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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: IHG home training

• Registration Number: NCT03069443
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-03-15
• Status Verified: 2020-07
• Primary Completion: 2020-07-09
• Study Completion: 2020-07-09
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IHG+Hypertension lifestyle guidelines	IHG home training	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	after 20 weeks of training	measured using a standard hospital electrical sphygmomanometer (Omron Comfort M6 AC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aalborg University hospital; 🇩🇰 Aalborg, Danmark, Denmark