Metabolic and Chronobiological Changes in Vestibular Rehabilitation

Sponsor
Uniter Onlus (Other)
Overall Status
Completed
CT.gov ID
NCT05174104
Collaborator
(none)
60
1
2
21
2.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vestibular Rehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Vestibular Rehabilitation on Metabolic Aspects and Chronobiological Behavior
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fat Mass Percentage [one month]

    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.

  2. Muscle Mass Percentage [one month]

    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.

  3. Visceral Fat Level [one month]

    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.

Secondary Outcome Measures

  1. Total daily EE (Kcal/day) [one month]

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  2. Hours/day spent upright [one month]

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  3. Number of strides and distance (Km) [one month]

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used.

  4. Daily movement EE (Kcal/day) [one month]

    The Apple Watch 44 mm (5th generation) using watchOS 6 (Apple Inc., Cupertino, California, USA) will be used to calculate.

  5. EE (Kcal/min) [one month]

    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).

  6. sleep onset latency (minutes) [one month]

    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.

  7. total sleep time (minutes) [one month]

    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.

  8. wake time after sleep onset (minutes) [one month]

    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.

  9. sleep efficiency (percentage) [one month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ITER Center for Balance and Rehabilitation Research Guidonia Rome Italy 00012

Sponsors and Collaborators

  • Uniter Onlus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Uniter Onlus
ClinicalTrials.gov Identifier:
NCT05174104
Other Study ID Numbers:
  • UniterVestib
First Posted:
Dec 30, 2021
Last Update Posted:
Dec 30, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2021