Cognitive DeclineMTCCPNCT04727450
Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults
A study testing Cognitive training, physical training and Combination of cognitive and physical training (CCPT)-BIGMAP in people with Cognitive Decline and Cognitive Impairment, Mild, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Impairment, Mild
- What is being tested?
- Cognitive training, physical training and Combination of cognitive and physical training (CCPT)-BIGMAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2021to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 or above
- Both gender
- Willingness and capability to participate in this study and training
- Willingness and capability to give informed consent to participate in this study
- Pass the cutting-point of referenced screening tests (cognitive and emotional)
- Screening tools:
- MOCA score above 19 (satisfactory basic function)
- Positive and Negative Syndrome Scale (PANSS) with scores < 19 in positive scale, < 22 in negative scale, and < 38 in general psychopathology scale
Who cannot join
- A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease
- Early stages of Alzheimer's Disease, or the use of psychoactive drugs
- Complicated conditions that preclude regular attendance of the training
- Currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer ).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong Baptist University
Hong Kong, 00852
Bik-Chu CHOW, PhD, +85234117007, bchow@hkbu.edu.hk
Jojo JIAO, PhD, +85234115758, jojojiao@hkbu.edu.hk
About this study
Official title: Effects of Multimodal Training of Combined Cognitive and Physical and Cognitive or Physical Training Only on Cognition and Physical Fitness of Older Adults: A Cluster Randomized Controlled Trial
The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. The purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training [CCPT], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in Hong Kong. The study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.
Read the detailed description
The study design is a cluster randomized controlled trial. Twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. A total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. Each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. Each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. Assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.
- Conditions
- Cognitive Decline, Cognitive Impairment, Mild
- Being tested
- Cognitive training, physical training, Combination of cognitive and physical training (CCPT)-BIGMAP
- Keywords
- Intervention programs, Older adults, Cognitive & Physical Training, Cluster RCT, Multimodal
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.
physical trainingBehavioural
Involves learning of preselected routines of "line dancing" taught by a line dance instructor.
Combination of cognitive and physical training (CCPT)-BIGMAPBehavioural
Also called "Brain Invigoration Gross Motor Activation Program" (BIGMAP)
BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu \& Chow, 2019).
| Study group | Role | What they receive |
|---|---|---|
| 1. Integrated format | Active comparator | Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT). Receives: Behavioral: Cognitive training; Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP |
| 2. Cognitive training + Physical Training (A+B) | Active comparator | Intervention of A \& B treatments. Receives: Behavioral: Cognitive training; Behavioral: physical training |
| 3. Physical training + CCPT (B+C) | Active comparator | Intervention of B \& C treatments. Receives: Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP |
| 4. CCPT + Cognitive training (C+A) | Active comparator | Intervention of C \& A treatments. Receives: Behavioral: Cognitive training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP |
| 5. Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Tests: for executive function (pre-test)
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: Pre-test (1st test): before intervention
Cognitive Tests: for executive function (2nd test)
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 2nd test: after 2-month intervention
Cognitive Tests: for executive function (3rd test)
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 3rd test: after 4-month intervention
Cognitive Tests: for executive function (4th test)
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 4th test: after 2-month follow up
Cognitive Tests: for attention (pre-test)
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: Pre-test (1st test): before intervention
Cognitive Tests: for attention (2nd test)
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 2nd test: after 2-month intervention
Cognitive Tests: for attention (3rd test)
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 3rd test: after 4-month intervention
Cognitive Tests: for attention (4th test)
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 4th test: after 2-month follow up
Cognitive Tests: for everyday memory (pre-test)
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: Pre-test (1st test): before intervention
Cognitive Tests: for everyday memory (2nd test)
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 2nd test: after 2-month intervention
Cognitive Tests: for everyday memory (3rd test)
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 3rd test: after 4-month intervention
Cognitive Tests: for everyday memory (4th test)
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Measured: 4th test: after 2-month follow up
Secondary outcomes (12)
Fitness Tests: BMI (pre-test)
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Measured: Pre-test (1st test): before intervention
Fitness Tests: BMI (2nd test)
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Measured: 2nd test: after 2-month intervention
Fitness Tests: BMI (3rd test)
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Measured: 3rd test: after 4-month intervention
Fitness Tests: BMI (4th test)
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Measured: 4th test: after 2-month follow up
Fitness Tests: Senior physical fitness test battery (pre-test)
Senior physical fitness test
Measured: Pre-test (1st test): before intervention
Fitness Tests: Senior physical fitness test battery (2nd test)
Senior physical fitness test
Measured: 2nd test: after 2-month intervention
Fitness Tests: Senior physical fitness test battery (3rd test)
Senior physical fitness test
Measured: 3rd test: after 4-month intervention
Fitness Tests: Senior physical fitness test battery (4th test)
Senior physical fitness test
Measured: 4th test: after 2-month follow up
Four square step test for dynamic balance (pre-test)
Four square step test
Measured: Pre-test (1st test): before intervention
Four square step test for dynamic balance (2nd test)
Four square step test
Measured: 2nd test: after 2-month intervention
Four square step test for dynamic balance (3rd test)
Four square step test
Measured: 3rd test: after 4-month intervention
Four square step test for dynamic balance (4th test)
Four square step test
Measured: 4th test: after 2-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Factorial
- Model description
- Cluster RCT. Each elderly center as a cluster will be randomly assigned to be either an intervention group (IG) to receive intervention training modes (A: cognitive training, B: physical training only, C: CCPT) or a control group (CG). IGs will either receive integrated format of ABC or two training modes of AB or BC or CA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Jacobs University Bremen gGmbH, The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Chow Bik-chu, Hong Kong Baptist University
- Investigators
- Bik-Chu CHOW, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727450
- Sponsor's protocol ID
- 12607620
- Acronym
- MTCCP
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our application of university human ethics, we have declared non-disclosure of individual data.
Publications
Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137
Chow BC, Jiao J, Man D, Lippke S. Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'. BMC Geriatr. 2022 May 6;22(1):398. doi: 10.1186/s12877-022-03031-5.
PubMed 35524188
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Training of Combined Cognitive and Physical and Cognitive or Physical Training Only on Cognition and Physical Fitness of Older Adults: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04727450
- Acronym / sponsor ID
- MTCCP / 12607620
- Conditions
- Cognitive Decline, Cognitive Impairment, Mild
- Keywords
- Intervention programs, Older adults, Cognitive & Physical Training, Cluster RCT, Multimodal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Jacobs University Bremen gGmbH, The Hong Kong Polytechnic University
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 Jan 2021 (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.
The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. The purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training [CCPT], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in Hong Kong. The study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.
Detailed description
The study design is a cluster randomized controlled trial. Twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. A total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. Each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. Each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. Assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Cluster RCT. Each elderly center as a cluster will be randomly assigned to be either an intervention group (IG) to receive intervention training modes (A: cognitive training, B: physical training only, C: CCPT) or a control group (CG). IGs will either receive integrated format of ABC or two training modes of AB or BC or CA.
| Arm | Type | Receives |
|---|---|---|
| 1. Integrated format | Active comparator | Behavioral: Cognitive training, Behavioral: physical training, Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAPIntegrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT). |
| 2. Cognitive training + Physical Training (A+B) | Active comparator | Behavioral: Cognitive training, Behavioral: physical trainingIntervention of A \& B treatments. |
| 3. Physical training + CCPT (B+C) | Active comparator | Behavioral: physical training, Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAPIntervention of B \& C treatments. |
| 4. CCPT + Cognitive training (C+A) | Active comparator | Behavioral: Cognitive training, Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAPIntervention of C \& A treatments. |
| 5. Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60 or above
- Both gender
- Willingness and capability to participate in this study and training
- Willingness and capability to give informed consent to participate in this study
- Pass the cutting-point of referenced screening tests (cognitive and emotional)
Key exclusion criteria (4 listed)
- A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease
- Early stages of Alzheimer's Disease, or the use of psychoactive drugs
- Complicated conditions that preclude regular attendance of the training
- Currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer ).
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 |
|---|---|---|
| Cognitive trainingInvolves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people. | Behavioural | 1. Integrated format, 2. Cognitive training + Physical Training (A+B), 4. CCPT + Cognitive training (C+A) |
| physical trainingInvolves learning of preselected routines of "line dancing" taught by a line dance instructor. | Behavioural | 1. Integrated format, 2. Cognitive training + Physical Training (A+B), 3. Physical training + CCPT (B+C) |
| Combination of cognitive and physical training (CCPT)-BIGMAPAlso: "Brain Invigoration Gross Motor Activation Program" (BIGMAP)BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu \& Chow, 2019). | Behavioural | 1. Integrated format, 3. Physical training + CCPT (B+C), 4. CCPT + Cognitive training (C+A) |
Primary outcome
Cognitive Tests: for executive function (pre-test)
Time frame: Pre-test (1st test): before intervention
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for executive function (2nd test)
Time frame: 2nd test: after 2-month intervention
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for executive function (3rd test)
Time frame: 3rd test: after 4-month intervention
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for executive function (4th test)
Time frame: 4th test: after 2-month follow up
Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for attention (pre-test)
Time frame: Pre-test (1st test): before intervention
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for attention (2nd test)
Time frame: 2nd test: after 2-month intervention
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for attention (3rd test)
Time frame: 3rd test: after 4-month intervention
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for attention (4th test)
Time frame: 4th test: after 2-month follow up
Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for everyday memory (pre-test)
Time frame: Pre-test (1st test): before intervention
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for everyday memory (2nd test)
Time frame: 2nd test: after 2-month intervention
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for everyday memory (3rd test)
Time frame: 3rd test: after 4-month intervention
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
Cognitive Tests: for everyday memory (4th test)
Time frame: 4th test: after 2-month follow up
Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.
12 secondary outcomes
Fitness Tests: BMI (pre-test)
Time frame: Pre-test (1st test): before intervention
Fitness Tests: BMI (2nd test)
Time frame: 2nd test: after 2-month intervention
Fitness Tests: BMI (3rd test)
Time frame: 3rd test: after 4-month intervention
Fitness Tests: BMI (4th test)
Time frame: 4th test: after 2-month follow up
Fitness Tests: Senior physical fitness test battery (pre-test)
Time frame: Pre-test (1st test): before intervention
Fitness Tests: Senior physical fitness test battery (2nd test)
Time frame: 2nd test: after 2-month intervention
Fitness Tests: Senior physical fitness test battery (3rd test)
Time frame: 3rd test: after 4-month intervention
Fitness Tests: Senior physical fitness test battery (4th test)
Time frame: 4th test: after 2-month follow up
Four square step test for dynamic balance (pre-test)
Time frame: Pre-test (1st test): before intervention
Four square step test for dynamic balance (2nd test)
Time frame: 2nd test: after 2-month intervention
Four square step test for dynamic balance (3rd test)
Time frame: 3rd test: after 4-month intervention
Four square step test for dynamic balance (4th test)
Time frame: 4th test: after 2-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- BackgroundFu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137
- Derived from this study: PubMed 35524188Chow BC, Jiao J, Man D, Lippke S. Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'. BMC Geriatr. 2022 May 6;22(1):398. doi: 10.1186/s12877-022-03031-5.
- Individual participant dataSharing planned: No. In our application of university human ethics, we have declared non-disclosure of individual data.
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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.
Bik-Chu CHOW, PhD principal investigator
Hong Kong Baptist 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 Cognitive training, physical training and Combination of cognitive and physical training (CCPT)-BIGMAP in people with Cognitive Decline and Cognitive Impairment, Mild, run by Hong Kong Baptist 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 8 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 Jan 2021. 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. 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 Bik-Chu CHOW, PhD (+85234117007, bchow@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Tests: for executive function (pre-test) (time frame: Pre-test (1st test): before intervention). The study lists 12 primary outcomes in all. 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 NCT04727450, which also lists 2 linked publications.
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 Jan 2021.