Effects of Training on Fall Risk and Balance Performances

June 15, 2017 updated by: leyla atas balci, Istanbul Medipol University Hospital

Effects of Dual-Task Training and Exercise-Cognitive Activity Combined Training on Fall Risk and Balance Performance in Elderly at Risk of Falls: A Randomised Controlled Trial Study

Dual task training has been shown to reduce the risk of falls more than single task training. However, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The term "dual task" refers to the ability of performing 2 tasks simultaneously, for example, a cognitive and a motor task. Previous studies demonstrated that dual task training is more effective than single task training in reducing falls among elderly. These studies demonstrated that the improvements in balance and gait speed resulted in a decrease of fall frequency. Although dual task training has been shown to reduce the risk of falls more than single task training, to date, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34214
        • Medipol Mega University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 83 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65 years or older
  • literate
  • having a fall incident during the past year
  • ability to walk 10 meter without any support
  • getting more than 13.5 seconds at Timed up and Go test
  • getting less than 24 points at Standardized Mini-Mental State Examination

Exclusion Criteria:

  • neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,
  • orthopaedic involvement or significant visual and auditory impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Single Task Training
Performed balance and gait exercises
Behavioral: Single task training
The participants in single task training received 30 minutes single task balance and gait exercises, 3 times a week for 4 weeks. The program included static and dynamic balance exercises. Static balance exercises involved body stability (e.g., standing legs open and closed, standing with eyes closed, tandem standing, standing on foam surface and one leg standing, standing while throwing and catching a ball ), forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction (backward, side to side), transfer activities (from 1 chair to another) and sit to stand 5 times
EXPERIMENTAL: Dual task training
Performed cognitive activity simultaneously with balance and gait exercises
Behavioral: dual task training
The participants practiced 30 minutes balance and gait exercises while simultaneously performing cognitive tasks. The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The participants practiced cognitive tasks while simultaneously performing balance and gait exercises. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems
EXPERIMENTAL: Exercise-Cognitive Activity Combined Training
Performed cognitive, balance and gait activity training asynchronously at different times during the same day
Behavioral: exercise-cognitive activity combined training
The participants first practiced 30 min of cognitive activities then performed 30 min of balance and gait exercises after 5 min of resting.The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait speed under single task condition
Time Frame: 4 weeks
The participants walked 10 meter at their comfortable speed and the time to complete the task was recorded
4 weeks
Gait speed under dual task condition
Time Frame: 4 weeks
The participants walked 10 meter while producing words which started with letter "K"
4 weeks
Timed Up and Go test
Time Frame: 4 weeks
Timed Up and Go Test is a simple test used to measure mobility. The time required to stand up from a chair, walk 3 m to the line on the floor at a normal pace, walk back to the chair and sit down is measured (Thrane et al 2007)
4 weeks
Berg Balance Scale
Time Frame: 4 weeks
The Berg Balance Scale (BBS) consists of 14 simple balance related tasks that measure the static, dynamic, and functional balance skills (Sahin et al 2008)
4 weeks
Falls Efficacy Scale
Time Frame: 4 weeks
Tinetti's Falls Efficacy Scale (FES), which was used to assess fall-related self-efficacy, is a 10-questions scale (Scheffer et al 2008).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E.4629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data for other researches

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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