FMDNCT04199949
Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
A study testing Inactivity in people with FMD, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. 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
- FMD
- What is being tested?
- Inactivity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 1 Mar 2020
- 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
- Non-smoking
- Males
- Age (18-35 years old)
- Body mass index (BMI) of 18-27 kg/m2
- Recreationally active
- Ability to give informed consent
Who cannot join
- Smoking
- Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
- Clinically significant abnormalities on screening including ECG abnormalities
- Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
- Well-trained individuals
- On an energy-restricted diet or seeking to lose weight
- High alcohol consumption (<3-4 units/day)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.
- Conditions
- FMD
- Being tested
- Inactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InactivityBehavioural
On days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 5 consecutive days of normal daily levels of physical activity and matched food intake |
| Inactivity | Experimental | 5 consecutive days of reduced step count by 80% compared to the Control trial, whilst placing the non-dominant arm in a sling, and reduced food intake (~ 20%) to match the reduction in energy expenditure induced by inactivity Receives: Behavioral: Inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes
Measured: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery
The FMD of the popliteal artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes
Measured: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
Secondary outcomes (1)
Hand grip strength
The hand grip strength will be measured using a hand dynamometer. Three maximum hand grips separated by one minute rest at the end of each visit.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FMDStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moira Taylor, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199949
- Sponsor's protocol ID
- A90355
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2019
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
- ClinicalTrials.gov ID
- NCT04199949
- Acronym / sponsor ID
- A90355
- Conditions
- FMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Dec 2019 (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.
Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –5 consecutive days of normal daily levels of physical activity and matched food intake |
| Inactivity | Experimental | Behavioral: Inactivity5 consecutive days of reduced step count by 80% compared to the Control trial, whilst placing the non-dominant arm in a sling, and reduced food intake (~ 20%) to match the reduction in energy expenditure induced by inactivity |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking
- Males
- Age (18-35 years old)
- Body mass index (BMI) of 18-27 kg/m2
- Recreationally active
Key exclusion criteria (7 listed)
- Smoking
- Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
- Clinically significant abnormalities on screening including ECG abnormalities
- Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
- Well-trained individuals
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 |
|---|---|---|
| InactivityOn days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer. | Behavioural | Inactivity |
Primary outcome
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery
Time frame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes
Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery
Time frame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
The FMD of the popliteal artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes
1 secondary outcome
Hand grip strength
Time frame: 3 minutes
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 23 Feb 2022.
- Individual participant dataSharing planned: No
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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 Inactivity in people with FMD, run by University of Nottingham 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 6 inclusion and 7 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 23 Feb 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 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?
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery (time frame: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm). The study lists 2 primary outcomes in all. 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 23 Feb 2022.