Postural Balance Program in Sedentary Older Adults.

NCT04385784 | Completed

• 1 other identifier: 10.14201/gredos.140334
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Balance

Keywords

Postural balance; Aged; Sedentary Behavior; Exercise Therapy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• Number of Falls

  The number of falls suffered by the participant during the last 6 months is recorded.

  24 weeks

Secondary Outcomes (6)

• Sex

  24 weeks

• Date of birth

  24 weeks

• Weight

  24 weeks

• Height

  24 weeks

• Body Mass Index (BMI)

  24 weeks

Study Arms (3)

Sedentary Intervention Group (SIG)

EXPERIMENTAL

Group of sedentary older adults who perform the intervention and a home-based exercise program.

Other: Balance exercise program.; Other: Home-based exercise program.

Active Intervention Group (AIG)

EXPERIMENTAL

Group of active older adults who perform the intervention and a home-based exercise program.

Other: Balance exercise program.; Other: Home-based exercise program.

Control Group (CG)

ACTIVE COMPARATOR

Group of sedentary older adults who perform a home-based exercise program.

Other: Home-based exercise program.

Interventions

Balance exercise program. OTHER

Multimodal exercise program that combines strength, mobility, elasticity and postural control exercises. It develops once a week for a total of 24 weeks. Each session lasts one hour and is carried out in small groups of 8 to 10 people maximum.

Active Intervention Group (AIG); Sedentary Intervention Group (SIG)

Home-based exercise program. OTHER

Exercises based on the OTAGO program that are carried out at home without supervision. Participants are explained to carry out the program three or four times a week in a safely way.

Active Intervention Group (AIG); Control Group (CG); Sedentary Intervention Group (SIG)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People over 60 year who decide to participate voluntarily.
• Attendance at the Initial Assessment.
• Acceptance of Informed Consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate)

Model Details: The study is interventional, consisting of three arms with parallel monitoring. The first two arms perform an intervention based on physical exercise guided by physiotherapists, in order to improve their balance and postural control. These two arms are differentiated by the level of daily physical activity that their participants have (sedentary and active people). In addition to the guided exercise sessions, they are offered an exercise book to perform at home. The third arm of the study only performs the home-based program and is made up of sedentary people.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 13, 2020
• Study Start: November 3, 2016
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)