NCT03087643

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 6, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

March 10, 2017

Results QC Date

February 9, 2018

Last Update Submit

August 5, 2019

Conditions

Endothelial DysfunctionAgingBed Rest

Keywords

Flow-mediated dilationPassive limb movement

Outcome Measures

Primary Outcomes (2)

  • 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.

    PRE and POST 4 weeks of treatment

  • 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.

    PRE and POST 4 weeks of treatment

Secondary Outcomes (3)

  • Change of Total Hemoglobin

    PRE and POST 4 weeks of treatment

  • Change of Range of Motion

    PRE and POST 4 weeks of treatment

  • Change of Thickness of Vastus Lateralis

    PRE and POST 4 weeks of treatment

Study Arms (2)

Passive mobilization - PM

EXPERIMENTAL

Participants 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.

Other: Passive mobilization - PM

Control group - ctrl

NO INTERVENTION

Participants will receive ther standard therapies.

Interventions

Passive mobilization - PMOTHER
Passive mobilization - PM

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Bedridden

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mons. Mazzali Foundation

Mantova, Italy

Location

University of Milan

Milan, Italy

Location

University of Verona

Verona, 37129, Italy

Location

Related Publications (9)

  • 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.

    PMID: 24119139BACKGROUND

  • 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.

    PMID: 23262136BACKGROUND

  • 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.

    PMID: 25576629BACKGROUND

  • 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.

    PMID: 26869709BACKGROUND

  • 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.

    PMID: 27834672BACKGROUND

  • 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.

    PMID: 17025012BACKGROUND

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

    PMID: 17319104BACKGROUND

  • 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.

    PMID: 24619864BACKGROUND

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

    PMID: 8275186BACKGROUND

Results Point of Contact

Title
Dr. Massimo Venturelli
Organization
University of Verona
massimo.venturelli@univr.it
00390458415114

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 22, 2017

Study Start

October 1, 2016

Primary Completion

June 30, 2017

Study Completion

October 6, 2017

Last Updated

August 6, 2019

Results First Posted

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)