Clinical trial NCT04690777: Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly
Official title: Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly": Pilot Study of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Sports Physical Therapy
Exercise Therapy
Gait
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (MS) versus vestibular exercises (EVs) in over 70 years. participants were randomly assigned to the therapeutic exercise group or the vestibular exercise group
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery
timeFrame: Change from Baseline at 6 weeks
measure: Speed test
timeFrame: Change from Baseline at 6 weeks
measure: Test Time up and Go
timeFrame: Change from Baseline at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Fundomar Elderly nursing home
Study officials:
affiliation: University of Seville
name: MARINA LOPEZ LOPEZ-GARCIA, PT
role: PRINCIPAL_INVESTIGATOR
References:
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