Postural Balance Clinical Trial
— PEMaSOfficial title:
Effectiveness of a Postural Control Exercise Program on Balance and Risk of Falls in Sedentary Older Adults.
Verified date | May 2020 |
Source | University of Salamanca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Balance is one of the physical capacities that are altered due to the changes
produced by aging. This represents an increased risk of falls in older adults. In Spain, the
percentage of older people who fall each year is high and carries a series of important
economic and social consequences. Sedentary lifestyle complicates this process, further
increasing the risk of falls in older adults.
Objective: To design and apply a postural control exercise program to improve balance and
reduce the risk of falls in healthy sedentary older adults.
Material and methods: Longitudinal, prospective, quasi-experimental study, in which a balance
program of one weekly session for 24 weeks was developed. 112 healthy people over 60 years of
age participated and were randomly divided into three work groups: Active Intervention Group
(GIA), Sedentary Intervention Group (GIS) and Control Group (CG). His steady state and risk
of falls were analyzed with the following functional tests: Tinetti Scale, Timed Up & Go
Timed Test (TUG), One-Legged Stance Test (OLS), Fullerton Advanced Balance Scale (FAB) and 30
Second Chair Stand Test (30SCST). The GIA and GIS carried out the balance program and
received a workbook to carry out at home. The CG only performed the home exercises.
Status | Completed |
Enrollment | 112 |
Est. completion date | September 13, 2017 |
Est. primary completion date | September 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - People over 60 year who decide to participate voluntarily. - Attendance at the Initial Assessment. - Acceptance of Informed Consent. Exclusion Criteria: - Presence of absolute or relative contraindications to physical exercise. - Presence of serious balance limitations, such as severe neurological, visual or musculoskeletal disorders. - Presence of difficulties to carry out the tests of the Initial Assessment. - Incidents or pathologies suffered during the intervention that interfere with the study. - Failure to attend the Final Assessment. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
University of Salamanca |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weekly physical activity | The number of hours and the intensity level of the physical activity carried out by the participants habitually are recorded. Thus, according to the criteria established by WHO, physically active people are differentiated from sedentary people. It is a variable that determines the group in which the participants are included. | 1 year | |
Primary | Fullerton Advanced Balance Scale (FAB) | It is a validated balance measurement scale in older adults. It consists of 14 items that assess different aspects of the static and dynamic balance. Each item scores from 0 to 4 points, and a total score of 56 points can be achieved. A score below 25 points indicates a high risk of falls. | 24 weeks | |
Primary | Tinetti Scale | It is a validated scale to assess the risk of falls in older adults. It consists of two sections, the first is gait with 12 possible points, and the other is balance with 16 possible points. The maximum score that can be achieved is 28 points. A score below 19 points indicates high risk of falls. | 24 weeks | |
Primary | Test Timed Up & Go (TUG) | It is a validated test to determine the functionality and risk of falls in older adults. To assess it, the time it takes for a person to get up from a chair, walk 6 meters and sit is timed. A score below 10 seconds indicates a high risk of falling. | 24 weeks | |
Primary | One-Leg Stance Test (OLS) | This test evaluates the static balance and the risk of falls of older adults. It consists of maintaining the position on one leg as long as possible. A maximum time of 30 seconds is established. It is done with both legs. A person who holds the position for less than 10 seconds is at risk of falling. | 24 weeks | |
Primary | 30 Second Chair Stand Test (30SCST) | This test is validated to measure strength in the lower extremities as well as the risk of falls in older adults. It consists of counting the number of times a person can stand up and sit down in 30 seconds. There are normal values for each age and sex with which the participant is assess. | 24 weeks | |
Primary | Number of Falls | The number of falls suffered by the participant during the last 6 months is recorded. | 24 weeks | |
Secondary | Sex | The sex of the participants is recorded at the start of the study. | 24 weeks | |
Secondary | Date of birth | The participant's date of birth is collected in order to calculate his age in years. | 24 weeks | |
Secondary | Weight | The weight of the participants is analyzed in kilograms. | 24 weeks | |
Secondary | Height | The height of the subject is determined in meters. | 24 weeks | |
Secondary | Body Mass Index (BMI) | The participant's BMI is calculated from his height and weight. | 24 weeks | |
Secondary | Adherence | Adherence to the program is calculated from the record of the percentage of attendance at the intervention sessions. | 24 weeks |
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