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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tatia Lee, PhD
  • Phone Number: 852-39178394
  • Email: tmclee@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least finished primary school;
  2. Have normal or corrected-to-normal vision and hearing;
  3. Ability to do exercise;
  4. Right-hand dominance;
  5. Normal cognitive ability as assessed by the Montreal Cognitive Assessment Hong Kong version (HK-MoCA).

Exclusion Criteria:

  1. Abmormal anxiety or depression mood as measured by the Hospital Anxiety and Depression Scale;
  2. Current diagnosis or history of neurological or psychological conditions, such as substance abuse, psychotic disorders, or affective disorders;
  3. Current diagnosis or history of substance/alcohol abuse;
  4. Contraindications for MRI scanning (e.g. implanted metal);
  5. People who regularly practice any qigong, Tai Chi or similar exercise or meditation within 6 months before study;
  6. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Qigong
Participants in the experimental group receive Qigong exercise training.
Behavioral: Qigong exercise
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.
Behavioral: Stretching exercise
Participants in the control group receive 12-week group-based stretching exercise training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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.
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.
from baseline to end of intervention at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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
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.
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.
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
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.
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
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.
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.
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
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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