Passive Mobilization and Vascular Function

Aging Clinical Trial

Official title:

Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087643
• Other study ID #: 241123
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: October 6, 2017

Study information

• Verified date: August 2019
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 6, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

Inclusion Criteria:

• Bedridden

Exclusion Criteria:

• Neurodegenerative disease (i.e.Parkinson's disease, Alzheimer's disease)

• Heart failure

• Organ transplantation

• Liver failure

• Kidney failure

• Hemorrhage

• Neuromuscular diseases

Related Conditions & MeSH terms

• Aging
• Bed Rest
• Endothelial Dysfunction

Intervention

Other:
• Passive mobilization - PM

Locations

Country	Name	City	State
Italy	Mons. Mazzali Foundation	Mantua
Italy	University of Milan	Milan
Italy	University of Verona	Verona

Sponsors (3)

Lead Sponsor	Collaborator
Universita di Verona	Fondazione Mons. Arrigo Mazzali - ONLUS, University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

Robine JM, Michel PJ. Looking forward to a general theory on population aging. Tijdschr Gerontol Geriatr. 2006 Sep;37(4):29-37. — View Citation

Rousseau P. Immobility in the aged. Arch Fam Med. 1993 Feb;2(2):169-77; discussion 178. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	PRE and POST 4 weeks of treatment
Secondary	Change of Range of Motion	Assessment of the passive force/joint angle relationship during knee passive mobilization	PRE and POST 4 weeks of treatment
Secondary	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	PRE and POST 4 weeks of treatment