Aalborg University hospital
Aalborg, Danmark, 9000, Denmark
NCT Number: NCT03069443
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.
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Notify Me50 year–120 year
All sexes
Interventional
Not applicable
Aalborg, Danmark, 9000, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time frame: after 20 weeks of training
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time frame: baseline, 5 week, 15 weeks, and 20 weeks followup
This will be measured using the WII and reported in kilograms in the FysioMeter software
Time frame: baseline, 5 week, 15 weeks, and 20 weeks followup
measured using a specially designed software working together with a standard wii board.
Time frame: after 20 weeks of training
This will be a measure of the muscle force variability during the isometric training sessions throughout the study
Time frame: after 20 weeks of training
At the end of each training session. Pain will be assessed for each hand/side using the VAS scale
Time frame: after 20 weeks of training
A report will be generated on how many sessions each participant have completed during the study
Time frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Time frame: week 25, 35, and 40 post-intervention
measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)
Aalborg University Hospital
Other
Isometric Handgrip Home Training to Lower Blood Pressure in Hypertensive Older adulTs: a 20-week Assessor-blindEd raNdomized Controlled Trial
Acronym: POTENT
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