Mild Cognitive ImpairmentNCT04515563
Effectiveness of Walking Exercise in Improving Cognitive Function in Older Adults With Mild Cognitive Impairment
A study testing Stretching exercise, Low-frequency, moderate-intensity walking group and High-frequency, moderate-intensity walking group in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The increasing prevalence of mild cognitive impairment (MCI) in our rapidly aging population prompts the need for devising effective interventions to prevent the onset of cognitive impairment and delay its progression to dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Stretching exercise, Low-frequency, moderate-intensity walking group and High-frequency, moderate-intensity walking group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2020to 1 Sep 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults aged ≥ 50 years old;
- Ethnic Chinese;
- Diagnosed with mild cognitive impairment (MCI) under the Mayo Clinic criteria [8-10]: 1). Subjective complaint about a decline in cognitive function; 2). Total score in the Hong Kong version of the Montreal Cognitive Assessment is below the 7th percentile of the age- and education-corrected normative data of Hong Kong; 3). The decline in cognitive function does not impair daily functioning, as revealed by getting ≥ 2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living Scale (4-point Scale).
Who cannot join
- Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;
- Incapable of participating in physical exercise with major confounding conditions that are known to affect mobility. Specifically designed questionnaires will be used to screen for exclusion criteria including 1). Cannot walk without assistive device; 2). Any serious somatic condition that prevents walking exercise participation.
- History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and renal diseases;
- Diagnosis of psychiatric diseases, or currently using psychiatric medication.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Li Kai Shing Faculty of Medicine
Hong Kong, Southern District
About this study
Official title: Effectiveness of Different Exercise Intensities and Frequencies of Walking Exercise on Improving Cognitive Function in Older Adults With Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
The increasing prevalence of mild cognitive impairment (MCI) in our rapidly aging population prompts the need for devising effective interventions to prevent the onset of cognitive impairment and delay its progression to dementia. The benefits of aerobic exercise on the cognitive function in older adults with MCI are well-documented. However, exercise protocols and outcome measurement tools in the current literature are highly heterogeneous. It is therefore imperative to develop standard exercise prescription protocol for the MCI population or to examine the effectiveness of the existing, well-established exercise guidelines. The World Health Organization (WHO) recommends adults (18 - 64 years of age) and older adults (65 years and older) to perform 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week to improve cardiorespiratory and muscular fitness, bone health, and reduce the risk of non-communicable diseases and depression. Nonetheless, few studies have determined the effectiveness of the WHO Global Recommendations on Physical Activity for Health guideline in improving cognitive function in older adults with MCI. This study thus aims to evaluate the effectiveness of the WHO Physical Activity Recommendations in improving cognitive function in older adults with MCI. In 2017, the American Academy of Neurology (AAN) updated the Practice Guideline for Mild Cognitive Impairment, in which they recommended patients diagnosed with MCI to perform exercise at least twice a week for at least 6 months to gain cognitive benefits. This recommendation was based on two class-II studies, in which a 6-month twice-a-week 90-minute multicomponent exercise program helped maintain global cognition, and selective attention improved significantly following a 6-month twice-a-week 60-minute multicomponent exercise program. While they provided pivotal insights into clinical practice, there were several limitations for these two studies. For instance, in the study conducted by Nagamatsu et al., only female subjects were recruited, and therefore lead to low generalizability. These two studies focused on multi-component exercise intervention which included resistance training, aerobic training, and balance training, and the duration of each component was short (around 20 - 30 minutes). Studies that focus on single exercise modality with longer session duration are warranted to unveil the efficacy of a certain exercise modality in improving cognitive function. In this study, we will evaluate the effectiveness of aerobic exercise on improving cognitive function in older adults with MCI. We intend to follow the WHO Recommendations, focusing on evaluating the effect of different exercise intensities (moderate versus vigorous) and frequencies (once versus thrice per week) of aerobic exercise on improving the cognitive function in older adults with mild cognitive impairment. In particular, the AAN also suggested that physical activity of at least twice a week is necessary to produce cognitive benefits. We, therefore, aim to investigate whether one session per week would also suffice to improve the cognitive function in older adults with MCI.
Aims: To examine the effectiveness of 12-week WHO Global Recommendations on Physical Activity for Health in practice in improving the cognitive function in older adults with MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Stretching exercise, Low-frequency, moderate-intensity walking group, High-frequency, moderate-intensity walking group, Low-frequency, vigorous-intensity walking group, High-frequency, vigorous-intensity walking group
- Keywords
- Aerobic exercise, Walking exercise, 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.
Stretching exerciseBehavioural
Control Group
Low-frequency, moderate-intensity walking groupBehavioural
once-a-week walking exercise at moderate intensity
High-frequency, moderate-intensity walking groupBehavioural
thrice-a-week walking exercise at moderate intensity
Low-frequency, vigorous-intensity walking groupBehavioural
once-a-week walking exercise at vigorous intensity
High-frequency, vigorous-intensity walking groupBehavioural
thrice-a-week walking exercise at vigorous intensity
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Subjects in the care control group will perform once-a-week stretching exercise intervention. Each session lasts for 75 minutes and covers the major muscle groups. Receives: Behavioral: Stretching exercise |
| Low-frequency, moderate-intensity walking group | Experimental | A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with one 150-minute instructor-led session per week. In each session, there will be 5-min warm-up and cool-down, and 150 minutes of exercise time. If needed, there will be two 10-20 min breaks for the subject to get hydrated and rest. The intensity level will be set to 3.5 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. Receives: Behavioral: Low-frequency, moderate-intensity walking group |
| High-frequency, moderate-intensity walking group | Experimental | Intervention of high-frequency, moderate-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with three 50-minute instructor-led sessions per week. In each session, there will be 5-min warm-up and cool-down, and 50 minutes of exercise time. If needed, there will be one 10-20 min break for the subject to get hydrated and rest. The intensity level will be set to 3.5 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. Receives: Behavioral: High-frequency, moderate-intensity walking group |
| Low-frequency, vigorous-intensity walking group | Experimental | Intervention of low-frequency, vigorous-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with one 75-minute instructor-led session per week. In each session, there will be 5-min warm-up and cool-down, and 75 minutes of exercise time. If needed, there will be two 10-20 min breaks for the subject to get hydrated and rest. The intensity level will be set to 7.0 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. Receives: Behavioral: Low-frequency, vigorous-intensity walking group |
| High-frequency, vigorous-intensity walking group | Experimental | Intervention of high-frequency, vigorous-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with three 25-minute instructor-led sessions per week. In each session, there will be 5-min warm-up and cool-down, and 25 minutes of exercise time. If needed, there will be a 10-20 min break for the subject to get hydrated and rest. The intensity level will be set to 7.0 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. Receives: Behavioral: High-frequency, vigorous-intensity walking group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition-Hong Kong Montreal Cognitive Assessment (HK-MoCA) score
Age- and education-corrected Hong Kong Montreal Cognitive Assessment (HK-MoCA). The HK-MoCA is a validated assessment for cognitive screening that takes into account different domains of cognition, which will enable the researchers to achieve a better understanding of the global cognitive profile of the individual. Higher score indicates better global cognitive performance.
Measured: 3-month follow-up
Secondary outcomes (19)
Objective cognitive score
The NIH Toolbox Cognitive Function Battery (CFB) will be used to evaluate the various cognitive domains [15]. CFB will be delivered on a tablet computer. A total objective cognitive score will be generated, while a higher score indicates better cognitive performance.
Measured: 3-month follow-up
Working memory-Digit Span test
Working memory will be measured by Digit Span test in paper-pencil based manner. Higher score indicates better cognitive performance.
Measured: 3-month follow-up
Working memory-Verbal Fluency Test
Verbal Fluency Test will be used to measure working memory. Higher score indicates better cognitive performance.
Measured: 3-month follow-up
Executive function-Stroop test
Executive function will be measured by Stroop test. Shorter completion time indicates better performance.
Measured: 3-month follow-up
Executive function-Trail Making test
Executive function will be measured by Trail Making test. Shorter completion time indicates better performance.
Measured: 3-month follow-up
Subjective cognitive report
Cognitive self-report questionnaire (CSQR) will be used to test the subjective cognitive performance. CSQR is validated in HK and consists of 20 questions with overall score ranging from 0-100. Higher score indicates worse self-perception on cognitive performance.
Measured: 3-month follow-up
Remission rate-Chinese Abbreviated Mild Cognitive Impairment Test (CAMCI)
Chinese Abbreviated Mild Cognitive Impairment Test (CAMCI) will be used to classify participants into MCI and non-MCI category. The remission rate will be calculated as remission rate = number of participants in non-MCI category / number of total participants.
Measured: 3-month follow-up
Remission rate-Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Age- and education-corrected Hong Kong Montreal Cognitive Assessment (HK-MoCA). The HK-MoCA is a validated assessment for cognitive screening that takes into account different domains of cognition, which will enable the researchers to achieve a better understanding of the cognitive profile of the individual. MoCA will be used to classify participants into MCI and non-MCI category. The remission rate will be calculated as remission rate = number of participants in non-MCI category / number of total participants.
Measured: 3-month follow-up
VO2max
A VO2max test will be conducted using a calibrated motor-driven treadmill by continuous metabolic VO2 measurement using a COSMED Quark Series telemetric gas analysis system. The test will be performed using a modified bruce protocol. VO2, Borg's rating of perceived exertion (RPE) and heart rate (HR) will be continuously recorded. The maximal attainable heart rate will be recorded as the peak heart rate (HRpeak).
Measured: 3-month follow-up
Body fat mass
Body fat mass of participants will be measured by dual-energy X-ray absorptiometry (DXA).
Measured: 3-month follow-up
Lean mass
Lean mass of participants will be measured by dual-energy X-ray absorptiometry (DXA).
Measured: 3-month follow-up
Bone mineral density
Bone mineral density of participants will be measured by dual-energy X-ray absorptiometry (DXA).
Measured: 3-month follow-up
Habitual sleep
The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument to estimate sleep quantity and quality. The PSQI has been commonly used to distinguish people with primary insomnia from normal sleepers. The Chinese version of PSQI has been validated to have a satisfactory Cronbach's alpha of 0.82-0.83 and test-retest reliability of 0.85 among Hong Kong Chinese older adults. The overall score ranges from 0 to 24 while a higher score indicates worse sleep quality.
Measured: 3-month follow-up
Quality of Life-12-item Short Form Survey (SF-12)
The 12-item Short Form Survey (SF-12) will be used to assess the quality of life of the participant and higher scores (physical and mental sub-scale) indicate better quality of life.
Measured: 3-month follow-up
Depression level
Patient Health Questionnaire-9 (PHQ-9) will also be used to assess the mental health of the subjects. A PHQ-9 score of ≥ 10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 correspond to mild, moderate, moderately severe, and severe depression, respectively. Results are similar in the primary care and obstetrics-gynecology samples. The PHQ-9 is a reliable and valid measure of depression severity and its brevity make the PHQ-9 a useful clinical and research tool.
Measured: 3-month follow-up
Mental health
Hospital Anxiety and Depression Scale (HADS) will used to measure the mental health of participants. It is a 7-item questionnaire having an overall score that ranges from 0 to 21 (with sub-scales for both anxiety and depression), with a higher score indicating more severe symptoms.
Measured: 3-month follow-up
Anxiety level
Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to measure the anxiety level of participants. It is a 7-item questionnaire having an overall score that ranges from 0 to 21 with a higher score indicating more severe symptoms.
Measured: 3-month follow-up
Physical activity
The International Physical Activity Questionnaire (IPAQ) will be used to assess the activity level of the subjects.
Measured: 3-month follow-up
Balance performance
The balance ability of the subjects will be measured by single leg standing test. The longer standing duration indicates better balance performance.
Measured: 3-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 posted17 Aug 2020
- Study start1 Mar 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
- Investigators
- MING FAI SIU, Ph.D., Study director, School of Public Health, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515563
- Sponsor's protocol ID
- RF-3030059835-007
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.
Publications
Yu DJ, Yu AP, Bernal JDK, Fong DY, Chan DKC, Cheng CP, Siu PM. Effects of exercise intensity and frequency on improving cognitive performance in middle-aged and older adults with mild cognitive impairment: A pilot randomized controlled trial on the minimum physical activity recommendation from WHO. Front Physiol. 2022 Sep 19;13:1021428. doi: 10.3389/fphys.2022.1021428. eCollection 2022.
PubMed 36200056
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Exercise Intensities and Frequencies of Walking Exercise on Improving Cognitive Function in Older Adults With Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04515563
- Acronym / sponsor ID
- RF-3030059835-007
- Conditions
- Mild Cognitive Impairment
- Keywords
- Aerobic exercise, Walking exercise, Mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Aug 2020 (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 increasing prevalence of mild cognitive impairment (MCI) in our rapidly aging population prompts the need for devising effective interventions to prevent the onset of cognitive impairment and delay its progression to dementia. The benefits of aerobic exercise on the cognitive function in older adults with MCI are well-documented. However, exercise protocols and outcome measurement tools in the current literature are highly heterogeneous. It is therefore imperative to develop standard exercise prescription protocol for the MCI population or to examine the effectiveness of the existing, well-established exercise guidelines. The World Health Organization (WHO) recommends adults (18 - 64 years of age) and older adults (65 years and older) to perform 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week to improve cardiorespiratory and muscular fitness, bone health, and reduce the risk of non-communicable diseases and depression. Nonetheless, few studies have determined the effectiveness of the WHO Global Recommendations on Physical Activity for Health guideline in improving cognitive function in older adults with MCI. This study thus aims to evaluate the effectiveness of the WHO Physical Activity Recommendations in improving cognitive function in older adults with MCI. In 2017, the American Academy of Neurology (AAN) updated the Practice Guideline for Mild Cognitive Impairment, in which they recommended patients diagnosed with MCI to perform exercise at least twice a week for at least 6 months to gain cognitive benefits. This recommendation was based on two class-II studies, in which a 6-month twice-a-week 90-minute multicomponent exercise program helped maintain global cognition, and selective attention improved significantly following a 6-month twice-a-week 60-minute multicomponent exercise program. While they provided pivotal insights into clinical practice, there were several limitations for these two studies. For instance, in the study conducted by Nagamatsu et al., only female subjects were recruited, and therefore lead to low generalizability. These two studies focused on multi-component exercise intervention which included resistance training, aerobic training, and balance training, and the duration of each component was short (around 20 - 30 minutes). Studies that focus on single exercise modality with longer session duration are warranted to unveil the efficacy of a certain exercise modality in improving cognitive function. In this study, we will evaluate the effectiveness of aerobic exercise on improving cognitive function in older adults with MCI. We intend to follow the WHO Recommendations, focusing on evaluating the effect of different exercise intensities (moderate versus vigorous) and frequencies (once versus thrice per week) of aerobic exercise on improving the cognitive function in older adults with mild cognitive impairment. In particular, the AAN also suggested that physical activity of at least twice a week is necessary to produce cognitive benefits. We, therefore, aim to investigate whether one session per week would also suffice to improve the cognitive function in older adults with MCI.
Aims: To examine the effectiveness of 12-week WHO Global Recommendations on Physical Activity for Health in practice in improving the cognitive function in older adults with MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Stretching exerciseSubjects in the care control group will perform once-a-week stretching exercise intervention. Each session lasts for 75 minutes and covers the major muscle groups. |
| Low-frequency, moderate-intensity walking group | Experimental | Behavioral: Low-frequency, moderate-intensity walking groupA personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with one 150-minute instructor-led session per week. In each session, there will be 5-min warm-up and cool-down, and 150 minutes of exercise time. If needed, there will be two 10-20 min breaks for the subject to get hydrated and rest. The intensity level will be set to 3.5 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. |
| High-frequency, moderate-intensity walking group | Experimental | Behavioral: High-frequency, moderate-intensity walking groupIntervention of high-frequency, moderate-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with three 50-minute instructor-led sessions per week. In each session, there will be 5-min warm-up and cool-down, and 50 minutes of exercise time. If needed, there will be one 10-20 min break for the subject to get hydrated and rest. The intensity level will be set to 3.5 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. |
| Low-frequency, vigorous-intensity walking group | Experimental | Behavioral: Low-frequency, vigorous-intensity walking groupIntervention of low-frequency, vigorous-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with one 75-minute instructor-led session per week. In each session, there will be 5-min warm-up and cool-down, and 75 minutes of exercise time. If needed, there will be two 10-20 min breaks for the subject to get hydrated and rest. The intensity level will be set to 7.0 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. |
| High-frequency, vigorous-intensity walking group | Experimental | Behavioral: High-frequency, vigorous-intensity walking groupIntervention of high-frequency, vigorous-intensity walking exercise will be given to subjects in this group. A personalized walking exercise program will be arranged and conducted individually. Exercise training will be prescribed as a 12-week program, with three 25-minute instructor-led sessions per week. In each session, there will be 5-min warm-up and cool-down, and 25 minutes of exercise time. If needed, there will be a 10-20 min break for the subject to get hydrated and rest. The intensity level will be set to 7.0 metabolic equivalents (METs), in which 1 MET refers to the metabolic rate during quiet sitting [23]. During the training session, the heart rate will be continuously monitored by Polar E68 HR Sensor to make sure the subject meet the exercise intensity. 10 bpm fluctuation of the heart rate is acceptable [24]. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older adults aged ≥ 50 years old;
- Ethnic Chinese;
- Diagnosed with mild cognitive impairment (MCI) under the Mayo Clinic criteria [8-10]: 1). Subjective complaint about a decline in cognitive function; 2). Total score in the Hong Kong version of the Montreal Cognitive Assessment is below the 7th percentile of the age- and education-corrected normative data of Hong Kong; 3). The decline in cognitive function does not impair daily functioning, as revealed by getting ≥ 2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living Scale (4-point Scale).
Key exclusion criteria (4 listed)
- Diagnosis of dementia/Alzheimer's disease, or currently using antidementia medication;
- Incapable of participating in physical exercise with major confounding conditions that are known to affect mobility. Specifically designed questionnaires will be used to screen for exclusion criteria including 1). Cannot walk without assistive device; 2). Any serious somatic condition that prevents walking exercise participation.
- History of major diseases e.g. cancer, cardio-/cerebrovascular, neurodegenerative and renal diseases;
- Diagnosis of psychiatric diseases, or currently using psychiatric medication.
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 |
|---|---|---|
| Stretching exerciseControl Group | Behavioural | Control Group |
| Low-frequency, moderate-intensity walking grouponce-a-week walking exercise at moderate intensity | Behavioural | Low-frequency, moderate-intensity walking group |
| High-frequency, moderate-intensity walking groupthrice-a-week walking exercise at moderate intensity | Behavioural | High-frequency, moderate-intensity walking group |
| Low-frequency, vigorous-intensity walking grouponce-a-week walking exercise at vigorous intensity | Behavioural | Low-frequency, vigorous-intensity walking group |
| High-frequency, vigorous-intensity walking groupthrice-a-week walking exercise at vigorous intensity | Behavioural | High-frequency, vigorous-intensity walking group |
Primary outcome
Global cognition-Hong Kong Montreal Cognitive Assessment (HK-MoCA) score
Time frame: 3-month follow-up
Age- and education-corrected Hong Kong Montreal Cognitive Assessment (HK-MoCA). The HK-MoCA is a validated assessment for cognitive screening that takes into account different domains of cognition, which will enable the researchers to achieve a better understanding of the global cognitive profile of the individual. Higher score indicates better global cognitive performance.
19 secondary outcomes
Objective cognitive score
Time frame: 3-month follow-up
Working memory-Digit Span test
Time frame: 3-month follow-up
Working memory-Verbal Fluency Test
Time frame: 3-month follow-up
Executive function-Stroop test
Time frame: 3-month follow-up
Executive function-Trail Making test
Time frame: 3-month follow-up
Subjective cognitive report
Time frame: 3-month follow-up
Remission rate-Chinese Abbreviated Mild Cognitive Impairment Test (CAMCI)
Time frame: 3-month follow-up
Remission rate-Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Time frame: 3-month follow-up
VO2max
Time frame: 3-month follow-up
Body fat mass
Time frame: 3-month follow-up
Lean mass
Time frame: 3-month follow-up
Bone mineral density
Time frame: 3-month follow-up
Habitual sleep
Time frame: 3-month follow-up
Quality of Life-12-item Short Form Survey (SF-12)
Time frame: 3-month follow-up
Depression level
Time frame: 3-month follow-up
Mental health
Time frame: 3-month follow-up
Anxiety level
Time frame: 3-month follow-up
Physical activity
Time frame: 3-month follow-up
Balance performance
Time frame: 3-month follow-up
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 11 Nov 2021.
- Derived from this study: PubMed 36200056Yu DJ, Yu AP, Bernal JDK, Fong DY, Chan DKC, Cheng CP, Siu PM. Effects of exercise intensity and frequency on improving cognitive performance in middle-aged and older adults with mild cognitive impairment: A pilot randomized controlled trial on the minimum physical activity recommendation from WHO. Front Physiol. 2022 Sep 19;13:1021428. doi: 10.3389/fphys.2022.1021428. eCollection 2022.
- Individual participant dataSharing planned: Yes. The data of individual participants that underlie the results reported in this trial, after de-identification including text, tables, figures, and appendices, as well as study protocol and statistical analysis plan, will be shared after 3 months of study publication. Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for the data requests, a data-access agreement needs to be signed.
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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.
MING FAI SIU, Ph.D. study director
School of Public Health, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching exercise, Low-frequency, moderate-intensity walking group and High-frequency, moderate-intensity walking group in people with Mild Cognitive Impairment, run by The University of Hong Kong 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: finished, as of the sponsor's last update on 11 Nov 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. 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?
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?
Global cognition-Hong Kong Montreal Cognitive Assessment (HK-MoCA) score (time frame: 3-month follow-up). 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 NCT04515563, 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 11 Nov 2021.