Clinical trial NCT02541305: EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY
Official title: EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: falls prevention
proprioception
physical condition
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz
First posted: 2015-09-04
Enrollment: 50
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.

Detailed description: The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.

Thereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.

The control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.

The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.

To determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.

Eligibility criteria: Inclusion Criteria:

* Being institutionalized,
* own ability to read and write,
* and access the study voluntarily.

Exclusion Criteria:

* Significant degree of cognitive impairment;
* intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
* as well as those who did not complete 90% of the sessions.

Primary outcomes:
measure: Time Up and Go (TUG) test
timeFrame: Participants will be followed an expected average of 5 weeks.
Secondary outcomes:
measure: Tinnetti scale
timeFrame: Participants will be followed an expected average of 5 weeks.
measure: Questionnaire risk of falls in hospital (Morse)
timeFrame: Participants will be followed an expected average of 5 weeks.
measure: Cooper test
timeFrame: Participants will be followed an expected average of 5 weeks.
measure: Support time monopodal
timeFrame: Participants will be followed an expected average of 5 weeks.
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz
state: Extremadura
Study officials:
affiliation: University of Extremadura
name: María Ángeles Cardero-Durán, PhD
role: PRINCIPAL_INVESTIGATOR
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