Passive Mobilization and Vascular Function

Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03087643

Enrollment

Registered

2017-03-22

Start date

2016-10-01

Completion date

2017-10-06

Last updated

2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Bed Rest, Endothelial Dysfunction

Keywords

Flow-mediated dilation, Passive limb movement

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.

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.

Interventions

OTHERPassive mobilization - PM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 110 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Delta Peak Blood Flow During sPLM	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.
Change of % FMD	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

Measure	Time frame	Description
Change of Total Hemoglobin	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.
Change of Range of Motion	PRE and POST 4 weeks of treatment	Assessment of the passive force/joint angle relationship during knee passive mobilization
Change of Thickness of Vastus Lateralis	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

Countries

Italy

Participant flow

Participants by arm

Arm	Count
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. Passive mobilization - PM	26
Control Group - Ctrl Participants will receive ther standard therapies.	25
Total	51

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	2	2
Overall Study	Withdrawal by Subject	2	4

Baseline characteristics

Characteristic	Passive Mobilization - PM	Total	Control Group - Ctrl
Age, Continuous	85 years STANDARD_DEVIATION 8	86 years STANDARD_DEVIATION 7	87 years STANDARD_DEVIATION 6
Delta Peak Blood Flow during sPLM	113.7 ml/min STANDARD_DEVIATION 69.1	104.5 ml/min STANDARD_DEVIATION 69.8	100.3 ml/min STANDARD_DEVIATION 70.4
%Flow mediated dilation (FMD)	9.6 % STANDARD_DEVIATION 2.6	7.3 % STANDARD_DEVIATION 2.3	6.4 % STANDARD_DEVIATION 2
Muscle-Tendon Unit Stiffness	0.86 N/° STANDARD_DEVIATION 0.06	0.86 N/° STANDARD_DEVIATION 0.06	0.86 N/° STANDARD_DEVIATION 0.06
Muscle thickness Vastus Lateralis	14.78 mm STANDARD_DEVIATION 4.09	14.59 mm STANDARD_DEVIATION 6.72	14.52 mm STANDARD_DEVIATION 3.69
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	26 Participants	51 Participants	25 Participants
Range of Motion	46.45 ° STANDARD_DEVIATION 33.37	44.37 ° STANDARD_DEVIATION 24.56	41.24 ° STANDARD_DEVIATION 6
Region of Enrollment Italy	26 participants	51 participants	25 participants
Sex: Female, Male Female	16 Participants	32 Participants	16 Participants
Sex: Female, Male Male	10 Participants	19 Participants	9 Participants
Total Hemoglobin (mmol/L)	35.2 mmol/L STANDARD_DEVIATION 20.8	29.8 mmol/L STANDARD_DEVIATION 15.5	25.3 mmol/L STANDARD_DEVIATION 12.9

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 26	2 / 25
other Total, other adverse events	0 / 26	0 / 25
serious Total, serious adverse events	0 / 26	0 / 25

Outcome results

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.