NCT03981692

Brief Summary

The aim of our study is to investigate the effect of integrated and consecutive dual-task exercise trainings in elderly people on the balance, fear of falling and gait performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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

April 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

June 16, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

June 7, 2019

Last Update Submit

June 11, 2021

Conditions

Keywords

ElderlyBalanceGait speedCognitiveDual task

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale (BBS)

    The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities, named after Katherine Berg, one of the developers. For functional balance tests, the BBS is generally considered to be the gold standard. The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores. Minimum score is 0 while maximum score is 56. The classification; 0-20 scores - wheelchair user, 21-44 scores - walking with assistance 45-56 scores - independent. The test was performed at baseline and after Intervention (8 weeks)

    15 minutes

Secondary Outcomes (5)

  • Timed Up and Go test (TUGST)

    5 minutes

  • Timed Up and Go test Cognitive (TUGCOG)

    5 minutes

  • 10 Meters Walking Test Under Dual Task Condition (10MWTDT)

    5 minutes

  • 10 Meters Walking Test Under Single Task Condition (10MWTST)

    5 minutes

  • Tinetti Falls Efficacy Scale (FES)

    5 minutes

Study Arms (2)

Consecutive Dual Task Training

ACTIVE COMPARATOR

Sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. Immediately after these trainings, they should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run.

Other: Consecutive dual task

Integrated Dual Task Training

ACTIVE COMPARATOR

Sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given to the group. They will be done similar cognitive activities during with this simple balance trainings.

Other: Integrated dual task

Interventions

8 weeks and 2 days per week, one session 45 min. Consecutive dual task creates the idea that it may provide more workable work without creating stress while doing secondary task during dual task.

Consecutive Dual Task Training

8 weeks and 2 days per week, one session 45 min. Integrated dual task is a proven mode of work that has positive effects on geriatrics

Integrated Dual Task Training

Eligibility Criteria

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

You may qualify if:

  • Accepts to start routine exercise programs under the supervision of the medical team,
  • Over age 65,
  • Does not have orthopedic problems that may prevent him from exercising,
  • The MOCA score is 21 or higher,
  • Participants who have no other neurological problems that may cause loss of balance will be taken.

You may not qualify if:

  • Having orthopedic problems that prevent him from exercising,
  • Being under the MOCA score 21,
  • To have any neurological problem that will affect the balance,
  • Not wanting to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darüşşafaka Physical Therapy and Rehabilitation Center

Istanbul, Maltepe, 34848, Turkey (Türkiye)

Location

Related Publications (1)

  • Yuzlu V, Oguz S, Timurtas E, Aykutoglu E, Polat MG. The Effect of 2 Different Dual-Task Balance Training Methods on Balance and Gait in Older Adults: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab298. doi: 10.1093/ptj/pzab298.

Study Officials

  • Volkan Yüzlü, PT MSc

    Darüşşafaka Physical Therapy and Rehabilitation Center

    PRINCIPAL INVESTIGATOR
  • Semra Oğuz, PhD

    Marmara University

    STUDY DIRECTOR
  • Mine Gülden Polat, Prof PhD

    Marmara University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In the study; sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in a straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups. Group 1: Integrated Dual Task Training Group performed balance and cognitive tasks simultaneously. Group 2: Consecutive Dual Task Training Group performed balance and cognitive tasks sequentially. The cognitive tasks; They were expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week, etc. Attention, memory and arithmetic training will be given the ability to run.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 11, 2019

Study Start

April 8, 2019

Primary Completion

June 3, 2019

Study Completion

June 24, 2019

Last Updated

June 16, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations