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Clinical Trials/NCT07393516
NCT07393516
Completed
Not Applicable

EFFECTS OF VARIABLE-PRIORITY DUAL-TASK TRAINING ON BALANCE, GAIT, AND QUALITY OF LIFE IN ELDERLY WOMEN IN CHINA

Yu Xiao1 site in 1 country75 target enrollmentStarted: November 5, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Yu Xiao
Enrollment
75
Locations
1
Primary Endpoint
Dual-Task 10-Meter Walk Test

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 90 Years (Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • (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.

Exclusion Criteria

  • (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.

Arms & Interventions

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.

Intervention: Variable-Priority Cognitive-Motor Dual-Task Training (Behavioral)

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.

Intervention: Fixed-Priority Cognitive-Motor Dual-Task Training (Behavioral)

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).

Intervention: Phsical training (Behavioral)

Outcomes

Primary Outcomes

Dual-Task 10-Meter Walk Test

Time Frame: From enrollment to the end of treatment at 12 weeks

10-Meter Walk Test

Time Frame: From enrollment to the end of treatment at 12 weeks

Timed Up and Go Test

Time Frame: From enrollment to the end of treatment at 12 weeks

Dual-Task Timed Up and Go Test

Time Frame: From enrollment to the end of treatment at 12 weeks

Five Times Sit-to-Stand Test

Time Frame: From enrollment to the end of treatment at 12 weeks

Single-Legged Closed-Eyed Standing Test

Time Frame: From enrollment to the end of treatment at 12 weeks

Berg Balance Scale

Time Frame: From enrollment to the end of treatment at 12 weeks

Activities-Specific Balance Confidence Scale

Time Frame: From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

  • 36-Item Short Form of Health Survey(From enrollment to the end of treatment at 12 weeks)

Investigators

Sponsor
Yu Xiao
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Yu Xiao

Phd

Universiti Putra Malaysia

Study Sites (1)

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