MCINCT05764421
Motor-cognitive Interventions Are Effective in Improving Cognitive Function in Older Adults With Mild Cognitive impairment--a Chinese Sample
A study testing motor-cognitive intervention in people with MCI, run by Jinxuan Cheng at 1 site in China.
Trial summary
Mild cognitive impairment (MCI) is a syndrome that occurs in the preclinical stage of Alzheimer, and early intervention can be effective in preventing Alzheimer, but further research is needed on intervention methods. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- MCI
- What is being tested?
- motor-cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Feb 2021
- 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
- Age ≥65 years old;
- The screening results were mild cognitive impairment;
- Those who have the ability to walk independently or use auxiliary tools and can ·Communicate with each other normally;
- Informed consent, willing to participate in the researcher.
Who cannot join
- People with mental disorders;
- Patients with serious organ diseases, such as kidney and heart failure;
- People with mobility disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Mild cognitive impairment (MCI) is a syndrome that occurs in the preclinical stage of Alzheimer, and early intervention can be effective in preventing Alzheimer, but further research is needed on intervention methods. In order to identify interventions that are more suitable for Chinese characteristics and to investigate the effects of a motor-cognitive intervention on the cognitive function of older adults with MCI, investigators screened 103 community-dwelling older adults with MCI aged 65 years and older in Qingdao, Shandong, China, and divided them into an intervention group and a control group, and administered a motor-cognitive intervention to the intervention group for 12 weeks. Investigators assessed the cognitive abilities of MCI participants using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). There were no demographic differences between the intervention and control groups. Investigators found that the cognitive abilities of the intervention group were significantly improved at the end of the intervention as well as at the end of the follow-up compared to the control group. The results of the current study suggest that the motor-cognitive intervention investigators used significantly improved cognitive function in older adults with MCI and was easy for older adults to master, and that it was a good intervention for cognitive function in older adults with MCI in the Chinese community.
- Conditions
- MCI
- Being tested
- motor-cognitive intervention
- Keywords
- motor-cognitive intervention, older adults, cognitive ability, 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.
motor-cognitive interventionBehavioural
The intervention included physical activity and integrated cognitive training. The training was conducted in three sessions. The first session was a warm-up and wake-up preparation, in which participants massaged facial acupoints in a seated position to light music. In the middle phase of aerobic exercise, participants raised their legs in a standing position and performed mental exercises to fast-paced music. Session 1: tapping the five fingers of each hand in turn; Section 2: The thumb of both hands in turn to tap the rest of the fingers; Third section: hands five fingers cross fist; Section 4: The five fingers of both hands are stretched out in turn, and then retracted in turn. The final session was a relaxation session in which participants performed inspiratory and expiratory exercises to light music. The integrated cognitive training consisted of 15 minutes of attention training, 15 minutes of memory training, and 15 minutes of executive function training.
| Study group | Role | What they receive |
|---|---|---|
| intervention groups | Experimental | The experimental group received a uniform exercise - cognitive intervention at a community health centre or a geriatric activity station. The intervention lasted for a total of 12 weeks at a frequency of once every fortnight, with each intervention lasting 60-90 minutes. At the end of the intervention, the participants were followed up by the researchers for a total of 12 weeks, at a frequency of once every fortnight.
The intervention consisted of physical-motor activities as well as integrated cognitive training. Receives: Behavioral: motor-cognitive intervention |
| control group | No intervention | Participants in the control group did not undergo any intervention and kept their old lifestyle unchanged. The control group was asked to avoid cognitive training and exercise training beyond the routine throughout the investigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized estimating equations for the two groups of MMSE scores at three time points
The Shapiro-Wilk test was used to assess the normality of the data and found that the MMSE scores of the two groups of MCI participants were not normally distributed at all three time points, so we used medians and quartiles to describe the data. Generalized estimating equations were used to analyze the trends in MMSE scores at each time point for both groups. As seen in Table 4, the MMSE scores in the intervention group showed an increasing trend over time compared to the control group. There was a significant time effect (χ² = 27.259, p < 0.001) and a significant group effect (χ² = 21.267, p < 0.001) for the MMSE scores of the two groups. This indicates that the intervention used in this study was effective in improving the cognitive level of MCI patients in the intervention group. In order to visualize the trend in MMSE scores, a line graph was used to represent the change.
Measured: 2020.8-2021.2
Between-group comparison of the MMSE scores of the two study groups at different time points
At different time points, the MMSE scores of the two study groups were not normally distributed, therefore, the between-group differences in the MMSE scores of the two study groups at the three time points were statistically analyzed using a two independent samples non-parametric rank sum test. The results showed a significant difference in MMSE scores between the two groups of participants at the end of the intervention (Z = 5.406, p < 0.001). At the end of follow-up, there was a significant difference in MMSE scores between the two groups of participants (Z = 5.403, p < 0.001).
Measured: 2020.8-2021.2
Intra-group comparison of MMSE scores between the two groups
As the MMSE scores of MCI older adults in both the intervention and control groups were not normally distributed at all three time points, a paired rank sum test was used to compare the change in MMSE scores between the two groups of participants before and after the intervention. The results showed that MMSE scores in the intervention group were significantly higher at the end of the intervention compared to the initial level (Z = -4.287, p < 0.001). MMSE scores in the intervention group were significantly higher at the end of follow-up compared to initial levels (Z = -4.251, p < 0.001).
Measured: 2020.8-2021.2
Generalized estimating equations for MoCA scores for two groups of older people at three time points
The MoCA scores of the two groups of MCI older adults were not normally distributed at all three time points, so generalised estimating equations were used to analyze the trends in the MoCA scores of the two groups at each time point. As seen in Table 7, there was a significant upward trend in MoCA scores over time in the intervention group compared to the control group. There was a significant time effect (χ² = 46.922, p < 0.001) and a significant group effect (χ² = 60.992, p < 0.001) for the MoCA scores of the participants in both groups. This indicates that the intervention method used in this study was effective in improving the cognitive level of MCI patients in the intervention group. To visualize the trend of MoCA scores, a line graph was used to represent the trend.
Measured: 2020.8-2021.2
Intergroup comparison of MoCA scores between the two study groups
The MoCA scores of the two study groups were not normally distributed at different time points, therefore, the between-group differences in the MoCA scores of the two study groups before the intervention, at the end of the intervention and at the end of follow-up were statistically analysed using a two independent samples non-parametric rank sum test. The results showed that the difference in MoCA scores between the two groups of participants at the end of the intervention was significant (Z = 6.108, p < 0.001). At the end of follow-up, there was a significant difference in MoCA scores between the two groups of participants (Z = 6.215, p < 0.001).
Measured: 2020.8-2021.2
Intra-group comparison of MoCA scores between the two groups of older people
As the MoCA scores of MCI older adults in both the intervention and control groups were not normally distributed at the three time points, a paired rank sum test was used to compare the change in MoCA scores of the two groups of older adults before and after the intervention. The results showed that MoCA scores in the intervention group were significantly higher at the end of the intervention compared to the initial level (Z = -5.539, p < 0.001). MoCA scores in the intervention group were significantly higher at the end of follow-up compared to initial levels (Z = -5.330, p < 0.001).
Measured: 2020.8-2021.2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Aug 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies 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
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinxuan Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinxuan Cheng, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764421
- Sponsor's protocol ID
- JCheng
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-cognitive Interventions Are Effective in Improving Cognitive Function in Older Adults With Mild Cognitive impairment--a Chinese Sample
- ClinicalTrials.gov ID
- NCT05764421
- Acronym / sponsor ID
- JCheng
- Conditions
- MCI
- Keywords
- motor-cognitive intervention, older adults, cognitive ability, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Jinxuan ChengUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 10 Mar 2023 (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.
Mild cognitive impairment (MCI) is a syndrome that occurs in the preclinical stage of Alzheimer, and early intervention can be effective in preventing Alzheimer, but further research is needed on intervention methods. In order to identify interventions that are more suitable for Chinese characteristics and to investigate the effects of a motor-cognitive intervention on the cognitive function of older adults with MCI, investigators screened 103 community-dwelling older adults with MCI aged 65 years and older in Qingdao, Shandong, China, and divided them into an intervention group and a control group, and administered a motor-cognitive intervention to the intervention group for 12 weeks. Investigators assessed the cognitive abilities of MCI participants using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). There were no demographic differences between the intervention and control groups. Investigators found that the cognitive abilities of the intervention group were significantly improved at the end of the intervention as well as at the end of the follow-up compared to the control group. The results of the current study suggest that the motor-cognitive intervention investigators used significantly improved cognitive function in older adults with MCI and was easy for older adults to master, and that it was a good intervention for cognitive function in older adults with MCI in the Chinese community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention groups | Experimental | Behavioral: motor-cognitive interventionThe experimental group received a uniform exercise - cognitive intervention at a community health centre or a geriatric activity station. The intervention lasted for a total of 12 weeks at a frequency of once every fortnight, with each intervention lasting 60-90 minutes. At the end of the intervention, the participants were followed up by the researchers for a total of 12 weeks, at a frequency of once every fortnight. The intervention consisted of physical-motor activities as well as integrated cognitive training. |
| control group | No intervention | –Participants in the control group did not undergo any intervention and kept their old lifestyle unchanged. The control group was asked to avoid cognitive training and exercise training beyond the routine throughout the investigation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years old;
- The screening results were mild cognitive impairment;
- Those who have the ability to walk independently or use auxiliary tools and can ·Communicate with each other normally;
- Informed consent, willing to participate in the researcher.
Key exclusion criteria (3 listed)
- People with mental disorders;
- Patients with serious organ diseases, such as kidney and heart failure;
- People with mobility disabilities.
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 |
|---|---|---|
| motor-cognitive interventionThe intervention included physical activity and integrated cognitive training. The training was conducted in three sessions. The first session was a warm-up and wake-up preparation, in which participants massaged facial acupoints in a seated position to light music. In the middle phase of aerobic exercise, participants raised their legs in a standing position and performed mental exercises to fast-paced music. Session 1: tapping the five fingers of each hand in turn; Section 2: The thumb of both hands in turn to tap the rest of the fingers; Third section: hands five fingers cross fist; Section 4: The five fingers of both hands are stretched out in turn, and then retracted in turn. The final session was a relaxation session in which participants performed inspiratory and expiratory exercises to light music. The integrated cognitive training consisted of 15 minutes of attention training, 15 minutes of memory training, and 15 minutes of executive function training. | Behavioural | intervention groups |
Primary outcome
Generalized estimating equations for the two groups of MMSE scores at three time points
Time frame: 2020.8-2021.2
The Shapiro-Wilk test was used to assess the normality of the data and found that the MMSE scores of the two groups of MCI participants were not normally distributed at all three time points, so we used medians and quartiles to describe the data. Generalized estimating equations were used to analyze the trends in MMSE scores at each time point for both groups. As seen in Table 4, the MMSE scores in the intervention group showed an increasing trend over time compared to the control group. There was a significant time effect (χ² = 27.259, p < 0.001) and a significant group effect (χ² = 21.267, p < 0.001) for the MMSE scores of the two groups. This indicates that the intervention used in this study was effective in improving the cognitive level of MCI patients in the intervention group. In order to visualize the trend in MMSE scores, a line graph was used to represent the change.
Between-group comparison of the MMSE scores of the two study groups at different time points
Time frame: 2020.8-2021.2
At different time points, the MMSE scores of the two study groups were not normally distributed, therefore, the between-group differences in the MMSE scores of the two study groups at the three time points were statistically analyzed using a two independent samples non-parametric rank sum test. The results showed a significant difference in MMSE scores between the two groups of participants at the end of the intervention (Z = 5.406, p < 0.001). At the end of follow-up, there was a significant difference in MMSE scores between the two groups of participants (Z = 5.403, p < 0.001).
Intra-group comparison of MMSE scores between the two groups
Time frame: 2020.8-2021.2
As the MMSE scores of MCI older adults in both the intervention and control groups were not normally distributed at all three time points, a paired rank sum test was used to compare the change in MMSE scores between the two groups of participants before and after the intervention. The results showed that MMSE scores in the intervention group were significantly higher at the end of the intervention compared to the initial level (Z = -4.287, p < 0.001). MMSE scores in the intervention group were significantly higher at the end of follow-up compared to initial levels (Z = -4.251, p < 0.001).
Generalized estimating equations for MoCA scores for two groups of older people at three time points
Time frame: 2020.8-2021.2
The MoCA scores of the two groups of MCI older adults were not normally distributed at all three time points, so generalised estimating equations were used to analyze the trends in the MoCA scores of the two groups at each time point. As seen in Table 7, there was a significant upward trend in MoCA scores over time in the intervention group compared to the control group. There was a significant time effect (χ² = 46.922, p < 0.001) and a significant group effect (χ² = 60.992, p < 0.001) for the MoCA scores of the participants in both groups. This indicates that the intervention method used in this study was effective in improving the cognitive level of MCI patients in the intervention group. To visualize the trend of MoCA scores, a line graph was used to represent the trend.
Intergroup comparison of MoCA scores between the two study groups
Time frame: 2020.8-2021.2
The MoCA scores of the two study groups were not normally distributed at different time points, therefore, the between-group differences in the MoCA scores of the two study groups before the intervention, at the end of the intervention and at the end of follow-up were statistically analysed using a two independent samples non-parametric rank sum test. The results showed that the difference in MoCA scores between the two groups of participants at the end of the intervention was significant (Z = 6.108, p < 0.001). At the end of follow-up, there was a significant difference in MoCA scores between the two groups of participants (Z = 6.215, p < 0.001).
Intra-group comparison of MoCA scores between the two groups of older people
Time frame: 2020.8-2021.2
As the MoCA scores of MCI older adults in both the intervention and control groups were not normally distributed at the three time points, a paired rank sum test was used to compare the change in MoCA scores of the two groups of older adults before and after the intervention. The results showed that MoCA scores in the intervention group were significantly higher at the end of the intervention compared to the initial level (Z = -5.539, p < 0.001). MoCA scores in the intervention group were significantly higher at the end of follow-up compared to initial levels (Z = -5.330, p < 0.001).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor-cognitive intervention in people with MCI, run by Jinxuan Cheng at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 Mar 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Generalized estimating equations for the two groups of MMSE scores at three time points (time frame: 2020.8-2021.2). The study lists 6 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 10 Mar 2023.