Inactivity/Low Levels of ExerciseNCT07223645
Handgrip Training and Brain Blood Flow Regulation
A study testing Handgrip Training in people with Inactivity/Low Levels of Exercise, run by Florida State University at 1 site in United States.
Trial summary
This study aims to investigate the effect of isometric handgrip training on brain blood vessel function in physically inactive adults. Isometric handgrip training is a promising strategy for lowering blood pressure and improving vascular health, but no previous investigations have studied the effect of training on… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity/Low Levels of Exercise
- What is being tested?
- Handgrip Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 27 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 years old
- Body mass index ≤30 kg/m2 (without obesity)
- Physically inactive (not meeting the current recommendations of ≥150 minutes per week of moderate-to-vigorous aerobic exercise and not ≥2 days per week of resistance training) in last 6 months
- Have a smartphone and are willing to download mobile applications used in this project
Who cannot join
- Having an overt chronic condition (e.g., cardiovascular, cerebrovascular, etc.)
- Being pregnant, planning to become pregnant, or breastfeeding/lactating
- Regular use of nicotine products in the past 6 months
- Recent head injury/trauma or concussion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32306
Joseph Watso, PhD, 850-644-5260, jwatso@fsu.edu
About this study
This study aims to investigate the effect of isometric handgrip training on brain blood vessel function in physically inactive adults. Isometric handgrip training is a promising strategy for lowering blood pressure and improving vascular health, but no previous investigations have studied the effect of training on markers of brain blood vessel function. Based on previous work showing improvements in vascular function after isometric handgrip training, we hypothesize that isometric handgrip training will improve key markers of cerebrovascular function.
Read the detailed description
The incidence of cerebrovascular diseases is expected to increase. Early life sets the stage for vascular health outcomes later in life. Regular exercise is recommended for improving cerebrovascular health outcomes, but a lack of time or inadequate facilities are common exercise barriers. Not getting enough exercise is associated with worse cardiovascular and cerebrovascular health outcomes. There is a critical need for time-efficient strategies that require minimal equipment for improving cardiovascular and cerebrovascular health. Isometric handgrip (IHG) training is an effective strategy for improving cardiovascular health. Despite IHG's usefulness for improving vascular health through blood pressure reductions and improvements in endothelial function, almost nothing is known about IHG training and cerebrovascular function. Therefore, this project aims to test the hypothesis that 8 weeks of IHG training will improve cerebrovascular blood flow regulation and total cerebrovascular blood flow among adult humans who are not meeting the physical activity recommendations. We will measure middle cerebral artery blood velocity (MCAv) via transcranial Doppler ultrasound and assess MCAv dynamic autoregulation and MCAv reactivity to high and low carbon dioxide. We will also measure total cerebral blood flow, central artery stiffness, and MCAv pulsatility index. Understanding the effect of IHG on cerebrovascular health could inform exercise recommendations.
- Conditions
- Inactivity/Low Levels of Exercise
- Being tested
- Handgrip Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip TrainingDevice
Handgrip training 3 days per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Isometric Handgrip Training - Intervention | Experimental | Participants will perform moderate-intensity handgrip training three days per week for eight weeks using a handheld device. Receives: Device: Handgrip Training |
| Isometric Handgrip Training - Sham | Sham comparator | Participants will perform very low-intensity handgrip training three days per week for eight weeks using a handheld device. Receives: Device: Handgrip Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in middle cerebral artery blood velocity reactivity to hypercapnia
Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound
Measured: Up to 9 weeks
Secondary outcomes (6)
Change in middle cerebral artery blood velocity reactivity to hypocapnia
Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound
Measured: Up to 9 weeks
Brachial systolic blood pressure
Blood pressure measured at the brachial artery
Measured: Up to 9 weeks
Change in dynamic cerebral autoregulation phase
Calculated from middle cerebral artery blood velocity signal using transfer function analysis
Measured: Up to 9 weeks
Change in dynamic cerebral autoregulation gain
Calculated from middle cerebral artery blood velocity signal using transfer function analysis
Measured: Up to 9 weeks
Change in total resting brain blood flow
Total brain blood flow measured in the internal carotid and vertebral arteries at rest via ultrasound
Measured: Up to 9 weeks
Middle cerebral artery blood velocity pulsatility index
Calculated from middle cerebral artery blood velocity signal
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start27 Oct 2025
- Primary completion27 Oct 2027 (estimated)
- Study completion27 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactivity/Low Levels of ExerciseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223645
- Sponsor's protocol ID
- STUDY00006271
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handgrip Training and Brain Blood Flow Regulation
- ClinicalTrials.gov ID
- NCT07223645
- Acronym / sponsor ID
- STUDY00006271
- Conditions
- Inactivity/Low Levels of Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 27 Oct 2027 (estimated)
- Study completion
- 27 Oct 2028 (estimated)
- First posted
- 3 Nov 2025 (actual)
- 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.
This study aims to investigate the effect of isometric handgrip training on brain blood vessel function in physically inactive adults. Isometric handgrip training is a promising strategy for lowering blood pressure and improving vascular health, but no previous investigations have studied the effect of training on markers of brain blood vessel function. Based on previous work showing improvements in vascular function after isometric handgrip training, we hypothesize that isometric handgrip training will improve key markers of cerebrovascular function.
Detailed description
The incidence of cerebrovascular diseases is expected to increase. Early life sets the stage for vascular health outcomes later in life. Regular exercise is recommended for improving cerebrovascular health outcomes, but a lack of time or inadequate facilities are common exercise barriers. Not getting enough exercise is associated with worse cardiovascular and cerebrovascular health outcomes. There is a critical need for time-efficient strategies that require minimal equipment for improving cardiovascular and cerebrovascular health. Isometric handgrip (IHG) training is an effective strategy for improving cardiovascular health. Despite IHG's usefulness for improving vascular health through blood pressure reductions and improvements in endothelial function, almost nothing is known about IHG training and cerebrovascular function. Therefore, this project aims to test the hypothesis that 8 weeks of IHG training will improve cerebrovascular blood flow regulation and total cerebrovascular blood flow among adult humans who are not meeting the physical activity recommendations. We will measure middle cerebral artery blood velocity (MCAv) via transcranial Doppler ultrasound and assess MCAv dynamic autoregulation and MCAv reactivity to high and low carbon dioxide. We will also measure total cerebral blood flow, central artery stiffness, and MCAv pulsatility index. Understanding the effect of IHG on cerebrovascular health could inform exercise recommendations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip Training - Intervention | Experimental | Device: Handgrip TrainingParticipants will perform moderate-intensity handgrip training three days per week for eight weeks using a handheld device. |
| Isometric Handgrip Training - Sham | Sham comparator | Device: Handgrip TrainingParticipants will perform very low-intensity handgrip training three days per week for eight weeks using a handheld device. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 35 years old
- Body mass index ≤30 kg/m2 (without obesity)
- Physically inactive (not meeting the current recommendations of ≥150 minutes per week of moderate-to-vigorous aerobic exercise and not ≥2 days per week of resistance training) in last 6 months
- Have a smartphone and are willing to download mobile applications used in this project
Key exclusion criteria (4 listed)
- Having an overt chronic condition (e.g., cardiovascular, cerebrovascular, etc.)
- Being pregnant, planning to become pregnant, or breastfeeding/lactating
- Regular use of nicotine products in the past 6 months
- Recent head injury/trauma or concussion
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 |
|---|---|---|
| Handgrip TrainingHandgrip training 3 days per week for 8 weeks | Device | Isometric Handgrip Training - Intervention, Isometric Handgrip Training - Sham |
Primary outcome
Change in middle cerebral artery blood velocity reactivity to hypercapnia
Time frame: Up to 9 weeks
Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound
6 secondary outcomes
Change in middle cerebral artery blood velocity reactivity to hypocapnia
Time frame: Up to 9 weeks
Brachial systolic blood pressure
Time frame: Up to 9 weeks
Change in dynamic cerebral autoregulation phase
Time frame: Up to 9 weeks
Change in dynamic cerebral autoregulation gain
Time frame: Up to 9 weeks
Change in total resting brain blood flow
Time frame: Up to 9 weeks
Middle cerebral artery blood velocity pulsatility index
Time frame: Up to 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip Training in people with Inactivity/Low Levels of Exercise, run by Florida State University at 1 site in United States.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in middle cerebral artery blood velocity reactivity to hypercapnia (time frame: Up to 9 weeks). 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 7 Oct 2026.