Mild Cognitive ImpairmentFallsPACTNCT03167840
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
A study testing Physical and Cognitive Training, Physical Training and Cognitive training in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Philippines.
Trial summary
This randomised controlled trial aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Physical and Cognitive Training, Physical Training and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 sitePhilippines
- Study dates
- 6 Sep 2017to 31 Aug 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or above
- community-dwelling in Manila, Philippines
- diagnosed with MCI
Who cannot join
- diagnosis of dementia or Alzheimer's disease
- history of major medical conditions such as cerebrovascular disease, cardiopulmonary condition, serious musculoskeletal disease, cancer, major psychiatric condition
- have severe visual and/or hearing impairment
- taking medications such sedatives, antidepressants, diuretics, anti-epilepsy.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
University of Santo Tomas
Manila, National Capital Region, 1015
About this study
Official title: Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
This randomised controlled trial aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with mild cognitive impairment (MCI).
Read the detailed description
This is a single-blind, multicentre, randomised controlled trial. Community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and wait-list group (WG). Assessors blinded to participant allocation will conduct pre-test, posttest, and 6-month follow-up assessments.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Physical and Cognitive Training, Physical Training, Cognitive training
- Keywords
- falls prevention, older adults, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and Cognitive TrainingBehavioural
Also called Integrated cognitive training in physical exercise
Physical Exercise and Cognitive Training
Physical TrainingBehavioural
Also called Physical exercise
Physical training alone
Cognitive trainingBehavioural
Also called Mental exercise
Cognitive training alone
| Study group | Role | What they receive |
|---|---|---|
| Physical training alone (PT) | Experimental | Physical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity. Receives: Behavioral: Physical Training |
| Cognitive training alone (CT) | Experimental | Cognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks. Receives: Behavioral: Cognitive training |
| Physical and cognitive training (PACT) | Experimental | Integrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks. Receives: Behavioral: Physical and Cognitive Training |
| Wait-list group (WG) | No intervention | The control group on wait-list. They will be instructed to go on with their usual activities and will receive the intervention, combined physical and cognitive training, at a later date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Rate
Number of Falls over a period of time
Measured: 9 months
Secondary outcomes (8)
Change in Physiologic Profile Assessment (PPA) score
Physiologic risk for falls
Measured: Baseline, 3 months, 9 months
Change in Falls Risks for Older People in the Community (FROP-Com) Screen score
Overall fall risk
Measured: Baseline, 3 months, 9 months
Change in Global Cognitive Function
Montreal Cognitive Assessment (MoCA)
Measured: Baseline, 3 months, 9 months
Change in Memory Function
Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS)
Measured: Baseline, 3 months, 9 months
Change in Executive Function
Executive Function Performance Test (EFPT)
Measured: Baseline, 3 months, 9 months
Change in Balance
Time Up and Go Test (TUGT)
Measured: Baseline, 3 months, 9 months
Change in Gait Speed
10-Meter Walk Test (10MWT)
Measured: Baseline, 3 months, 9 months
Change in Muscle Strength
30s-Chair-Stand Test (CST)
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start6 Sep 2017
- Primary completion31 Jan 2018
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santo Tomas
- Responsible party
- Sponsor
- Investigators
- William Tsang, PhD, Principal investigator, The Hong Kong Polytechnic University - Department of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167840
- Sponsor's protocol ID
- HSEARS20170402001
- Acronym
- FallsPACT
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
PubMed 30143002
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls Prevention Through Physical And Cognitive Training (Falls PACT) in Older Adults With Mild Cognitive Impairment: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03167840
- Acronym / sponsor ID
- FallsPACT / HSEARS20170402001
- Conditions
- Mild Cognitive Impairment
- Keywords
- falls prevention, older adults, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of Santo Tomas
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 30 May 2017 (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.
This randomised controlled trial aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with mild cognitive impairment (MCI).
Detailed description
This is a single-blind, multicentre, randomised controlled trial. Community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and wait-list group (WG). Assessors blinded to participant allocation will conduct pre-test, posttest, and 6-month follow-up assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical training alone (PT) | Experimental | Behavioral: Physical TrainingPhysical Training (flexibility, endurance, strengthening, and balance training) for 60-90 minutes 3x/week over 12 weeks of moderate intensity. |
| Cognitive training alone (CT) | Experimental | Behavioral: Cognitive trainingCognitive training with a focus on orientation, memory, attention and executive functioning for 60-90 minutes per session, once per week for 12 weeks. |
| Physical and cognitive training (PACT) | Experimental | Behavioral: Physical and Cognitive TrainingIntegrated cognitive training in physical exercise for 60-90 minutes per session, 3x/week over 12 weeks. |
| Wait-list group (WG) | No intervention | –The control group on wait-list. They will be instructed to go on with their usual activities and will receive the intervention, combined physical and cognitive training, at a later date. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or above
- community-dwelling in Manila, Philippines
- diagnosed with MCI
Key exclusion criteria (4 listed)
- diagnosis of dementia or Alzheimer's disease
- history of major medical conditions such as cerebrovascular disease, cardiopulmonary condition, serious musculoskeletal disease, cancer, major psychiatric condition
- have severe visual and/or hearing impairment
- taking medications such sedatives, antidepressants, diuretics, anti-epilepsy.
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 |
|---|---|---|
| Physical and Cognitive TrainingAlso: Integrated cognitive training in physical exercisePhysical Exercise and Cognitive Training | Behavioural | Physical and cognitive training (PACT) |
| Physical TrainingAlso: Physical exercisePhysical training alone | Behavioural | Physical training alone (PT) |
| Cognitive trainingAlso: Mental exerciseCognitive training alone | Behavioural | Cognitive training alone (CT) |
Primary outcome
Falls Rate
Time frame: 9 months
Number of Falls over a period of time
8 secondary outcomes
Change in Physiologic Profile Assessment (PPA) score
Time frame: Baseline, 3 months, 9 months
Change in Falls Risks for Older People in the Community (FROP-Com) Screen score
Time frame: Baseline, 3 months, 9 months
Change in Global Cognitive Function
Time frame: Baseline, 3 months, 9 months
Change in Memory Function
Time frame: Baseline, 3 months, 9 months
Change in Executive Function
Time frame: Baseline, 3 months, 9 months
Change in Balance
Time frame: Baseline, 3 months, 9 months
Change in Gait Speed
Time frame: Baseline, 3 months, 9 months
Change in Muscle Strength
Time frame: Baseline, 3 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Derived from this study: PubMed 30143002Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
- Individual participant dataSharing planned: Undecided
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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.
William Tsang, PhD principal investigator
The Hong Kong Polytechnic University - Department of Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and Cognitive Training, Physical Training and Cognitive training in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Philippines.
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 27 Apr 2018. 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 Philippines. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167840, which also lists 1 linked publication.
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 27 Apr 2018; AzTrials last refreshed its copy on 30 Oct 2026.