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Endothelial DysfunctionNCT03087643

Passive Mobilization and Vascular Function

A study testing Passive mobilization - PM in people with Endothelial Dysfunction and Aging, run by Universita di Verona at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With aging, vascular function (VF) declines. Inactivity and sedentary life style have been shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used for the management of many chronic conditions, has been proven to lead to even more deleterious consequences, including VF decline. Read more about this study

Who is it for?
Ages 65 to 110 yearsHealthy volunteers can take part
Conditions the study is for
Endothelial Dysfunction, Aging, Bed Rest
What is being tested?
Passive mobilization - PM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
3 sitesItaly
Study dates
1 Oct 2016to 6 Oct 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Bedridden

Who cannot join

  • Neurodegenerative disease (i.e.Parkinson's disease, Alzheimer's disease)
  • Heart failure
  • Organ transplantation
  • Liver failure
  • Kidney failure
  • Hemorrhage
  • Neuromuscular diseases

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Mons. Mazzali Foundation

    Mantua

  • University of Milan

    Milan

  • University of Verona

    Verona, 37129

Other trials in Italy

About this study

Official title: Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old

With aging, vascular function (VF) declines. Inactivity and sedentary life style have been shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used for the management of many chronic conditions, has been proven to lead to even more deleterious consequences, including VF decline.

This study evaluates the effect of passive mobilization of the lower limbs on VF in bedridden oldest-old. Half of the participants will undergo passive mobilization treatment in addition to standard therapies, while the other half will receive only standard therapies. We hypothesize that passive mobilization may improve nitric oxide (NO)-mediated endothelial function.

Read the detailed description

Normally, cardiovascular function declines with age. Furthermore, cardiovascular function declines with immobility, promoting other adverse effects such as postural hypotension, impaired cardiac function, and thrombogenic events. Bed rest, a condition normally used in the management of many chronic pathologies in elderly people, leads to significant functional decline, reduction in physiologic reserve of most of the organ systems, including further cardiovascular decline. Fortunately, several studies have suggested interventions that may counteract immobility-induced cardiovascular dysfunction and ensure beneficial adaptations in the aging population. For example, passive mobilization of the limbs has been shown to improve cardiovascular function in bedridden oldest-old. However, the effect of passive mobilization on NO-mediated endothelial function have not been studied yet. Thus, the main aim of the study is to determine whether passive mobilization is an effective strategy to counteract endothelial dysfunction in bedridden oldest-old. For this purpose, bedridden individuals will be recruited and randomly assigned to two groups: one group will undergo passive mobilization treatment (PM) in addition to standard therapies, the other group (CTRL) will undergo standard therapies only. On the basis of preliminary data on a subgroup of ten participants, a sample of eighteen individuals will be allocated in each group so to reach a statistical power >0.80 and an alpha <0.05. The PM treatment will include knee flexion-extension and it will be performed for 30 minutes, 2 times a day, 5 days a week for 4 weeks.

Before, after the 4-week treatment, and 1 month after the end of the treatment NO-mediated endothelial function of all participants will be evaluated by means of flow-mediated dilation and passive limb movement tests.

Being tested
Passive mobilization - PM
Keywords
Flow-mediated dilation, Passive limb movement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive mobilization - PMOther

Study groups in NCT03087643
Study groupRoleWhat they receive
Passive mobilization - PMExperimentalParticipants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Receives: Other: Passive mobilization - PM
Control group - ctrlNo interventionParticipants will receive ther standard therapies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Delta Peak Blood Flow During sPLM

    Through the use of single Passive Limb Movement (sPLM) test, investigators assessed PLM-induced hyperemia [ delta peak; ml/min] in the common femoral artery of both, right and left legs, during and 60 second after a single passive knee flexion and extension lasting 1 second.

    Measured: PRE and POST 4 weeks of treatment

  2. Change of % FMD

    Through the use of Flow-mediated Dilation (FMD) test , investigators assessed the dilation capacity of right the brachial artery (%FMD) during two minutes following 5-minute ischemic occlusion.

    Measured: PRE and POST 4 weeks of treatment

Secondary outcomes (3)

  1. Change of Total Hemoglobin

    Total hemoglobin [uM] in both, right and left vastus lateralis, was assessed by means of Near-infrared Spectroscopy [NIRS] during the sPLM test.

    Measured: PRE and POST 4 weeks of treatment

  2. Change of Range of Motion

    Assessment of the passive force/joint angle relationship during knee passive mobilization

    Measured: PRE and POST 4 weeks of treatment

  3. Change of Thickness of Vastus Lateralis

    Evaluation of the architectural parameters (fascicle length, pinnation angle, and muscle thickness) of the vastus lateralis muscle by ultrasound

    Measured: PRE and POST 4 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study start1 Oct 2016
  3. Primary completion30 Jun 2017
  4. Study completion6 Oct 2017

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087643
Sponsor's protocol ID
241123
Status last verified
Aug 2019
First submitted
10 Mar 2017
Last updated
6 Aug 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Venturelli M, Amann M, Layec G, McDaniel J, Trinity JD, Fjeldstad AS, Ives SJ, Yonnet G, Richardson RS. Passive leg movement-induced hyperaemia with a spinal cord lesion: evidence of preserved vascular function. Acta Physiol (Oxf). 2014 Feb;210(2):429-39. doi: 10.1111/apha.12173. Epub 2013 Nov 5.

    PubMed 24119139

  • Groot HJ, Trinity JD, Layec G, Rossman MJ, Ives SJ, Richardson RS. Perfusion pressure and movement-induced hyperemia: evidence of limited vascular function and vasodilatory reserve with age. Am J Physiol Heart Circ Physiol. 2013 Feb 15;304(4):H610-9. doi: 10.1152/ajpheart.00656.2012. Epub 2012 Dec 21.

    PubMed 23262136

  • Trinity JD, Groot HJ, Layec G, Rossman MJ, Ives SJ, Morgan DE, Gmelch BS, Bledsoe A, Richardson RS. Passive leg movement and nitric oxide-mediated vascular function: the impact of age. Am J Physiol Heart Circ Physiol. 2015 Mar 15;308(6):H672-9. doi: 10.1152/ajpheart.00806.2014. Epub 2015 Jan 9.

    PubMed 25576629

  • Nelson AD, Rossman MJ, Witman MA, Barrett-O'Keefe Z, Groot HJ, Garten RS, Richardson RS. Nitric oxide-mediated vascular function in sepsis using passive leg movement as a novel assessment: a cross-sectional study. J Appl Physiol (1985). 2016 May 1;120(9):991-9. doi: 10.1152/japplphysiol.00961.2015. Epub 2016 Feb 11.

    PubMed 26869709

  • Venturelli M, Layec G, Trinity J, Hart CR, Broxterman RM, Richardson RS. Single passive leg movement-induced hyperemia: a simple vascular function assessment without a chronotropic response. J Appl Physiol (1985). 2017 Jan 1;122(1):28-37. doi: 10.1152/japplphysiol.00806.2016. Epub 2016 Nov 10.

    PubMed 27834672

  • Robine JM, Michel PJ. Looking forward to a general theory on population aging. Tijdschr Gerontol Geriatr. 2006 Sep;37(4):29-37. No abstract available.

    PubMed 17025012

  • Hadi HA, Carr CS, Al Suwaidi J. Endothelial dysfunction: cardiovascular risk factors, therapy, and outcome. Vasc Health Risk Manag. 2005;1(3):183-98.

    PubMed 17319104

  • Ghiadoni L, Salvetti M, Muiesan ML, Taddei S. Evaluation of endothelial function by flow mediated dilation: methodological issues and clinical importance. High Blood Press Cardiovasc Prev. 2015 Mar;22(1):17-22. doi: 10.1007/s40292-014-0047-2. Epub 2014 Mar 12.

    PubMed 24619864

  • Rousseau P. Immobility in the aged. Arch Fam Med. 1993 Feb;2(2):169-77; discussion 178. doi: 10.1001/archfami.2.2.169.

    PubMed 8275186

Questions about this trial

What is this clinical trial studying?

A study testing Passive mobilization - PM in people with Endothelial Dysfunction and Aging, run by Universita di Verona at 3 sites in Italy.

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 1 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Delta Peak Blood Flow During sPLM (time frame: PRE and POST 4 weeks of treatment). 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?

On the ClinicalTrials.gov record for NCT03087643, which also lists 9 linked publications.

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 6 Aug 2019.

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