NCT05333172

Brief Summary

Aging is a dynamic process that affects motor and cognitive functions. Activities of daily living and functionality, including dual task performance, are also negatively affected by these functions. The purpose of this study is to determine of balance training with dual task on cognitive function and functionality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2016

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 12, 2022

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Mini-Mental Status Examination (MMSE)

    Cognitive Functioning Test

    7 minutes

  • The Functional Independence Measure (FIM)

    Functionality Test

    10 minutes

Secondary Outcomes (6)

  • The Berg Balance Scale (BBS)

    5 minutes

  • The "Timed Up and Go" test (TUG)

    3 minutes

  • Timed sit to stand test (TSST)

    2 minutes

  • Ten meters walk test (TMTWT)

    3 minutes

  • Tinetti Performance Oriented Mobility Assessment(POMA)

    15 minutes

  • +1 more secondary outcomes

Study Arms (2)

balance exercise group

ACTIVE COMPARATOR

The balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues.

Other: Dual task exercises

Dual task exercises

EXPERIMENTAL

Dual task exercises are in two forms as motor dual task and cognitive dual task. In this study we used cognitive secondary task exercises. In addition to the exercises applied by the balance exercise group, a cognitive task was added. Participants in this group tried to count 4, 5 and 7 back from 100 while practicing balance exercises. The balance program was performed on soft and hard surface. Firstly the participants started the exercises on hard ground while standing. Postural balance program consisted of static and dynamic functional balance exercises (hıp flexion, hıp abduciton, semitandem stance, one leg stance, toe tips lifting). Afterwards exercises were performed on soft surface. Three sets of eight to ten repetitions of each exercise in a slow, controlled manner were performed. This section was completed 30 minitues.

Other: Dual task exercises

Interventions

Dual tasks, often also referred to as secondary tasks, present an objective-direct measurement in which two tasks are to be performed simultaneously to observe performance drops in either task.

Also known as: balance exercise group
Dual task exercisesbalance exercise group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being between the ages of 65-85
  • Being able to communicate
  • Able to walk without mobility aids
  • Be volunteer for intervention

You may not qualify if:

  • Cognitive impairment (\<17 point on the Minimal Mental State Examination )
  • In physiotherapy treatment that trains balance
  • Balance impairment (\< 20 point on the berg balance test)
  • having an orthopedic problem that may affect balance performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğçe Poyraz Işleyen

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 18, 2022

Study Start

June 1, 2016

Primary Completion

September 28, 2016

Study Completion

October 28, 2016

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations