Clinical trial NCT06573658: Neurophysiological Changes After Perturbation-based Training in Older Adults
Official title: Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Postural Balance
Falling
Keywords: Perturbation
Magnetic Resonance Image
MRI
step training
Falls
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to PBT or active control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to perturbation-based training (PBT) or active control. Neurophysiological changes in the brain following PBT compared to control will be investigated.

Detailed description: A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or active control. Written informed consent will be obtained from participants before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenient sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during the treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioral and MRI findings will be examined before and after training to identify training-induced changes in postural stability and structures and functional connectivities in the brain. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 60 years old
* Community-dwelling
* Right-handed
* Able to communicate effectively in Cantonese or Mandarin
* Able to walk independently on level ground for ≥ 30 minutes
* Abbreviated Mental Test (Hong Kong version) score ≥ 6

Exclusion Criteria:

* Metal implants (e.g. pacemaker, artificial cochlea)
* Uncorrected vision or hearing impairment
* Osteoporosis
* Hip or knee replacement within the last year
* Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.

Primary outcomes:
measure: Gray matter density in arbitrary units by structural Magnetic Resonance Imaging
timeFrame: pre-intervention, and immediately after the intervention
measure: Brain connectivity derived from the correlation between the Blood-oxygen-level-dependent (BOLD) signals from different brain regions in arbitrary units obtained during functional MRI
timeFrame: pre-intervention, and immediately after the intervention
Secondary outcomes:
measure: Postural stability
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Number of laboratory-falls
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Number of real-life-falls
timeFrame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
measure: Step time of the recovery steps in milliseconds (ms)
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Step length of the recovery steps in millimeters (mm)
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Trunk angle
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Hip height in millimeters (mm)
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Responsive postural adjustment upon translation
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Responsive postural adjustment upon tilting
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Muscle activation onset latency in milliseconds
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention
measure: Balance confidence
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up
measure: Cognitive flexibility and executive function
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
measure: Functional lower body strength
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
measure: Dynamic balance
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
measure: Mobility
timeFrame: pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention
measure: White matter density in arbitrary units by structural Magnetic Resonance Imaging
timeFrame: pre-intervention, and immediately after the intervention
measure: Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
timeFrame: pre-intervention, and immediately after the intervention
measure: White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)
timeFrame: pre-intervention, and immediately after the intervention
measure: Cortical thickness in mm measured by structural Magnetic Resonance Imaging
timeFrame: pre-intervention, and immediately after the intervention
measure: Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging
timeFrame: pre-intervention, and immediately after the intervention
measure: Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging
timeFrame: pre-intervention, and immediately after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Sau Lan Tsang, PhD
role: PRINCIPAL_INVESTIGATOR
References: