NCT03614182

Brief Summary

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of simultaneous or sequential combination of physical and cognitive training on dual-task walking and cognitive performance for community-dwelling healthy older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration 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

First Submitted

Initial submission to the registry

July 31, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

July 31, 2018

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • gait speed

    Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary gait parameter is gait speed (cm/s) under dual-task walking conditions using the 10 Meter Walking Test,

    5 minutes

  • composite score

    A composite score for cognitive-task performance will be calculated by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy trade-offs in the overall dual-task effect.

    10 minutes

Secondary Outcomes (9)

  • Berg Balance Scale (BBS).

    5-10 minutes

  • Mini-Balance Evaluation Systems Test (Mini-BESTest).

    10 minutes

  • Timed Up and Go Test (TUG).

    2 minutes

  • Functional Gait Assessment (FGA).

    10 minutes

  • Physical Activity Scale for the Elderly (PASE).

    5 minutes

  • +4 more secondary outcomes

Study Arms (3)

physical training concurrent with cognitive training

EXPERIMENTAL

The physical training concurrent with cognitive training group (the P+C group) will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Device: physical training concurrent with cognitive training

physical training followed by cognitive training

ACTIVE COMPARATOR

The physical training followed by cognitive training will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Device: physical training followed by cognitive training

physical training without cognitive training

ACTIVE COMPARATOR

The physical training without cognitive training group will receive training at progressively increasing task difficulty 3 times a week for 12 weeks and followed by another 12 weeks without exercise (follow-up).

Device: physical training without cognitive training

Interventions

The P+C group will undertake standing balance, stepping, and treadmill walking training while concurrently perform cognitive tasks.

Also known as: P+C
physical training concurrent with cognitive training

The P-then-C group will train the same set of standing balance, stepping, and treadmill walking activities as the P+C group while followed by cognitive training later.

Also known as: P-then-C
physical training followed by cognitive training

The P group will only train the same set of standing balance, stepping, and treadmill walking activities as the other two groups.

Also known as: P
physical training without cognitive training

Eligibility Criteria

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

You may qualify if:

  • age more than 65 years old
  • able to walk 10 m;
  • no severe vision, hearing, cognition, and language problems.

You may not qualify if:

  • neurological or musculoskeletal diagnosis that affects walking
  • unable standing for at least 2 minutes,
  • MMSE score \<24 or severe uncorrected visual deficits
  • moderate to severe high blood pressure (systolic pressure ≧ 160mmHg and diastolic blood pressure ≧ 100mmHg )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Interventions

Cognitive TrainingPrecision Medicine

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 3, 2018

Study Start

August 6, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations