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NCT Number: NCT04894929

Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

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

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Key information

Conditions

Aging Behavior Ear Diseases Labyrinth Diseases Motor Activity Otorhinolaryngologic Diseases Physical Activity Physiotherapy Vestibular Diseases Vestibular Disorder

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundomar Elderly nursing home

Seville, 41012, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Polypharmacological patients (combined use of beta-blockers, sulpiride or betahistine) will also be considered for exclusion.

Treatment and study plan

multi component exercise in the clinic

Other

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 clinic

Other

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 telerehabilitation

Other

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 telerehabilitation

Other

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 outcomes

  1. Barthel test

    Time frame: _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

    balance

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement Through Vestibular and Multicomponent Exercises.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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