NCT02280928

Brief Summary

The purpose of this study is to (1) develop and test the effectiveness of home-based interventions on dual-task performance in older adults; and (2) determine the generalizability of the four trainings (i.e. single-task motor training, single-task cognitive training, dual-task motor-cognitive training, and dual-task cognitive-cognitive trainings) to novel tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

October 30, 2014

Last Update Submit

July 21, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Center of Mass velocity and Base of Support distance

    The Center of Mass velocity and Base of Support distance is referred as the direction of the center of mass velocity in relation to base of support. It is used to measure the control of dynamic balance throughout gait under single-task and dual-task conditions in order to examine training effect.

    At baseline and after 4-week training

  • Spatio-temporal gait parameters

    Spatio-temporal gait parameters is measured throughout gait under single-task and dual-task conditions in order to examine training effect.

    At baseline and after 4-week training

Study Arms (4)

Single-task motor training group

EXPERIMENTAL

The participants will receive only balance training which will progress from stance activities, to stance activities plus hand manipulation, then gait activities, and finally gait activities plus hand manipulation.

Other: Balance exercise

Single-task cognitive training group

EXPERIMENTAL

The participants will receive cognitive training that will involve executive function, attention, and working memory.

Other: Cognitive training

Dual-task motor-cognitive training group

EXPERIMENTAL

The participants assigned to the dual-task motor-cognitive training group will receive the same exercises as single-task motor training while simultaneously performing secondary tasks as those in the single-task cognitive training group.

Other: Balance exerciseOther: Cognitive training

Dual-task cognitive-cognitive training group

EXPERIMENTAL

The participants in the dual-task cognitive-cognitive trainings group will receive two cognitive tasks at the same time.

Other: Dual-task cognitive-cognitive training

Interventions

Balance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation.

Dual-task motor-cognitive training groupSingle-task motor training group

Cognitive training involves executive function, attention, and working memory. Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills.

Dual-task motor-cognitive training groupSingle-task cognitive training group

The Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time.

Dual-task cognitive-cognitive training group

Eligibility Criteria

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

You may qualify if:

  • Able to walk at least 10 meters without any assistive device
  • Having greater than 16/23 for illiterate persons, greater than 20/30 for primary education level persons, and greater than 23/30 for secondary education level persons on the Mini-Mental State Examination-Thai 2002 (MMSE-Thai2002)

You may not qualify if:

  • Severe neurological problems that could account for possible imbalance such as cerebral vascular accident, Parkinson's disease, transient ischemic attacks, and neuropathy
  • Severe musculoskeletal problems that could impact gait such as severe osteoarthritis and active inflammatory joint disease
  • Severe cardiopulmonary problems such as asthma and chronic obstructive pulmonary disease
  • Visual impairment that cannot be corrected by lenses
  • Severe auditory impairment such as deafness
  • Depression as scored ≥ 13 by Thai Geriatric Depression Scale (TGDS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Associated Medical Sciences, Chiang Mai University

Sripoom, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Interventions

Cognitive Training

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
Faculty of Associated Medical Sciences

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 3, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations