Clinical trial NCT03886805: The Dual-task Training Under Different Priority Instructions on Gait Speed in Community-dwelling Older Adults
Official title: The Effectiveness of Dual-task Training With Variable- and Fixed-priority Instructions on Gait Speed in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait
Postural Balance
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Although dual-task training for improving postural balance is an emerging interest area, the effects of dual tasks and dual-task training on static and dynamic postural stability remain unclear. Even though variable (alternating) instructional priority dual-task training has been shown higher effect than fixed (concurrent) priority dual-task training approach to improving the balance impairments, we must consider in everyday pragmatic situations, motor, and cognitive tasks are often demanded simultaneously and this requires an individual's attention toward an external source of attention while performing a primary task. Then, our rationale for this study is older adults who underwent a training protocol composed of a dual task with variable and fixed instructional priority will achieve better improvements regarding the studied variables in comparison to the group who will be submitted a protocol composed only by dual-task with variable priority training. Therefore, this protocol for a six-month, double-blind, randomized controlled trial with six-month follow-up post-training analyzed whether examine whether a dual-task protocol training with progression from variable priority to fixed priority instructions is effective in improvement of gait biomechanics, postural balance, falls episodes, executive functioning and quality of life in community-dwelling older adults.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Gait spatiotemporal variables
timeFrame: Post-randomization at week 12
measure: Gait spatiotemporal variables
timeFrame: Post-randomization at week 24
measure: Gait spatiotemporal variables
timeFrame: Post-intervention at week 12
measure: Gait spatiotemporal variables
timeFrame: Post-intervention at week 24
Secondary outcomes:
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
timeFrame: Post-radomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
timeFrame: Post-intervention at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
timeFrame: Post-randomization at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
timeFrame: Post-randomization at week 24
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
timeFrame: Post-intervention at week 12
measure: Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
timeFrame: Post-intervention at week 24
measure: Timed Up and Go conventional (TUG conventional)
timeFrame: Post-randomization at week 12
measure: Timed Up and Go conventional (TUG conventional)
timeFrame: Post-randomization at week 24
measure: Timed Up and Go conventional (TUG conventional)
timeFrame: Post-intervention at week 12
measure: Timed Up and Go conventional (TUG conventional)
timeFrame: Post-intervention at week 24
measure: Timed Up and Go manual (TUG manual)
timeFrame: Post-randomization at week 12
measure: Timed Up and Go manual (TUG manual)
timeFrame: Post-randomization at week 24
measure: Timed Up and Go manual (TUG manual)
timeFrame: Post-intervention at week 12
measure: Timed Up and Go manual (TUG manual)
timeFrame: Post-intervention at week 24
measure: Timed Up and Go cognitive (TUG cognitive)
timeFrame: Post-randomization at week 12
measure: Timed Up and Go cognitive (TUG cognitive)
timeFrame: Post-randomization at week 24
measure: Timed Up and Go cognitive (TUG cognitive)
timeFrame: Post-intervention at week 12
measure: Timed Up and Go cognitive (TUG cognitive)
timeFrame: Post-intervention at week 24
measure: Postural Balance Test (PBT)
timeFrame: Post-randomization at week 12
measure: Postural Balance Test (PBT)
timeFrame: Post-randomization at week 24
measure: Postural Balance Test (PBT)
timeFrame: Post-intervention at week 12
measure: Postural Balance Test (PBT)
timeFrame: Post-intervention at week 24
measure: Clinical Test of Sensory Interaction and Balance (CTSIB)
timeFrame: Post-randomization at week 12
measure: Clinical Test of Sensory Interaction and Balance (CTSIB)
timeFrame: Post-randomization at week 24
measure: Clinical Test of Sensory Interaction and Balance (CTSIB)
timeFrame: Post-intervention at week 12
measure: Clinical Test of Sensory Interaction and Balance (CTSIB)
timeFrame: Post-intervention at week 24
measure: Stroop test in sit posture
timeFrame: Post-randomization at week 12
measure: Stroop test in sit posture
timeFrame: Post-randomization at week 24
measure: Stroop test in sit posture
timeFrame: Post-intervention at week 12
measure: Stroop test in a quasi-static standing posture
timeFrame: Post-intervention at week 24
measure: Trail making test (TMT)
timeFrame: Post-randomization at week 12
measure: Trail making test (TMT)
timeFrame: Post-randomization at week 24
measure: Trail making test (TMT)
timeFrame: Post-intervention at week 12
measure: Trail making test (TMT)
timeFrame: Post-intervention at week 24
measure: Five Times Sit-to-Stand test from a chair
timeFrame: Post-randomization at week 12
measure: Five Times Sit-to-Stand test from a chair
timeFrame: Post-randomization at week 24
measure: Five Times Sit-to-Stand test from a chair
timeFrame: Post-intervention at week 12
measure: Five Times Sit-to-Stand test from a chair
timeFrame: Post-intervention at week 24
measure: Sitting-and-rising test from the floor
timeFrame: Post-randomization at week 12
measure: Sitting-and-rising test from the floor
timeFrame: Post-randomization at week 24
measure: Sitting-and-rising test from the floor
timeFrame: Post-intervention at week 12
measure: Sitting-and-rising test from the floor
timeFrame: Post-intervention at week 24
measure: Anterior functional reach test
timeFrame: Post-randomization at week 12
measure: Anterior functional reach test
timeFrame: Post-randomization at week 24
measure: Anterior functional reach test
timeFrame: Post-intervention at week 12
measure: Anterior functional reach test
timeFrame: Post-intervention at week 24
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Post-randomization at week 12
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Post-randomization at week 24
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Post-intervention at week 12
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Post-intervention at week 24
measure: Activities-specific Balance Confidence (ABC Scale)
timeFrame: Post-randomization at week 12
measure: Activities-specific Balance Confidence (ABC Scale)
timeFrame: Post-randomization at week 24
measure: Activities-specific Balance Confidence (ABC Scale)
timeFrame: Post-intervention at week 12
measure: Activities-specific Balance Confidence (ABC Scale)
timeFrame: Post-intervention at week 24
measure: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: Post-randomization at week 12
measure: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: Post-randomization at week 24
measure: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: Post-intervention at week 12
measure: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: Post-intervention at week 24
measure: Short form of the Geriatric Depression Scale (GDS-15)
timeFrame: Post-randomization at week 12
measure: Short form of the Geriatric Depression Scale (GDS-15)
timeFrame: Post-randomization at week 24
measure: Short form of the Geriatric Depression Scale (GDS-15)
timeFrame: Post-intervention at week 12
measure: Short form of the Geriatric Depression Scale (GDS-15)
timeFrame: Post-intervention at week 24
measure: The falls events
timeFrame: Post-randomization at week 12
measure: The falls events
timeFrame: Post-randomization at week 24
measure: The falls events
timeFrame: Post-intervention at week 12
measure: The falls events
timeFrame: Post-intervention at week 24
Other outcomes:
Locations:
city: Petrolina
country: Brazil
facility: Francis Trombini de Souza
state: Pernambucano
Study officials:
affiliation: University of Pernambuco
name: Francis T de Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.