Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

June 11, 2023 updated by: MARINA LOPEZ GARCIA, University of Seville

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Sevilla, Spain, 41012
        • Fundomar Elderly nursing home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A. Multi-conponente exercise
  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
Other: multi component exercise in the clinic

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.

Other: multi component exercise at home telerehabilitation

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.
Experimental: B. Vestibular exercise

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.
Other: vestibular exercise in the clinic

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

Other: vestibular exercise at home telerehabilitation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel test
Time Frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
balance
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
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)
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)
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
_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Study Director: Carmen Suárez Serrano, PT, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 16, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Useville2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The intention is to publish in an impact magazine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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