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Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

Primary Purpose

Aging, Vestibular Disorder, Physiotherapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
multi component exercise in the clinic
vestibular exercise in the clinic
vestibular exercise at home telerehabilitation
multi component exercise at home telerehabilitation
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring aging, physiotherapy, physical activity, balance

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women and men over 70 years old.
  2. 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.
  3. Subjects with a score between 4 and 9 points according to the "Short Physical Performance Battery" (SPPB) scale

Exclusion Criteria:

- 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.

Sites / Locations

  • Fundomar Elderly nursing home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A. Multi-conponente exercise

B. Vestibular exercise

Arm Description

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. 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

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.

Outcomes

Primary Outcome Measures

Barthel test
balance
VIDA test
Questionnaire for Instrumental Activities of Daily Living (AIVD)
short Performance Physical Battery (SPPB)
Gait capacity: SPPB physical function assessment battery

Secondary Outcome Measures

Full Information

First Posted
May 9, 2021
Last Updated
June 11, 2023
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04894929
Brief Title
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
Official Title
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement Through Vestibular and Multicomponent Exercises.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Vestibular Disorder, Physiotherapy, Physical Activity
Keywords
aging, physiotherapy, physical activity, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
It has been explained to the patient that the exercises that they are going to perform are going to serve for their functional improvement, but the exercises are different depending on the group to which they have been assigned randomly.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A. Multi-conponente exercise
Arm Type
Experimental
Arm Description
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. 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
Arm Title
B. Vestibular exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
multi component exercise in the clinic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
vestibular exercise in the clinic
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
vestibular exercise at home telerehabilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
multi component exercise at home telerehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Barthel test
Description
balance
Time Frame
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
Title
VIDA test
Description
Questionnaire for Instrumental Activities of Daily Living (AIVD)
Time Frame
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
Title
short Performance Physical Battery (SPPB)
Description
Gait capacity: SPPB physical function assessment battery
Time Frame
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: - 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Suárez Serrano, PT
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Fundomar Elderly nursing home
City
Sevilla
ZIP/Postal Code
41012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The intention is to publish in an impact magazine
Citations:
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Links:
URL
https://www.advantageja.eu/index.php/es/
Description
Health Programme of the European Union. Advantage. Managing failtry.
URL
https://www.sanidad.gob.es/areas/promocionPrevencion/envejecimientoSaludable/fragilidadCaidas/estrategiaSNS/home.htm
Description
Consensus document on prevention of frailty and falls in the elderly. SPAIN. Health Promotion and Prevention Strategy in the SNS Document approved by the Inter-territorial Council of the National Health System on June 11, 2014. Ministry of Health, Social
URL
https://www.ine.es/
Description
SPAIN. National Institute of Statistics [Internet database].

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Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

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