HypertensionTRiHYPNCT02705911
TeleRehabilitation in Hypertension
A study testing Isometric handgrip exercise and Aerobic endurance training in people with Hypertension and Pre-hypertension, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations. II. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pre-hypertension, Healthy
- What is being tested?
- Isometric handgrip exercise and Aerobic endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not physically active (< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013) will be recruited through advertisements. The latter is defined as:
- >115 mmHg < systolic BP < 139 mmHg and/or 75 mmHg< diastolic BP<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
- 139 mmHg < systolic BP < 160 mmHg and/or 90 mmHg<DBP< 100 mmHg in the absence of other cardiovascular risk factors
Who cannot join
- current smoker
- pregnancy
- presence of other cardiovascular disease, pulmonary disease or metabolic disease
- inability to perform a standard exercise program due to mental/physical disability.
- use of antihypertensive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?
The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations.
II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up.
III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?
- Conditions
- Hypertension, Pre-hypertension, Healthy
- Being tested
- Isometric handgrip exercise, Aerobic endurance training
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric handgrip exerciseOther
Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;
Aerobic endurance trainingOther
To perform 150 minutes extra/week at moderate aerobic intensity
| Study group | Role | What they receive |
|---|---|---|
| Isometric Handgrip training | Experimental | Participants are asked to perform daily 4 x 2 minute contractions with alternating hands , separated with 1 minute rest period using a ZonaHealth device; Receives: Other: Isometric handgrip exercise |
| Aerobic endurance training | Active comparator | Participants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week Receives: Other: Aerobic endurance training |
| Control | No intervention | Participants are asked to continue with their daily routine and not to perform extra exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in office blood pressure at 8 weeks of follow-up
Measured: 8 weeks - 6 months
Secondary outcomes (1)
change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up
Measured: 8 weeks - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Principal investigator, Véronique Cornelissen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705911
- Sponsor's protocol ID
- 1502214N
- Acronym
- TRiHYP
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2016
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?
- ClinicalTrials.gov ID
- NCT02705911
- Acronym / sponsor ID
- TRiHYP / 1502214N
- Conditions
- Hypertension, Pre-hypertension, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations.
II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up.
III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip training | Experimental | Other: Isometric handgrip exerciseParticipants are asked to perform daily 4 x 2 minute contractions with alternating hands , separated with 1 minute rest period using a ZonaHealth device; |
| Aerobic endurance training | Active comparator | Other: Aerobic endurance trainingParticipants are asked to perform at least 150 minutes extra of moderate aerobic exercise per week |
| Control | No intervention | –Participants are asked to continue with their daily routine and not to perform extra exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- not physically active (< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013) will be recruited through advertisements. The latter is defined as:
- >115 mmHg < systolic BP < 139 mmHg and/or 75 mmHg< diastolic BP<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
- 139 mmHg < systolic BP < 160 mmHg and/or 90 mmHg<DBP< 100 mmHg in the absence of other cardiovascular risk factors
Key exclusion criteria (5 listed)
- current smoker
- pregnancy
- presence of other cardiovascular disease, pulmonary disease or metabolic disease
- inability to perform a standard exercise program due to mental/physical disability.
- use of antihypertensive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric handgrip exerciseParticipants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device; | Other | Isometric Handgrip training |
| Aerobic endurance trainingTo perform 150 minutes extra/week at moderate aerobic intensity | Other | Aerobic endurance training |
Primary outcome
change in office blood pressure at 8 weeks of follow-up
Time frame: 8 weeks - 6 months
1 secondary outcome
change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up
Time frame: 8 weeks - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric handgrip exercise and Aerobic endurance training in people with Hypertension and Pre-hypertension, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in office blood pressure at 8 weeks of follow-up (time frame: 8 weeks - 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.