NCT07393516

Brief Summary

This clinical trial aims to investigate the effects of variable-priority dual-task training on balance, gait, and quality of life in Chinese elderly women, exploring more effective training methods to help healthy elderly women improve balance and gait performance, reduce fall rates, and enhance quality of life. The trial primarily seeks to address the following questions: H01: Between the three intervention groups (VPDT, FPDT, and PT), there are no statistically significant differences in balance among healthy older Chinese women at baseline (T1), week 6 (T2), or week 12 (T3). H02: Between the three intervention groups (VPDT, FPDT, and PT), there are no statistically significant differences in gait among healthy older Chinese women at baseline (T1), week 6 (T2), or week 12 (T3). H03: Between the three intervention groups (VPDT, FPDT, and PT), there are no statistically significant differences in QoL among healthy older Chinese women at baseline (T1), week 6 (T2), or week 12 (T3). Researchers will compare variable-priority dual-task training with a placebo (fixed-priority dual-task training and physical training) to determine whether variable-priority dual-task training effectively improves balance, gait, and quality of life in Chinese elderly women. Participants will: Undergo three 60-minute training sessions per week for 12 weeks; Each session combines concurrent cognitive and physical training, with slight variations in content across the three groups; Outcome measurements will be taken at baseline, week 6 post-intervention, and week 12 post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

BalanceGaitOlder adultsQuality of lifedual-task trainingVariable-priority dual-task training

Outcome Measures

Primary Outcomes (8)

  • Dual-Task 10-Meter Walk Test

    From enrollment to the end of treatment at 12 weeks

  • 10-Meter Walk Test

    From enrollment to the end of treatment at 12 weeks

  • Timed Up and Go Test

    From enrollment to the end of treatment at 12 weeks

  • Dual-Task Timed Up and Go Test

    From enrollment to the end of treatment at 12 weeks

  • Five Times Sit-to-Stand Test

    From enrollment to the end of treatment at 12 weeks

  • Single-Legged Closed-Eyed Standing Test

    From enrollment to the end of treatment at 12 weeks

  • Berg Balance Scale

    From enrollment to the end of treatment at 12 weeks

  • Activities-Specific Balance Confidence Scale

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

  • 36-Item Short Form of Health Survey

    From enrollment to the end of treatment at 12 weeks

Study Arms (3)

Variable-priority dual-task training

EXPERIMENTAL

Variable priority dual-task training requires participants to perform cognitive-motor dual-task training while adjusting attention priorities based on instructions such as "posture priority" or "cognitive priority." During training, the coach monitored behaviour for adherence to the instructed priority (e.g., excessive stopping to respond during cognitive-priority bouts, reduced responding/ignoring prompts during cognitive-priority bouts, or unsafe postural behaviour during posture-priority bouts). When deviations were observed, standardized corrective prompts were delivered immediately and the priority instruction was restated. Cognitive-task performance (correct/total responses) was recorded for each bout as an adherence indicator of engagement with the instructed attentional priority. Marked accuracy deterioration or obvious non-compliance triggered real-time coaching prompts to restore the intended priority strategy while maintaining safe postural control.

Behavioral: Variable-Priority Cognitive-Motor Dual-Task Training

Fixed-priority dual-task training

ACTIVE COMPARATOR

Fixed-priority dual-task training requires participants to perform cognitive-motor dual-task training simultaneously. At the beginning of each session and before each motor-task set, participants were instructed to "pay equal attention to the motor and cognitive tasks throughout," aiming to maintain safe, stable movement while responding as accurately as possible. Participants were asked to repeat the instruction in their own words to confirm understanding. During training, the coach monitored behaviour for signs of disproportionate prioritization (e.g., pausing the motor task to answer, ignoring the cognitive prompt, or unsafe postural behaviour). Standardized reminders (e.g., "keep both tasks equally important") were delivered when needed. Cognitive responses were checked in real time, and incorrect responses were corrected immediately to reinforce engagement with the cognitive task while maintaining safe postural control.

Behavioral: Fixed-Priority Cognitive-Motor Dual-Task Training

Phsical training

ACTIVE COMPARATOR

The PT group first performed a 10-minute warm-up exercise. Then, in the order of the exercise tasks, they performed sit-ups, stand-ups, seated rowing, object transfer, obstacle avoidance, and connected walking training. Finally, a 10-minute relaxation activity was performed. Session duration, weekly frequency, and supervision were matched across the VPDT and FPDT groups, but PT consisted only of single-task exercises (no cognitive tasks or priority instructions).

Behavioral: Phsical training

Interventions

Intervention Description (VPDT): Participants will receive variable-priority cognitive-motor dual-task training (VPDT) for 12 weeks. Training will be delivered in supervised sessions 3 times/week, 60 minutes/session, in a small group format. Each session combines functional balance and gait tasks (e.g., sit-to-stand, obstacle negotiation, line walking, turning, transfers) with concurrent cognitive tasks (e.g., serial subtraction/1-back/semantic fluency). Variable-priority instructions are used: participants are coached to flexibly shift attention between the motor and cognitive task across repetitions/blocks, with individualized cueing. Attendance is recorded each session; adverse events are monitored and managed according to a predefined safety protocol.

Variable-priority dual-task training

Intervention Description (FPDT): Participants will receive fixed-priority cognitive-motor dual-task training (FPDT) for 12 weeks, supervised 3 times/week, 60 minutes/session. The motor tasks and cognitive tasks are matched to the VPDT group in type and total practice time. Fixed-priority instructions are used: participants are instructed to maintain equal and consistent attention to both tasks simultaneously throughout training, without shifting priorities across blocks. Progression and safety monitoring follow the same principles as VPDT. Attendance and adverse events are documented.

Fixed-priority dual-task training

The PT group first performed a 10-minute warm-up exercise. Then, in the order of the exercise tasks, they performed sit-ups, stand-ups, seated rowing, object transfer, obstacle avoidance, and connected walking training. Finally, a 10-minute relaxation activity was performed. Session duration, weekly frequency, and supervision were matched across the VPDT and FPDT groups, but PT consisted only of single-task exercises (no cognitive tasks or priority instructions).

Phsical training

Eligibility Criteria

Age65 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • (1) age ≥65 years; (2) no severe visual or hearing impairments; (3) no limb disabilities or physical mobility impairments, able to stand and walk independently without the use of walking aids; (4) no neurological diseases or cognitive impairment; (5) MoCA score ≥26; (6) informed consent and voluntary participation.

You may not qualify if:

  • (1) severe cardiovascular, pulmonary, or musculoskeletal system diseases; (2) neurological diseases severely affecting balance function, such as stroke or Parkinson's disease; (3) mental illnesses such as depression or use of psychiatric medications; (4) need for assistive devices for walking; (5) simultaneous participation in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinheyuan Community Senior Citizens Activity Center, Hongshan District

Wuhan, Hubei, 430070, China

Location

Related Publications (5)

  • 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.

  • Effect of agility training under single-task condition versus training under dual-task condition with different task priorities to improve balance in the elderly.

    RESULT
  • Lussier M, Bugaiska A, Bherer L. Specific transfer effects following variable priority dual-task training in older adults. Restor Neurol Neurosci. 2017;35(2):237-250. doi: 10.3233/RNN-150581.

  • Silsupadol P, Shumway-Cook A, Lugade V, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Effects of single-task versus dual-task training on balance performance in older adults: a double-blind, randomized controlled trial. Arch Phys Med Rehabil. 2009 Mar;90(3):381-7. doi: 10.1016/j.apmr.2008.09.559.

  • Sengar S, Raghav D, Verma M, Alghadir AH, Iqbal A. Efficacy Of Dual-Task Training With Two Different Priorities Instructional Sets On Gait Parameters In Patients With Chronic Stroke. Neuropsychiatr Dis Treat. 2019 Oct 17;15:2959-2969. doi: 10.2147/NDT.S197632. eCollection 2019.

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
SPONSOR INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

November 5, 2023

Primary Completion

June 10, 2024

Study Completion

June 18, 2024

Last Updated

February 6, 2026

Record last verified: 2026-01

Locations