NCT03886805

Brief Summary

This study analyzed the effect of different modalities of dual-task training in the improvement of gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. Half of the participants have undertaken a dual-task protocol training with progression from variable-priority to fixed-priority instructions, while the other half have undertaken a dual-task protocol training under variable-priority instructions.

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 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

First Submitted

Initial submission to the registry

March 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

March 12, 2019

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Gait spatiotemporal variables

    These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).

    Post-randomization at week 12

  • Gait spatiotemporal variables

    These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).

    Post-randomization at week 24

  • Gait spatiotemporal variables

    These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).

    Post-intervention at week 12

  • Gait spatiotemporal variables

    These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).

    Post-intervention at week 24

Secondary Outcomes (104)

  • Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task

    Post-randomization at week 12

  • Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task

    Post-radomization at week 24

  • Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task

    Post-intervention at week 12

  • Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task

    Post-intervention at week 24

  • Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction

    Post-randomization at week 12

  • +99 more secondary outcomes

Study Arms (2)

Dual task with variable- and fixed-priority instructions

EXPERIMENTAL

Sixty-minute training sessions, 2 times a week for 24 weeks. From the 1st to 12th week the participants were trained under variable-priority instructions (half the session was focused on balance motor task and half the session focused on cognitive task performance). From the 13th to 24th week) the participants performed dual tasks under fixed-priority instructions (simultaneous focus attention on balance and cognitive tasks). The motor tasks were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks will include activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, working memory, among other cognitive tasks.

Other: Dual task with variable- and fixed-priority instructions

Dual-task with variable-priority instructions

ACTIVE COMPARATOR

Sixty-minute training sessions, 2 times a week for 24 weeks (48 sessions). From the 1st to 24th week, the participants were trained under variable-priority instructions, in which they were asked to spend half the session focused on balance (motor task) and half the session focused on cognitive task performance. The motor tasks (gait and postural balance) of this protocol were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks included activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, rescue working memory, among other cognitive tasks.

Other: Dual-task with variable-priority instructions

Interventions

The participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist.

Dual task with variable- and fixed-priority instructions

The participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist.

Dual-task with variable-priority instructions

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of both sexes
  • Age between 60 and 80 years old
  • Participants with a score greater or equal to 52 (up to a maximum of 56) in the Berg Balance Scale
  • Participants with a score greater or equal to 24 (up to a maximum of 30) in the Mini-mental State Exam
  • Participants who are able to walk uninterruptedly for a distance of 10-meter at a self-selected velocity of at least 1.0 m/s without the need from another person, cane or walker

You may not qualify if:

  • Self-report of two or more falls in the last 12 months
  • Any contraindication to balance postural training
  • Any contraindication to cognitive exercise training
  • With self-report of two or more falls in the last 12 months
  • Who is participating or have participated, in the last 6 months, in any regular and structured physical exercise program, for 3 or more times per week
  • Any chronic health condition, including cardiovascular disease, respiratory disease, stroke, active cancer, neurological or neuromuscular conditions whose exercise is contraindicated
  • Any upper or lower limb fracture in the last 6 months
  • Evidence of any surgical procedures in the knees, ankles, and hips or muscle damage in the last 6 months
  • Uncontrolled diabetes.
  • No able to speak and understand the Portuguese language
  • Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francis Trombini de Souza

Petrolina, Pernambucano, 56302685, Brazil

Location

Related Publications (1)

  • Trombini-Souza F, de Maio Nascimento M, da Silva TFA, de Araujo RC, Perracini MR, Sacco ICN. Dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults: A protocol for a randomized controlled trial : Variable- and fixed-priority dual-task for older adults. BMC Geriatr. 2020 Feb 22;20(1):76. doi: 10.1186/s12877-020-1479-2.

Study Officials

  • Francis T de Souza, PhD

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 22, 2019

Study Start

April 30, 2019

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations