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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Aalborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IHG+Hypertension lifestyle guidelines | Experimental | 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. |
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| Hypertension lifestyle guidelines | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IHG home training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC) | after 20 weeks of training |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University hospital | Aalborg | Danmark | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29426359 | Derived | Jorgensen MG, Ryg J, Danielsen MB, Madeleine P, Andersen S. Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial. Trials. 2018 Feb 9;19(1):97. doi: 10.1186/s13063-018-2441-x. |
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Data from the study will be made available on a public server
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |