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Completed

NCT Number: NCT04690777

Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly

Loss of vestibular function occurs normally with healthy aging but can produce symptoms that reduce motor skills and cause falls. vestibular physical therapy (VPH) exercises are a specific approach to reducing imbalances. The multicomponent therapeutic physical exercise (ME) is an effective non-pharmacological strategy for the improvement of physical condition.

Objective: to determine the efficacy of ME versus VPH for gait improvement. Material and method: a randomized clinical trial was carried out with two intervention groups , applying it to one VPH group and the other ME.

The participants were residents of Geriatric Centers in the province of Seville, Spain with a score between 4 and 9 points according to the "Short Physical Performance Battery" scale (SPPB).

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Key information

Conditions

Physical Therapy Exercise Therapy Gait Sports Physical Therapy

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

This pilot study is a controlled and randomized clinical trial (simple ER) with two groups in parallel, comparing the combination of a multi-component therapeutic exercise protocol (ME) versus vestibular exercises (VPH) in over 70 years. The trial was approved by the Ethics Committee on Research with code 2410-N-19 and the study was conducted in accordance with the Helsinki Declaration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females over 70 years of age.
  • Subjects with a score between 4 and 9 points on the. "Short Physical Performance Battery"" (SPPB) scale

Exclusion criteria

  • Patients unable to walk unaided or those who do not exceed the previous evaluation in SPPB.
  • Polypharmacological patients (combined use of beta blockers, sulpiride or betahistin) were also excluded.

Treatment and study plan

Experimental: VESTIBULAR EXERCISE

Procedure

OCULAR AND MOVEMENT EXERCISES

MULTICOMPONENT EXERCISE

Procedure

exercises includes strengthening, cardiovascular training, flexibility and balance

Primary outcomes

  1. Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery

    Time frame: Change from Baseline at 6 weeks

    The SPPB fitness rating battery consists of three parts: Balance rating, 4 metre gait assessment rating and the Time up and go test (TUG). From 0 (bad) to 12 (well) there is a score which describes de functionality

  2. Speed test

    Time frame: Change from Baseline at 6 weeks

    Speed test. A participants walking speed over a 4 metre distance. This is a continuous quantitative variable measured in meters per second (m/s).

  3. Test Time up and Go

    Time frame: Change from Baseline at 6 weeks

    The participants try to stand up and wlak 3 metres and return sitting. We must record the time.

    • This is a continuous quantitative variable measured in seconds.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly": Pilot Study of a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
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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