- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641429
Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People
November 20, 2020 updated by: Professor Tatia Mei-chun LEE, The University of Hong Kong
This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Tatia Lee, PhD
- Phone Number: 852-39178394
- Email: tmclee@hku.hk
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Principal Investigator:
- Tatia Lee, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Qigong
Participants in the experimental group receive Qigong exercise training.
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Participants in the experimental group receive 12-week group-based Qigong exercise training.
|
|
Active Comparator: stretching
Participants in the control group receive stretching exercise training.
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Participants in the control group receive 12-week group-based stretching exercise training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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
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.
|
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
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.
|
from baseline to end of intervention at 12 weeks
|
|
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.
|
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
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.
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from baseline to end of intervention at 12 weeks
|
|
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.
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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.
|
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.
|
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.
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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.
|
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.
|
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.
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from baseline to end of intervention at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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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
|
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.
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from baseline to end of intervention at 12 weeks
|
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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
|
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.
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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
|
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.
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from baseline to end of intervention at 12 weeks
|
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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
|
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.
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from baseline to end of intervention at 12 weeks
|
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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
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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.
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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
|
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.
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from baseline to end of intervention at 12 weeks
|
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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
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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.
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from baseline to end of intervention at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tatia Lee, PhD, The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2019
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
November 12, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Actual)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- UW 19-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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