AgingNCT04894929
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
A study testing multi component exercise in the clinic, vestibular exercise in the clinic and vestibular exercise at home telerehabilitation in people with Aging and Vestibular Disorder, run by University of Seville at 1 site in Spain.
Trial summary
14.44% of the Spanish population is over 70 years old and Aging as a normal process is characterized by gradual modifications in the physiological functions of the different systems, so that as age progresses, deterioration can lead to imbalances and alterations in health that cause diseases or traumatic processes. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aging, Vestibular Disorder, Physiotherapy
- What is being tested?
- multi component exercise in the clinic, vestibular exercise in the clinic and vestibular exercise at home telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Women and men over 70 years old.
- Having assessed through the VALINTAN (online free tool in primary care por comprehensive assessment of the elderly) of function their integral functional status and determining as a health process deterioration functional and lack of physical activity.
- Subjects with a score between 4 and 9 points according to the "Short Physical Performance Battery" (SPPB) scale
Who cannot join
- 1) patients without gait independence or who did not pass the previous evaluation in SPPB.
- 2) Polypharmacological patients (combined use of beta-blockers, sulpiride or betahistine) will also be considered for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement Through Vestibular and Multicomponent Exercises.
14.44% of the Spanish population is over 70 years old and Aging as a normal process is characterized by gradual modifications in the physiological functions of the different systems, so that as age progresses, deterioration can lead to imbalances and alterations in health that cause diseases or traumatic processes. Within these processes, vestibular loss occurs normally in the face of healthy aging and, encompassed within this progressive dysfunction, various symptoms such as dizziness, imbalances, facial and limb weakness, confusion or headache may occur.
Functional status is the best indicator of the overall health status of the elderly person. Identifying these indicators as soon as possible is the best way to prevent functional decline and promote active aging and life expectancy free of disability. For this reason, there are strategies that are currently a priority in health systems. The special COVID circumstances eliminate the possibility of group work and invite the realization at home or individually of workshops or collective exercises In the field of physiotherapy, vestibular exercises have shown efficacy for improving balance and reducing the risk of falls in cognitively intact people without vestibular impairment, being a specific approach to vestibular rehabilitation for the reduction of dizziness and imbalances , as it facilitates the compensation of the Central Nervous System. physiotherapy intervention has been shown in various studies to be effective in improving balance and reducing the risk of falls in older people.
Read more
Also considering that the control of body balance in the elderly depends not only on the vestibular system, but also on the correlations between all the other systems, it seems interesting to add exercises with multiple components, since it would add effects of improvement in functional independence of people greater for daily activities and control of body balance.
Therapeutic physical exercise is an effective non-pharmacological strategy to improve the functional condition of the elderly and although it is known that there are various exercise modalities that improve physical function and quality of life, The Clinical Practice Guidelines emphasize the importance of multicomponent / multimodal exercise for this population group
Read the detailed description
Therefore, and given the information in both directions, we consider that it is necessary to determine the efficacy in the evidence of both actions (multicomponent exercise and vestibular exercises) to improve functional capacity and thus prevent falls, conducting a randomized clinical trial that compares the effectiveness of both interventions. Given the special circumstances during the COVID-19 pandemic, an online or virtual follow-up is necessary to achieve the exercises, building a resource website and helping virtual access and monitoring to carry out the personalized exercise.
Thus, this set of interventions can be carried out by making an initial diagnosis of pre-frailty or frailty using instruments and simple validated tests. This is indicated or recommended in the guidelines from national and international societies. In this sense, we can avail ourselves of a comprehensive assessment of the VALINTAN tool (computerized comprehensive assessment of the elderly and used in primary care), whose axis is function, focuses on predefined diagnoses associated with effective documented interventions or with the fragility or functional loss. Currently the tool is open and freely accessible
- Conditions
- Aging, Vestibular Disorder, Physiotherapy, Physical Activity
- Being tested
- multi component exercise in the clinic, vestibular exercise in the clinic, vestibular exercise at home telerehabilitation, multi component exercise at home telerehabilitation
- Keywords
- aging, physiotherapy, physical activity, balance
- Medical subject headings
- Vestibular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi component exercise in the clinicOther
Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform:
3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work.
vestibular exercise in the clinicOther
Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of:
to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress.
and. Along with push up 30sec and squat 30sec
vestibular exercise at home telerehabilitationOther
Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of:
to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress.
and. Along with push up 30sec and squat 30sec
multi component exercise at home telerehabilitationOther
Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video:
3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work.
| Study group | Role | What they receive |
|---|---|---|
| A. Multi-conponente exercise | Experimental | 1. A 6-week therapeutic multi-component physical exercise program will be carried out. The ministerial guide will be followed by carrying out 5 weekly sessions (from Monday to Friday), offering the application through a web link of the weekly programming of the exercises for the patient (type of exercise, video of its execution, number of repetitions and description) having a approximate duration of 40 minutes.
2. Said sessions will be carried out daily and from the center a call was made at the end of the week to mark the follow-up and resolve any questions related to symptoms Receives: Other: multi component exercise in the clinic; Other: multi component exercise at home telerehabilitation |
| B. Vestibular exercise | Experimental | The vestibular exercises will be performed with the instructions of a physiotherapist, in sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of:
to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress.
and. Along with push up 30sec and squat 30sec All participants will have a weekly follow-up from Monday to Friday to control attendance and compliance via telephone. Receives: Other: vestibular exercise in the clinic; Other: vestibular exercise at home telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel test
balance
Measured: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
VIDA test
Questionnaire for Instrumental Activities of Daily Living (AIVD)
Measured: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
short Performance Physical Battery (SPPB)
Gait capacity: SPPB physical function assessment battery
Measured: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Sep 2021
- Primary completion30 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- set of interventions can be carried out by making an initial diagnosis of pre-frailty or frailty using instruments and simple validated tests. This is indicated or thus recommended in the guidelines from national and international societies (24-25). In this sense, we can use a comprehensive assessment of the VALINTAN (computerized) tool, a VGI-type assessment, whose axis is function, focusing on predefined diagnoses associated with effective documented interventions or with functional fragility or loss. Currently the tool is open and freely accessible (26).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARINA LOPEZ GARCIA, University of Seville
- Investigators
- Carmen Suárez Serrano, PT, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894929
- Sponsor's protocol ID
- Useville2
- Status last verified
- Jun 2023
- First submitted
- 9 May 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The intention is to publish in an impact magazine
Publications
Kularbpthettong K. Effects of the Physical Therapy Application for Elderly. Advances in Intelligent Systems and Computing. 2020 Vol 1152: 462-467
Iwasaki S, Yamasoba T. Dizziness and Imbalance in the Elderly: Age-related Decline in the Vestibular System. Aging Dis. 2014 Feb 9;6(1):38-47. doi: 10.14336/AD.2014.0128. eCollection 2015 Feb.
PubMed 25657851Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
PubMed 19468085Agrawal Y, Zuniga MG, Davalos-Bichara M, Schubert MC, Walston JD, Hughes J, Carey JP. Decline in semicircular canal and otolith function with age. Otol Neurotol. 2012 Jul;33(5):832-9. doi: 10.1097/MAO.0b013e3182545061.
PubMed 22699991Brown KE, Whitney SL, Marchetti GF, Wrisley DM, Furman JM. Physical therapy for central vestibular dysfunction. Arch Phys Med Rehabil. 2006 Jan;87(1):76-81. doi: 10.1016/j.apmr.2005.08.003.
PubMed 16401442Klatt BN, Ries JD, Dunlap PM, Whitney SL, Agrawal Y. Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. J Neurol Phys Ther. 2019 Apr;43 Suppl 2(Suppl 2 Spec INTERNATIONAL CONFERENCE ON VESTIBULAR REHABILITATION):S14-S19. doi: 10.1097/NPT.0000000000000266.
PubMed 30883488Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
PubMed 26913496Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
PubMed 22071817Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
PubMed 30108511Martins E Silva DC, Bastos VH, de Oliveira Sanchez M, Nunes MK, Orsini M, Ribeiro P, Velasques B, Teixeira SS. Effects of vestibular rehabilitation in the elderly: a systematic review. Aging Clin Exp Res. 2016 Aug;28(4):599-606. doi: 10.1007/s40520-015-0479-0. Epub 2015 Oct 28.
PubMed 26511625Macias JD, Massingale S, Gerkin RD. Efficacy of vestibular rehabilitation therapy in reducing falls. Otolaryngol Head Neck Surg. 2005 Sep;133(3):323-5. doi: 10.1016/j.otohns.2005.04.024.
PubMed 16143174Beato M, Dawson N, Svien L, Wharton T. Examining the Effects of an Otago-Based Home Exercise Program on Falls and Fall Risks in an Assisted Living Facility. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):224-229. doi: 10.1519/JPT.0000000000000190.
PubMed 29698252Fishleder S, Petrescu-Prahova M, Harris JR, Leroux B, Bennett K, Helfrich CD, Kohn M, Hannon P. Predictors of Improvement in Physical Function in Older Adults in an Evidence-Based Physical Activity Program (EnhanceFitness). J Geriatr Phys Ther. 2019 Oct/Dec;42(4):230-242. doi: 10.1519/JPT.0000000000000202.
PubMed 29979352Bean JF, Brown L, DeAngelis TR, Ellis T, Kumar VSS, Latham NK, Lawler D, Ni M, Perloff J. The Rehabilitation Enhancing Aging Through Connected Health Prehabilitation Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):1999-2005. doi: 10.1016/j.apmr.2019.04.015. Epub 2019 May 29.
PubMed 31152705Canli S, Ozyurda F. A multi-modal exercise intervention that improves cognitive function and physical performance, elderly with mobility-related disability: a randomized controlled trial. J Sports Med Phys Fitness. 2020 Jul;60(7):1027-1033. doi: 10.23736/S0022-4707.20.10286-X. Epub 2020 Apr 6.
PubMed 32253894
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement Through Vestibular and Multicomponent Exercises.
- ClinicalTrials.gov ID
- NCT04894929
- Acronym / sponsor ID
- Useville2
- Conditions
- Aging, Vestibular Disorder, Physiotherapy, Physical Activity
- Keywords
- aging, physiotherapy, physical activity, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
14.44% of the Spanish population is over 70 years old and Aging as a normal process is characterized by gradual modifications in the physiological functions of the different systems, so that as age progresses, deterioration can lead to imbalances and alterations in health that cause diseases or traumatic processes. Within these processes, vestibular loss occurs normally in the face of healthy aging and, encompassed within this progressive dysfunction, various symptoms such as dizziness, imbalances, facial and limb weakness, confusion or headache may occur.
Functional status is the best indicator of the overall health status of the elderly person. Identifying these indicators as soon as possible is the best way to prevent functional decline and promote active aging and life expectancy free of disability. For this reason, there are strategies that are currently a priority in health systems. The special COVID circumstances eliminate the possibility of group work and invite the realization at home or individually of workshops or collective exercises In the field of physiotherapy, vestibular exercises have shown efficacy for improving balance and reducing the risk of falls in cognitively intact people without vestibular impairment, being a specific approach to vestibular rehabilitation for the reduction of dizziness and imbalances , as it facilitates the compensation of the Central Nervous System. physiotherapy intervention has been shown in various studies to be effective in improving balance and reducing the risk of falls in older people.
Also considering that the control of body balance in the elderly depends not only on the vestibular system, but also on the correlations between all the other systems, it seems interesting to add exercises with multiple components, since it would add effects of improvement in functional independence of people greater for daily activities and control of body balance.
Therapeutic physical exercise is an effective non-pharmacological strategy to improve the functional condition of the elderly and although it is known that there are various exercise modalities that improve physical function and quality of life, The Clinical Practice Guidelines emphasize the importance of multicomponent / multimodal exercise for this population group
Detailed description
Therefore, and given the information in both directions, we consider that it is necessary to determine the efficacy in the evidence of both actions (multicomponent exercise and vestibular exercises) to improve functional capacity and thus prevent falls, conducting a randomized clinical trial that compares the effectiveness of both interventions. Given the special circumstances during the COVID-19 pandemic, an online or virtual follow-up is necessary to achieve the exercises, building a resource website and helping virtual access and monitoring to carry out the personalized exercise.
Thus, this set of interventions can be carried out by making an initial diagnosis of pre-frailty or frailty using instruments and simple validated tests. This is indicated or recommended in the guidelines from national and international societies. In this sense, we can avail ourselves of a comprehensive assessment of the VALINTAN tool (computerized comprehensive assessment of the elderly and used in primary care), whose axis is function, focuses on predefined diagnoses associated with effective documented interventions or with the fragility or functional loss. Currently the tool is open and freely accessible
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- set of interventions can be carried out by making an initial diagnosis of pre-frailty or frailty using instruments and simple validated tests. This is indicated or thus recommended in the guidelines from national and international societies (24-25). In this sense, we can use a comprehensive assessment of the VALINTAN (computerized) tool, a VGI-type assessment, whose axis is function, focusing on predefined diagnoses associated with effective documented interventions or with functional fragility or loss. Currently the tool is open and freely accessible (26).
| Arm | Type | Receives |
|---|---|---|
| A. Multi-conponente exercise | Experimental | Other: multi component exercise in the clinic, Other: multi component exercise at home telerehabilitation1. A 6-week therapeutic multi-component physical exercise program will be carried out. The ministerial guide will be followed by carrying out 5 weekly sessions (from Monday to Friday), offering the application through a web link of the weekly programming of the exercises for the patient (type of exercise, video of its execution, number of repetitions and description) having a approximate duration of 40 minutes. 2. Said sessions will be carried out daily and from the center a call was made at the end of the week to mark the follow-up and resolve any questions related to symptoms |
| B. Vestibular exercise | Experimental | Other: vestibular exercise in the clinic, Other: vestibular exercise at home telerehabilitationThe vestibular exercises will be performed with the instructions of a physiotherapist, in sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec All participants will have a weekly follow-up from Monday to Friday to control attendance and compliance via telephone. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Women and men over 70 years old.
- Having assessed through the VALINTAN (online free tool in primary care por comprehensive assessment of the elderly) of function their integral functional status and determining as a health process deterioration functional and lack of physical activity.
- Subjects with a score between 4 and 9 points according to the "Short Physical Performance Battery" (SPPB) scale
Key exclusion criteria (2 listed)
- 1) patients without gait independence or who did not pass the previous evaluation in SPPB.
- 2) Polypharmacological patients (combined use of beta-blockers, sulpiride or betahistine) will also be considered for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi component exercise in the clinicPatients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform: 3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work. | Other | A. Multi-conponente exercise |
| vestibular exercise in the clinicPatients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec | Other | B. Vestibular exercise |
| vestibular exercise at home telerehabilitationPatients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec | Other | B. Vestibular exercise |
| multi component exercise at home telerehabilitationPatients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video: 3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work. | Other | A. Multi-conponente exercise |
Primary outcome
Barthel test
Time frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
balance
VIDA test
Time frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
Questionnaire for Instrumental Activities of Daily Living (AIVD)
short Performance Physical Battery (SPPB)
Time frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
Gait capacity: SPPB physical function assessment battery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- BackgroundKularbpthettong K. Effects of the Physical Therapy Application for Elderly. Advances in Intelligent Systems and Computing. 2020 Vol 1152: 462-467
- Results publication: PubMed 25657851Iwasaki S, Yamasoba T. Dizziness and Imbalance in the Elderly: Age-related Decline in the Vestibular System. Aging Dis. 2014 Feb 9;6(1):38-47. doi: 10.14336/AD.2014.0128. eCollection 2015 Feb.
- Results publication: PubMed 19468085Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
- Results publication: PubMed 22699991Agrawal Y, Zuniga MG, Davalos-Bichara M, Schubert MC, Walston JD, Hughes J, Carey JP. Decline in semicircular canal and otolith function with age. Otol Neurotol. 2012 Jul;33(5):832-9. doi: 10.1097/MAO.0b013e3182545061.
- Results publication: PubMed 16401442Brown KE, Whitney SL, Marchetti GF, Wrisley DM, Furman JM. Physical therapy for central vestibular dysfunction. Arch Phys Med Rehabil. 2006 Jan;87(1):76-81. doi: 10.1016/j.apmr.2005.08.003.
- Results publication: PubMed 30883488Klatt BN, Ries JD, Dunlap PM, Whitney SL, Agrawal Y. Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. J Neurol Phys Ther. 2019 Apr;43 Suppl 2(Suppl 2 Spec INTERNATIONAL CONFERENCE ON VESTIBULAR REHABILITATION):S14-S19. doi: 10.1097/NPT.0000000000000266.
- Results publication: PubMed 26913496Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
- Results publication: PubMed 22071817Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
- Results publication: PubMed 30108511Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.
- Results publication: PubMed 26511625Martins E Silva DC, Bastos VH, de Oliveira Sanchez M, Nunes MK, Orsini M, Ribeiro P, Velasques B, Teixeira SS. Effects of vestibular rehabilitation in the elderly: a systematic review. Aging Clin Exp Res. 2016 Aug;28(4):599-606. doi: 10.1007/s40520-015-0479-0. Epub 2015 Oct 28.
- Results publication: PubMed 16143174Macias JD, Massingale S, Gerkin RD. Efficacy of vestibular rehabilitation therapy in reducing falls. Otolaryngol Head Neck Surg. 2005 Sep;133(3):323-5. doi: 10.1016/j.otohns.2005.04.024.
- Results publication: PubMed 29698252Beato M, Dawson N, Svien L, Wharton T. Examining the Effects of an Otago-Based Home Exercise Program on Falls and Fall Risks in an Assisted Living Facility. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):224-229. doi: 10.1519/JPT.0000000000000190.
- Health Programme of the European Union. Advantage. Managing failtry.Link provided by the sponsor.
- SPAIN. National Institute of Statistics \[Internet database\].Link provided by the sponsor.
- Individual participant dataSharing planned: No. The intention is to publish in an impact magazine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Suárez Serrano, PT study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi component exercise in the clinic, vestibular exercise in the clinic and vestibular exercise at home telerehabilitation in people with Aging and Vestibular Disorder, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel test (time frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894929, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.