Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People

Healthy Ageing Clinical Trial

Official title:

Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641429
• Other study ID #: UW 19-005
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: October 2021

Study information

• Verified date: November 2020
• Source: The University of Hong Kong
• Contact: Tatia Lee, PhD
• Phone: 852-39178394
• Email: tmclee[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the effects of exercise on older people's cognitive and affective functions, and the possible underlying neurobiological pathways.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Ageing

Intervention

Behavioral:
• Qigong exercise
Participants in the experimental group receive 12-week group-based Qigong exercise training.
• Stretching exercise
Participants in the control group receive 12-week group-based stretching exercise training.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Primary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks
Secondary	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.	from baseline to end of intervention at 12 weeks