GlucoseNCT06704126
Does Passive Movement Increase Glucose Uptake Into Muscle?
A study testing Passive movement and Passive movement with blood flow restriction in people with Glucose and Insulin, run by Lancaster University at 1 site in United Kingdom.
Trial summary
This study aims to examine the blood sugar response after a meal, and how three different movement protocols may impact the blood sugar level. Participants will visit the lab on three different occasions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose, Insulin, Blood Flow Restriction Therapy
- What is being tested?
- Passive movement and Passive movement with blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2024to 11 Jul 2025
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old, inclusive
- Male
- Healthy (no known long-term health conditions / acute febrile illness)
Who cannot join
- Smokers
- Recent blood donation (within 12 weeks)
- Any medication
- Phobia of needles
- Blood pressure ≥ 140/90 mmHg, either figure
- Any potential atrial fibrillation or cardiovascular health conditions
- Diabetes
- Allergies to barley, gluten, nuts, almonds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Crossover Study of Passive Movement Training, With and Without Blood Flow Restriction, to Examine Postprandial Blood Glucose Levels
This study aims to examine the blood sugar response after a meal, and how three different movement protocols may impact the blood sugar level.
Participants will visit the lab on three different occasions. Before each visit the participant will eat a meal we give them and have a cannula (a needle with a tube) put in their arm to allow blood sampling for the visit.
Visit A will be the participant just having their legs moved by the machine, visit B will be the participant having their legs moved by the machine with the addition of blood pressure cuffs on their thighs, and visit C will just be the participant sitting still on the machine.
Read the detailed description
This study will require nine participants to be recruited and enrolled. The aim of the study is to determine the effect of passive movement, with and without blood flow restriction, on blood glucose and insulin primarily. Other outcomes included elsewhere in this registration. The protocol will involve an initial health screening/familiarisation session in the Human Performance Laboratory (HPL) at Lancaster University, followed by three randomly ordered HPL visits per participant. At the beginning of each HPL visit, the participant will be given a standard meal. The design is a crossover study therefore each participant will complete visits A, B and C and act as their own control.
Each of the visits A, B and C will involve consumption of a meal (86g carbohydrate content) and insertion of a cannula to the arm. Blood samples will then be drawn from the cannula at five minute intervals for approximately 3.5 hours. Three gold-top vacutainers will be taken throughout each visit to allow for insulin analysis. Once the blood is sampled, the vacutainer will be left to clot at room temperature for 15 minutes and then spun in a centrifuge at 4°C, 1800 RCF, for 10 minutes. The supernatant will be transferred to a microfuge tube via pipetting and stored at -80°C until analysis at a future date using an enzyme-linked immunosorbent assay (ELISA). In addition, 1ml syringe blood samples will be taken every 5 minutes and ejected onto a non-absorbent pad. A fraction of this ejection on the pad will then drawn up into a capillary tube to be analysed by a Biosen benchtop glucose/lactate analyser.
Visit A will invole the participant sitting on a Biodex isokinetic dynamometer and having both legs passively flexed and extended through 90 degrees, at a frequency of 1Hz for 30 minutes. This will be 60 seconds on, followed by 60 seconds off, repeated 15 times.
Visit B will involve the same as visit A, but with the addition of blood flow restriction intermittently. These are blood pressure bands (VALD AirBands) around the thighs which will inflate and deflate to cause 80% arterial occlusion in their inflated state. These will inflate and deflate in tandem with the passive movement going on and off.
Visit C is a control visit and will involve the participant sitting in the Biodex only with no movement or blood flow restriction occuring.
Throughout the study, measurements will be taken to meausure the outcome measure specified in this registration.
- Conditions
- Glucose, Insulin, Blood Flow Restriction Therapy, Blood Flow Velocity
- Being tested
- Passive movement, Passive movement with blood flow restriction
- Keywords
- Passive movement training, Blood flow restriction, Glucose, Insulin, Passive movement
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive movementOther
This study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes.
Passive movement with blood flow restrictionOther
This study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes. During the 60 seconds on of passive movement training, blood flow restriction cuffs which will be applied to the legs, will be inflated to cause 80% arterial blood flow occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Passive movement only | Experimental | Participants undergo passive movement training only Receives: Other: Passive movement |
| Passive movement + intermittent blood flow restriction | Experimental | Participants undergo passive movement training with blood flow restriction applied intermittently during the passive movement protocol Receives: Other: Passive movement with blood flow restriction |
| Control | No intervention | Sitting still in Biodex only - no movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Obtained by 5 minute interval blood draws from cannula then drawn up by a capillary tube and analysed by Biosen benchtop analyser
Measured: From pre-meal, every 5 minutes for 150 minutes
Secondary outcomes (4)
Blood insulin level
Obtained by gold-top vacutainer blood draw
Measured: Immediately pre-meal, 30 minutes post-meal and 60 minutes post-meal
Blood lactate level
Obtained by 5 minute interval blood draws from cannula then drawn up by a capillary tube and analysed by Biosen benchtop analyser
Measured: From pre-meal, every 5 minutes for 150 minutes
Femoral arterial blood velocity
Obtained pulse speed via ultrasound doppler
Measured: Measured at 0, 1, 5, 10, 20 and 30 minutes relative to the movement/control protocol commencing
Electromyography
Electromyography used to obtain magnitude of voluntary muscle contraction, sensor placed at 80% on the line between the anterior spina iliaca superior and the joint space in front of the anterior border of the medial ligament with perpendicular orientation as per Seniam guidance
Measured: Measured for 30 minutes beginning from movement/control protocol commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlucoseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Hendrickse, Lancaster University
- Investigators
- Paul Hendrickse, PhD, Principal investigator, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704126
- Sponsor's protocol ID
- FHM-2024-4434-SA-2
- Status last verified
- Aug 2025
- First submitted
- 19 Nov 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No benefit to sharing these data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study of Passive Movement Training, With and Without Blood Flow Restriction, to Examine Postprandial Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT06704126
- Acronym / sponsor ID
- FHM-2024-4434-SA-2
- Conditions
- Glucose, Insulin, Blood Flow Restriction Therapy, Blood Flow Velocity
- Keywords
- Passive movement training, Blood flow restriction, Glucose, Insulin, Passive movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 25 Nov 2024 (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 examine the blood sugar response after a meal, and how three different movement protocols may impact the blood sugar level.
Participants will visit the lab on three different occasions. Before each visit the participant will eat a meal we give them and have a cannula (a needle with a tube) put in their arm to allow blood sampling for the visit.
Visit A will be the participant just having their legs moved by the machine, visit B will be the participant having their legs moved by the machine with the addition of blood pressure cuffs on their thighs, and visit C will just be the participant sitting still on the machine.
Detailed description
This study will require nine participants to be recruited and enrolled. The aim of the study is to determine the effect of passive movement, with and without blood flow restriction, on blood glucose and insulin primarily. Other outcomes included elsewhere in this registration. The protocol will involve an initial health screening/familiarisation session in the Human Performance Laboratory (HPL) at Lancaster University, followed by three randomly ordered HPL visits per participant. At the beginning of each HPL visit, the participant will be given a standard meal. The design is a crossover study therefore each participant will complete visits A, B and C and act as their own control.
Each of the visits A, B and C will involve consumption of a meal (86g carbohydrate content) and insertion of a cannula to the arm. Blood samples will then be drawn from the cannula at five minute intervals for approximately 3.5 hours. Three gold-top vacutainers will be taken throughout each visit to allow for insulin analysis. Once the blood is sampled, the vacutainer will be left to clot at room temperature for 15 minutes and then spun in a centrifuge at 4°C, 1800 RCF, for 10 minutes. The supernatant will be transferred to a microfuge tube via pipetting and stored at -80°C until analysis at a future date using an enzyme-linked immunosorbent assay (ELISA). In addition, 1ml syringe blood samples will be taken every 5 minutes and ejected onto a non-absorbent pad. A fraction of this ejection on the pad will then drawn up into a capillary tube to be analysed by a Biosen benchtop glucose/lactate analyser.
Visit A will invole the participant sitting on a Biodex isokinetic dynamometer and having both legs passively flexed and extended through 90 degrees, at a frequency of 1Hz for 30 minutes. This will be 60 seconds on, followed by 60 seconds off, repeated 15 times.
Visit B will involve the same as visit A, but with the addition of blood flow restriction intermittently. These are blood pressure bands (VALD AirBands) around the thighs which will inflate and deflate to cause 80% arterial occlusion in their inflated state. These will inflate and deflate in tandem with the passive movement going on and off.
Visit C is a control visit and will involve the participant sitting in the Biodex only with no movement or blood flow restriction occuring.
Throughout the study, measurements will be taken to meausure the outcome measure specified in this registration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive movement only | Experimental | Other: Passive movementParticipants undergo passive movement training only |
| Passive movement + intermittent blood flow restriction | Experimental | Other: Passive movement with blood flow restrictionParticipants undergo passive movement training with blood flow restriction applied intermittently during the passive movement protocol |
| Control | No intervention | –Sitting still in Biodex only - no movement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-35 years old, inclusive
- Male
- Healthy (no known long-term health conditions / acute febrile illness)
Key exclusion criteria (8 listed)
- Smokers
- Recent blood donation (within 12 weeks)
- Any medication
- Phobia of needles
- Blood pressure ≥ 140/90 mmHg, either figure
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 |
|---|---|---|
| Passive movementThis study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes. | Other | Passive movement only |
| Passive movement with blood flow restrictionThis study will use a passive movement protocol delivered on a Biodex isokinetic dynamometer at 1Hz for 60 seconds on, 60 seconds off, for a total of 30 minutes. During the 60 seconds on of passive movement training, blood flow restriction cuffs which will be applied to the legs, will be inflated to cause 80% arterial blood flow occlusion. | Other | Passive movement + intermittent blood flow restriction |
Primary outcome
Blood glucose level
Time frame: From pre-meal, every 5 minutes for 150 minutes
Obtained by 5 minute interval blood draws from cannula then drawn up by a capillary tube and analysed by Biosen benchtop analyser
4 secondary outcomes
Blood insulin level
Time frame: Immediately pre-meal, 30 minutes post-meal and 60 minutes post-meal
Blood lactate level
Time frame: From pre-meal, every 5 minutes for 150 minutes
Femoral arterial blood velocity
Time frame: Measured at 0, 1, 5, 10, 20 and 30 minutes relative to the movement/control protocol commencing
Electromyography
Time frame: Measured for 30 minutes beginning from movement/control protocol commencement
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 11 Aug 2025.
- Individual participant dataSharing planned: No. No benefit to sharing these data.
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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.
Paul Hendrickse, PhD principal investigator
Lancaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive movement and Passive movement with blood flow restriction in people with Glucose and Insulin, run by Lancaster University at 1 site in United Kingdom.
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 8 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 11 Aug 2025. 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 Kingdom. 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?
Blood glucose level (time frame: From pre-meal, every 5 minutes for 150 minutes). 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 11 Aug 2025.