Older Adults With a History of FallsNCT06378164
The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers
A study testing Exercise in people with Older Adults With a History of Falls, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults With a History of Falls
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling
- Able to walk for 1 minute under supervision without walking aids
- Have a history of falling in the past year
Who cannot join
- Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
- Blindness
- Neurological conditions (e.g., stroke, Parkinson's disease)
- Other serious illnesses that preclude participation in exercise training
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Freddy Man Hin LAM, PhD, 27666720, freddy-mh.lam@polyu.edu.hk
Freddy Man Hin LAM
About this study
Official title: The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial
To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.
- Conditions
- Older Adults With a History of Falls
- Being tested
- Exercise, Active Control
- Keywords
- Falls, Exercise, Randomised Trial, Step Training, Reaction
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
For the combined step training group, the participants will receive training on both volitional and reactive stepping. The training will last for 1 hours per session, 2 session per week for 4 weeks.
Active ControlBehavioural
An active control group will be used to minimise the placebo and history effect. The group will also receive a 4-week programme with the frequency and duration of the training and the instructor-to-participant ratio that match the combined step training group. During training, they will perform exercises not specific to reducing fall risk.
| Study group | Role | What they receive |
|---|---|---|
| Combined volitional and reactive step training | Experimental | Not described Receives: Behavioral: Exercise |
| Non-specific exercise group | Placebo comparator | Not described Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice Stepping Reaction Times
To assess volitional stepping performance
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Spring Scale Test
To assess reactive stepping performance
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Secondary outcomes (7)
Mini Balance Evaluation System Test
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Motor Control Test
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Falls Efficacy Scale - International
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Trail-Making Test
Measured: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Programme Adherence
The attendance of the exercise class will be recorded.
Measured: From start to six months after the end of training
Prospective Falls
Fall incidence and details on fall will be recorded using a fall diary and monthly follow-up.
Measured: From start to 12 months after the intervention ends
Adverse Events
Adverse events happened during the intervention will be recorded descriptively.
Measured: From start to six months after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Dec 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults With a History of FallsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Neuroscience Research Australia, The University of New South Wales
- Responsible party
- Principal investigator, Freddy Man Hin LAM, The Hong Kong Polytechnic University
- Investigators
- Freddy Man Hin LAM, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378164
- Sponsor's protocol ID
- P0041406
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data can be provided via contacting the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06378164
- Acronym / sponsor ID
- P0041406
- Conditions
- Older Adults With a History of Falls
- Keywords
- Falls, Exercise, Randomised Trial, Step Training, Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Neuroscience Research Australia, The University of New South Wales
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined volitional and reactive step training | Experimental | Behavioral: Exercise |
| Non-specific exercise group | Placebo comparator | Behavioral: Active Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Community-dwelling
- Able to walk for 1 minute under supervision without walking aids
- Have a history of falling in the past year
Key exclusion criteria (4 listed)
- Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
- Blindness
- Neurological conditions (e.g., stroke, Parkinson's disease)
- Other serious illnesses that preclude participation in exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseFor the combined step training group, the participants will receive training on both volitional and reactive stepping. The training will last for 1 hours per session, 2 session per week for 4 weeks. | Behavioural | Combined volitional and reactive step training |
| Active ControlAn active control group will be used to minimise the placebo and history effect. The group will also receive a 4-week programme with the frequency and duration of the training and the instructor-to-participant ratio that match the combined step training group. During training, they will perform exercises not specific to reducing fall risk. | Behavioural | Non-specific exercise group |
Primary outcome
Choice Stepping Reaction Times
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess volitional stepping performance
Spring Scale Test
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess reactive stepping performance
7 secondary outcomes
Mini Balance Evaluation System Test
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Motor Control Test
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Falls Efficacy Scale - International
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Trail-Making Test
Time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Programme Adherence
Time frame: From start to six months after the end of training
Prospective Falls
Time frame: From start to 12 months after the intervention ends
Adverse Events
Time frame: From start to six months after the end of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes. The study data can be provided via contacting the Principal Investigator
Related trials for Older Adults With a History of Falls
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Enrolling by invitation
Occupation-Based Multicomponent Intervention to Reduce Fall Risk in Older Adults
Geriatric, Fall
Not yet recruitingObservational study
Incidence and Factors of Functional Decline After Emergency Department Discharge in Older Adults With Falls
Fall, Daily Activities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Man Hin LAM, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Older Adults With a History of Falls, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Freddy Man Hin LAM, PhD (2766 6720, freddy-mh.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice Stepping Reaction Times (time frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.