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

Hypertension Clinical Trial

— POTENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069443
• Other study ID #: POTENT
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 120 Years

Eligibility

Inclusion Criteria:

1. Age +50 years old

2. 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:

1. Manifest cardiovascular disease (cerebrovascular disease, Heart failure, Chronic Kidney Disease, peripheral vascular disease, and advanced retinopathy (fundus hypertonus III-IV)).

2. Diabetes (any type)

3. More than three blood pressure regulating agents

4. Physical limitation preventing IHG training (e.g. missing an arm or musculoskeletal disorders).

5. Arthritis in the hand or carpal tunnel

6. SBP = 180 mmHg (will be advised to see a doctor)

Related Conditions & MeSH terms

• Hypertension
• Hypotension

Intervention

Other:
• IHG home training
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.

Locations

Country	Name	City	State
Denmark	Aalborg University hospital	Aalborg	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg University, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	after 20 weeks of training
Secondary	Diastolic blood pressure	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	after 20 weeks of training
Secondary	heart rate	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	after 20 weeks of training
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Systolic blood pressure	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	week 25, 35, and 40 post-intervention
Secondary	Diastolic blood pressure	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	week 25, 35, and 40 post-intervention
Secondary	heart rate	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)	week 25, 35, and 40 post-intervention