate | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | after 20 weeks of training | 
| Handgrip maximum strength | This will be measured using the WII and reported in kilograms in the FysioMeter software | baseline, 5 week, 15 weeks, and 20 weeks followup | 
| Handgrip Rate of force development | measured using a specially designed software working together with a standard wii board. | baseline, 5 week, 15 weeks, and 20 weeks followup | 
| Handgrip Force variability | This will be a measure of the muscle force variability during the isometric training sessions throughout the study | after 20 weeks of training | 
| Visual Analog Pain Scale (VAS) | At the end of each training session. Pain will be assessed for each hand/side using the VAS scale | after 20 weeks of training | 
| Compliance to training sessions | A report will be generated on how many sessions each participant have completed during the study | after 20 weeks of training | 
| Systolic blood pressure | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | week 25, 35, and 40 post-intervention | 
| Diastolic blood pressure | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | week 25, 35, and 40 post-intervention | 
| heart rate | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | week 25, 35, and 40 post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isometric handgrip training, home training, older adults, Hypertension