Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

Sponsor
University of Seville (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04894929
Collaborator
(none)
90
2
2.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: multi component exercise
  • Other: vestibular exercise
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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 (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.
Primary Purpose:
Treatment
Official Title:
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement Through Vestibular and Multicomponent Exercises.
Anticipated Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: A. Multi-conponente exercise

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

Other: multi component exercise
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.

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
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

Outcome Measures

Primary Outcome Measures

  1. Barthel test [_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)]

    balance

  2. VIDA test [_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)]

    Questionnaire for Instrumental Activities of Daily Living (AIVD)

  3. short Performance Physical Battery (SPPB) [_measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)]

    Gait capacity: SPPB physical function assessment battery

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
  1. Polypharmacological patients (combined use of beta-blockers, sulpiride or betahistine) will also be considered for exclusion.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Seville

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
MARINA LOPEZ GARCIA, Associated Professor, University of Seville
ClinicalTrials.gov Identifier:
NCT04894929
Other Study ID Numbers:
  • Useville2
First Posted:
May 20, 2021
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 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
Keywords provided by MARINA LOPEZ GARCIA, Associated Professor, University of Seville
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021