Metabolic and Chronobiological Changes in Vestibular Rehabilitation

Study Overview
=================
Brief Summary
-----------------
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

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

Official Title
-----------------
Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior

Conditions
-----------------
Vestibular Disorder, Metabolic Disease, Sleep Disorder

Intervention / Treatment
-----------------
* Procedure: Vestibular Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Vestibular Rehabilitation<br>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<br>* 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<br>|
| Experimental: Delayed Vestibular Rehabilitation<br>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<br>* 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<br>|

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 |