Healthy AgeingNCT04641429
Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People
A study testing Qigong exercise and Stretching exercise in people with Healthy Ageing, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Qigong exercise and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2019to Oct 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least finished primary school;
- Have normal or corrected-to-normal vision and hearing;
- Ability to do exercise;
- Right-hand dominance;
- Normal cognitive ability as assessed by the Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
Who cannot join
- Abmormal anxiety or depression mood as measured by the Hospital Anxiety and Depression Scale;
- Current diagnosis or history of neurological or psychological conditions, such as substance abuse, psychotic disorders, or affective disorders;
- Current diagnosis or history of substance/alcohol abuse;
- Contraindications for MRI scanning (e.g. implanted metal);
- People who regularly practice any qigong, Tai Chi or similar exercise or meditation within 6 months before study;
- People who regularly practice moderate to high intensity physical exercise within 6 months before study. The operational definition of 'regular practice' is three times a week or more, at least 30 mins per time for at least 3 months.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Tatia Lee, PhD, 852-39178394, tmclee@hku.hk
Tatia Lee, PhD
About this study
This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways.
Read the detailed description
Population aging is accelerating. The socioeconomic burden associated with an aging population calls for timely action for promoting brain health. The human brain has the capacity for plastic reorganization through learning and experience. Physical activity could induce plasticity and is important in the prevention of functional decline and increased survival. In this study, the effects of Qigong and stretching exercise on affective and cognitive function among the healthy elderly are investigated. This study is proposed to invite 200 participants (100 in each intervention condition). The investigators acquire data from questionnaires, assessments, neurocognitive tests, magnetic resonance imaging and blood samples at baseline (before the intervention) and post-intervention.
- Conditions
- Healthy Ageing
- Being tested
- Qigong exercise, Stretching exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong exerciseBehavioural
Participants in the experimental group receive 12-week group-based Qigong exercise training.
Stretching exerciseBehavioural
Participants in the control group receive 12-week group-based stretching exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | Participants in the experimental group receive Qigong exercise training. Receives: Behavioral: Qigong exercise |
| stretching | Active comparator | Participants in the control group receive stretching exercise training. Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline in cognitive processing speed scores on the Symbol Digit Modalities Test at 12 Weeks
Changes of cognitive processing speed scores are measured by the Symbol Digit Modalities Test from baseline to end of intervention at 12 Weeks. Scores on the Symbol Digit Modalities Test range from 0-90, with a higher score indicating better performance.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in sustained attention scores on the Continuous Performance Test at 12 Weeks
Changes of sustained attention scores are measured by the Continuous Performance Test from baseline to end of intervention at 12 weeks. The accuracy scores on the Continuous Performance Test range from 0-100%, with a higher score indicating better performance.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in working memory scores on the Digit Span-Backward Test at 12 Weeks
Changes of working memory scores are measured by the Digit Span Backward Test from baseline to end of intervention at 12 weeks. Scores on the Digit Span-Backward test range from 2-13, with a higher score indicating better performance.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in language scores on the Rapid Naming Test at 12 Weeks
Changes of language scores are measured by the Rapid Naming Test from baseline to end of intervention at 12 weeks. Scores on the Rapid Naming Test range from 0-36, with a higher score indicating better performance.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in trait affect scores on the Chinese Affect Scale at 12 Weeks
Changes of trait positive affect and negative affect are measured by the Chinese Affect Scale from baseline to end of intervention at 12 weeks. Positive and negative affect scores on Chinese Affect Scale both range from 10-50, with a higher score indicating higher positive/negative affect.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in affective processing by the Emotion Processing Task at 12 weeks
Changes of affective stimuli processing are measured by the Emotion Processing Task from baseline to end of intervention at 12 weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in blood levels of cortisol at 12 Weeks
Changes of blood biomarker levels of cortisol are measured from baseline to end of intervention at 12 weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in blood levels of interleukin-6 at 12 Weeks
Changes of blood biomarker levels of interleukin-6 are measured from baseline to end of intervention at 12 weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in blood levels of brain-derived neurotrophic factor at 12 Weeks
Changes of blood biomarker levels of brain-derived neurotrophic factor are measured from baseline to end of intervention at 12 weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in telomerase activity at 12 Weeks
Changes of blood measurement of telomerase activity are measured from baseline to end of intervention at 12 weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in brain structure by magnetic resonance imaging at 12 Weeks
Changes of brain structure are measured by T1-weighted magnetic resonance imaging from baseline to end of intervention at 12 Weeks.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in brain function by functional magnetic resonance imaging at 12 Weeks
Changes of brain function are measured by functional magnetic resonance imaging from baseline to end of intervention at 12 Weeks.
Measured: from baseline to end of intervention at 12 weeks
Secondary outcomes (8)
Mean change from Baseline in perceived stress scores on the Perceived Stress Scale at 12 weeks
Changes of perceived stress scores are measured by the Perceived Stress Scale from baseline to end of intervention at 12 weeks. Scores on the Perceived Stress Scale range from 0-56, with a higher score indicating higher perceived stress.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in insomnia severity scores on the Insomnia Severity Index at 12 weeks
Changes of insomnia severity scores are measured by the Insomnia Severity Index from baseline to end of intervention at 12 weeks. Scores on the Insomnia Severity Index range from 0-28, with a higher score indicating more severe insomnia.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in quality of sleep on the Pittsburg Seep Quality Index at 12 weeks
Changes of quality of sleep scores are measured by the Pittsburg Seep Quality Index from baseline to end of intervention at 12 weeks. Scores on the Pittsburg Seep Quality Index range from 0-21, with a higher score indicating more severe sleeping difficulty.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in depression and anxiety scores on the Hospital Anxiety and Depression Scale at 12 weeks
Changes of depression and anxiety scores are measured by the Hospital Anxiety and Depression Scale from baseline to end of intervention at 12 weeks. Anxiety and Depression scores on the Hospital Anxiety and Depression Scale both range from 0-21, with a higher score indicating more severe anxiety/depression mood.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in perceived loneliness scores on the UCLA Loneliness Scale at 12 weeks
Changes of perceived loneliness scores are measured by the UCLA Loneliness Scale from baseline to end of intervention at 12 weeks. The scores on the UCLA Loneliness Scale range from 20-80, with a higher score indicating greater perceived loneliness.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in quality of life scores on the WHO Quality of Life-BREF scale at 12 weeks
Changes of quality of life scores are measured by the WHO Quality of Life-BREF scale from baseline to end of intervention at 12 weeks. The scores on the WHO Quality of Life-BREF scale range from 26-130, with a higher score indicating higher quality of life.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in emotion reactivity scores on the Emotion Reactivity Scale at 12 weeks
Changes of emotion reactivity scores are measured by the Emotion Reactivity Scale from baseline to end of intervention at 12 weeks. The scores on the Emotion Reactivity Scale range from 0-84, with a higher score indicating greater emotional reactivity.
Measured: from baseline to end of intervention at 12 weeks
Mean change from Baseline in somatization scores on the somatization subscale of Symptom Check-List-90 at 12 weeks
Changes of somatization scores are measured by the somatization subscale of Symptom Check-List-90 from baseline to end of intervention at 12 weeks. Scores on the somatization subscale of Symptom Check-List-90 range from 0-48, with a higher score indicating greater somatization.
Measured: from baseline to end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start2 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (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 Healthy AgeingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this intervention study, each participant is allocated to either the Qigong or stretching exercise training group in a pseudo-randomized order based on the recruitment orders and their availability.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Tatia Mei-chun LEE, The University of Hong Kong
- Investigators
- Tatia Lee, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641429
- Sponsor's protocol ID
- UW 19-005
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi D, Wong NML, Shao R, Man ISC, Wong CHY, Yuen LP, Chan CCH, Lee TMC. Qigong exercise enhances cognitive functions in the elderly via an interleukin-6-hippocampus pathway: A randomized active-controlled trial. Brain Behav Immun. 2021 Jul;95:381-390. doi: 10.1016/j.bbi.2021.04.011. Epub 2021 Apr 17.
PubMed 33872709
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People
- ClinicalTrials.gov ID
- NCT04641429
- Acronym / sponsor ID
- UW 19-005
- Conditions
- Healthy Ageing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 23 Nov 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.
This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways.
Detailed description
Population aging is accelerating. The socioeconomic burden associated with an aging population calls for timely action for promoting brain health. The human brain has the capacity for plastic reorganization through learning and experience. Physical activity could induce plasticity and is important in the prevention of functional decline and increased survival. In this study, the effects of Qigong and stretching exercise on affective and cognitive function among the healthy elderly are investigated. This study is proposed to invite 200 participants (100 in each intervention condition). The investigators acquire data from questionnaires, assessments, neurocognitive tests, magnetic resonance imaging and blood samples at baseline (before the intervention) and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this intervention study, each participant is allocated to either the Qigong or stretching exercise training group in a pseudo-randomized order based on the recruitment orders and their availability.
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: Qigong exerciseParticipants in the experimental group receive Qigong exercise training. |
| stretching | Active comparator | Behavioral: Stretching exerciseParticipants in the control group receive stretching exercise training. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least finished primary school;
- Have normal or corrected-to-normal vision and hearing;
- Ability to do exercise;
- Right-hand dominance;
- Normal cognitive ability as assessed by the Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
Key exclusion criteria (6 listed)
- Abmormal anxiety or depression mood as measured by the Hospital Anxiety and Depression Scale;
- Current diagnosis or history of neurological or psychological conditions, such as substance abuse, psychotic disorders, or affective disorders;
- Current diagnosis or history of substance/alcohol abuse;
- Contraindications for MRI scanning (e.g. implanted metal);
- People who regularly practice any qigong, Tai Chi or similar exercise or meditation within 6 months before study;
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 |
|---|---|---|
| Qigong exerciseParticipants in the experimental group receive 12-week group-based Qigong exercise training. | Behavioural | Qigong |
| Stretching exerciseParticipants in the control group receive 12-week group-based stretching exercise training. | Behavioural | stretching |
Primary outcome
Mean change from Baseline in cognitive processing speed scores on the Symbol Digit Modalities Test at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of cognitive processing speed scores are measured by the Symbol Digit Modalities Test from baseline to end of intervention at 12 Weeks. Scores on the Symbol Digit Modalities Test range from 0-90, with a higher score indicating better performance.
Mean change from Baseline in sustained attention scores on the Continuous Performance Test at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of sustained attention scores are measured by the Continuous Performance Test from baseline to end of intervention at 12 weeks. The accuracy scores on the Continuous Performance Test range from 0-100%, with a higher score indicating better performance.
Mean change from Baseline in working memory scores on the Digit Span-Backward Test at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of working memory scores are measured by the Digit Span Backward Test from baseline to end of intervention at 12 weeks. Scores on the Digit Span-Backward test range from 2-13, with a higher score indicating better performance.
Mean change from Baseline in language scores on the Rapid Naming Test at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of language scores are measured by the Rapid Naming Test from baseline to end of intervention at 12 weeks. Scores on the Rapid Naming Test range from 0-36, with a higher score indicating better performance.
Mean change from Baseline in trait affect scores on the Chinese Affect Scale at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of trait positive affect and negative affect are measured by the Chinese Affect Scale from baseline to end of intervention at 12 weeks. Positive and negative affect scores on Chinese Affect Scale both range from 10-50, with a higher score indicating higher positive/negative affect.
Mean change from Baseline in affective processing by the Emotion Processing Task at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of affective stimuli processing are measured by the Emotion Processing Task from baseline to end of intervention at 12 weeks.
Mean change from Baseline in blood levels of cortisol at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of blood biomarker levels of cortisol are measured from baseline to end of intervention at 12 weeks.
Mean change from Baseline in blood levels of interleukin-6 at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of blood biomarker levels of interleukin-6 are measured from baseline to end of intervention at 12 weeks.
Mean change from Baseline in blood levels of brain-derived neurotrophic factor at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of blood biomarker levels of brain-derived neurotrophic factor are measured from baseline to end of intervention at 12 weeks.
Mean change from Baseline in telomerase activity at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of blood measurement of telomerase activity are measured from baseline to end of intervention at 12 weeks.
Mean change from Baseline in brain structure by magnetic resonance imaging at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of brain structure are measured by T1-weighted magnetic resonance imaging from baseline to end of intervention at 12 Weeks.
Mean change from Baseline in brain function by functional magnetic resonance imaging at 12 Weeks
Time frame: from baseline to end of intervention at 12 weeks
Changes of brain function are measured by functional magnetic resonance imaging from baseline to end of intervention at 12 Weeks.
8 secondary outcomes
Mean change from Baseline in perceived stress scores on the Perceived Stress Scale at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in insomnia severity scores on the Insomnia Severity Index at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in quality of sleep on the Pittsburg Seep Quality Index at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in depression and anxiety scores on the Hospital Anxiety and Depression Scale at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in perceived loneliness scores on the UCLA Loneliness Scale at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in quality of life scores on the WHO Quality of Life-BREF scale at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in emotion reactivity scores on the Emotion Reactivity Scale at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Mean change from Baseline in somatization scores on the somatization subscale of Symptom Check-List-90 at 12 weeks
Time frame: from baseline to end of intervention at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Derived from this study: PubMed 33872709Qi D, Wong NML, Shao R, Man ISC, Wong CHY, Yuen LP, Chan CCH, Lee TMC. Qigong exercise enhances cognitive functions in the elderly via an interleukin-6-hippocampus pathway: A randomized active-controlled trial. Brain Behav Immun. 2021 Jul;95:381-390. doi: 10.1016/j.bbi.2021.04.011. Epub 2021 Apr 17.
- Individual participant dataSharing planned: No
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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.
Tatia Lee, PhD principal investigator
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 Qigong exercise and Stretching exercise in people with Healthy Ageing, 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 5 inclusion and 6 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 23 Nov 2020. 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 Tatia Lee, PhD (852-39178394, tmclee@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline in cognitive processing speed scores on the Symbol Digit Modalities Test at 12 Weeks (time frame: from baseline to end of intervention at 12 weeks). 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 NCT04641429, 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 23 Nov 2020.