Effectiveness of a Postural Control Exercise Program on Balance and Risk of Falls in Sedentary Older Adults.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Salamanca
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Weekly physical activity
Study Overview
Brief Summary
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.
Detailed Description
INTERVENTION PROTOCOL The target population of our study were older people belonging to one of the older people's associations in the town of Salamanca. The program was offered in the different associations and an inscription sheet was passed in which they had to provide different information related to their personal situation. All the people he wanted signed up.
Once all the participants enrolled in the program, a draw of places was done to guarantee the randomization of the sample, assigning the participants to the intervention group or the control group.
To ensure a sample size with a confidence level of 95% and an error rate of 10%, a larger sample of 96 people was assumed. A total of 112 participants were included in the program.
An initial assessment was made of all program participants, regardless of the group to which they were assigned. In this session, they were given an informed consent that they had to sign it in order to participate in the program.
The most important data when selecting the elderly is the level of physical activity they carry out in their day to day. In this way, the elderly were divided into two groups: a trained group, that is, who was doing physical activity at the current time and had done it during the previous year, regardless of the type it was, according to the criteria established by WHO; and a sedentary group, which included those elderly who did not meet the minimum criteria for recommended physical activity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Weekly physical activity
Time Frame: 1 year
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.
Tinetti Scale
Time Frame: 24 weeks
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.
Number of Falls
Time Frame: 24 weeks
The number of falls suffered by the participant during the last 6 months is recorded.
Test Timed Up & Go (TUG)
Time Frame: 24 weeks
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.
One-Leg Stance Test (OLS)
Time Frame: 24 weeks
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.
Fullerton Advanced Balance Scale (FAB)
Time Frame: 24 weeks
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.
30 Second Chair Stand Test (30SCST)
Time Frame: 24 weeks
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.
Secondary Outcomes
- Adherence(24 weeks)
- Weight(24 weeks)
- Sex(24 weeks)
- Height(24 weeks)
- Body Mass Index (BMI)(24 weeks)
- Date of birth(24 weeks)
Investigators
Pérez-Robledo, Fátima
Professor (Associate)
University of Salamanca