Passive Mobilization and Vascular Function

August 5, 2019 updated by: Massimo Venturelli, PhD, Universita di Verona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Mantua, Italy
        • Mons. Mazzali Foundation
      • Milan, Italy
        • University of Milan
      • Verona, Italy, 37129
        • University of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 110 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Passive mobilization - PM
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
NO_INTERVENTION: Control group - ctrl
Participants will receive ther standard therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PRE and POST 4 weeks of treatment
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.
PRE and POST 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PRE and POST 4 weeks of treatment
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
PRE and POST 4 weeks of treatment
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
PRE and POST 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Collaborators

University of Milan
Fondazione Mons. Arrigo Mazzali - ONLUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

October 6, 2017

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (ACTUAL)

March 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 241123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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