Skip to main content
OpenTrials
Completed

NCT Number: NCT03087643

Passive Mobilization and Vascular Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endothelial Dysfunction Aging Bed Rest

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mons. Mazzali Foundation, Mantua, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive mobilization - PM

Other

Primary outcomes

  1. Change of Delta Peak Blood Flow During sPLM

    Time frame: PRE and POST 4 weeks of treatment

    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.

  2. Change of % FMD

    Time frame: PRE and POST 4 weeks of treatment

    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.

Secondary outcomes

  1. Change of Total Hemoglobin

    Time frame: PRE and POST 4 weeks of treatment

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

  2. Change of Range of Motion

    Time frame: PRE and POST 4 weeks of treatment

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

  3. Change of Thickness of Vastus Lateralis

    Time frame: PRE and POST 4 weeks of treatment

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

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Collaborators

  • Fondazione Mons. Arrigo Mazzali - ONLUS
  • University of Milan

Registry information

Official study title

Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.