Metabolic and Chronobiological Changes in Vestibular Rehabilitation

Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior

The aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinical validated scales

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Metabolic Disease; Vestibular Disorder
• Intervention / Treatment: Procedure: Vestibular Rehabilitation

Detailed Description

Recent advances in the field of vestibular-related disorders demonstrated that such conditions may interfere on different pathways underpinning metabolic behaviour, daily life activities and also chronotype behaviour. However, no studies evaluated how vestibular rehabilitation procedures - well established in literature - may interfere on these vestibular-related disorders. On the other side, recent advances in portable bioelectrical impedenzometry devices, smart watches devised to evaluate energy expenditure during daily life activities and actigraphy devices demonstrated to be useful in continuously monitoring different aspects of metabolic, activity and sleep behaviour.

Thus, the aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinically validated scales

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome
    • Guidonia, Rome, Italy, 00012
      • ITER Center for Balance and Rehabilitation Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral vestibular hypofunction achieved according to accepted criteria, by bithermal caloric irrigation, showing at least 25% reduced vestibular response on one side when calculated by means of Jongkees' formula, 3 months or later after symptom onset. In order to avoid confounding factors, and following previous experiences, only subjects presenting with a concurrent reduction in vestibulo-ocular reflex (VOR) gain when studied by means of video head impulse test will be included in this study.

Exclusion Criteria:

• History of falls, cardiovascular, metabolic, rheumatologic, orthopedic, or other neurological conditions, liver or renal abnormalities.
• pregnancy or breastfeeding.
• Neurological and neuro-psychiatric diseases
• insulin-dependent diabetes, vitamin deficiencies, hypothyroidism, lung diseases, hepatitis, chronic kidney failure, and Cushing syndrome
• medication possibly impacting on cochleo-vestibular function or with a history of drug or alcohol addiction
• inability to understand and agree to the examination procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Vestibular Rehabilitation; This group will undergo a 4 weeks of vestibular rehabilitation in the first month and then it will be only followed up in the second month	Procedure: Vestibular Rehabilitation; The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day
Experimental: Delayed Vestibular Rehabilitation; This group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month	Procedure: Vestibular Rehabilitation; The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat Mass Percentage	Fat mass percentage will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.	one month
Muscle Mass Percentage	Muscle mass percentage will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.	one month
Visceral Fat Level	Visceral fat level will be calculated by using single-frequency BIA with eight-point tactile electrodes (Omron HBF-500 BIA, Omron Medizintechnik, Mannheim, Germany), whose reliability with DXA and MRI measurements was previously demonstrated will be used. This device uses an AC of 500 µA with a single frequency of 50 kHz and eight electrodes in a tetrapolar arrangement, requiring the subject to stand on metal footpads in bare feet and grasp a pair of electrodes fxed on a handle, with arms extended in front of the chest.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily EE (Kcal/day)	The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.	one month
Hours/day spent upright	The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.	one month
Number of strides and distance (Km)	The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.	one month
Daily movement EE (Kcal/day)	The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate.	one month
EE (Kcal/min)	The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate this outocome in four targeted conditions (typing, loading the dishwasher, sweeping and walking upstairs and downstairs).	one month
sleep onset latency (minutes)	Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.	one month
total sleep time (minutes)	Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.	one month
wake time after sleep onset (minutes)	Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.	one month
sleep efficiency (percentage)	Actigraphy analysis will be performed for 1 week, using the wGT3X-BT device by ActiGraph (Pensacola, FL, USA). This device is a triaxial accelerometer measuring wrist acceleration in three orthogonal axes at a sampling frequency of 80 Hz. This device is waterproof, with a battery life of approximately 3 weeks. The device does not provide any feedback to the participants about their activity or sleep. The acceleration data collected by the device will be used to obtain the estimates of this outcome for the whole week.	one month

Collaborators and Investigators

• Sponsor: Uniter Onlus

Publications and helpful links

General Publications

• Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.
• Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.
• Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
• Micarelli A, Viziano A, Pistillo R, Granito I, Micarelli B, Alessandrini M. Sleep Performance and Chronotype Behavior in Unilateral Vestibular Hypofunction. Laryngoscope. 2021 Oct;131(10):2341-2347. doi: 10.1002/lary.29719. Epub 2021 Jun 30.
• Micarelli A, Viziano A, Micarelli B, Augimeri I, Alessandrini M. Vestibular rehabilitation in older adults with and without mild cognitive impairment: Effects of virtual reality using a head-mounted display. Arch Gerontol Geriatr. 2019 Jul-Aug;83:246-256. doi: 10.1016/j.archger.2019.05.008. Epub 2019 May 10.
• Alessandrini M, Viziano A, Pistillo R, Granito I, Basso L, Preziosi N, Micarelli A. Changes in daily energy expenditure and movement behavior in unilateral vestibular hypofunction: Relationships with neuro-otological parameters. J Clin Neurosci. 2021 Sep;91:200-208. doi: 10.1016/j.jocn.2021.07.012. Epub 2021 Jul 17.
• Micarelli A, Viziano A, Granito I, Micarelli RX, Felicioni A, Alessandrini M. Changes in body composition in unilateral vestibular hypofunction: relationships between bioelectrical impedance analysis and neuro-otological parameters. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2603-2611. doi: 10.1007/s00405-020-06561-z. Epub 2021 Jan 3.
• McKeown J, McGeoch PD, Grieve DJ. The influence of vestibular stimulation on metabolism and body composition. Diabet Med. 2020 Jan;37(1):20-28. doi: 10.1111/dme.14166. Epub 2019 Nov 8.
• Fuller PM, Jones TA, Jones SM, Fuller CA. Neurovestibular modulation of circadian and homeostatic regulation: vestibulohypothalamic connection? Proc Natl Acad Sci U S A. 2002 Nov 26;99(24):15723-8. doi: 10.1073/pnas.242251499. Epub 2002 Nov 14.
• McGeoch PD. Can Vestibular Stimulation be Used to Treat Obesity?: Vestibular stimulation targeting the otoliths could rebalance energy homeostasis to trigger a leaner body habitus and thus treat metabolic syndrome. Bioessays. 2019 Feb;41(2):e1800197. doi: 10.1002/bies.201800197. Epub 2019 Jan 7.
• Fuller PM, Jones TA, Jones SM, Fuller CA. Evidence for macular gravity receptor modulation of hypothalamic, limbic and autonomic nuclei. Neuroscience. 2004;129(2):461-71. doi: 10.1016/j.neuroscience.2004.05.059.
• Tighilet B, Chabbert C. Adult neurogenesis promotes balance recovery after vestibular loss. Prog Neurobiol. 2019 Mar;174:28-35. doi: 10.1016/j.pneurobio.2019.01.001. Epub 2019 Jan 15.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Disease; Sleep Wake Disorders; Vestibular Diseases; Metabolic Diseases
• Other Study ID Numbers: UniterVestib

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