Clinical trial NCT04641429: Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People
Official title: Neuroplasticity: The Effects of Exercise Training on Cognitive and Affective Functioning of Older People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Ageing
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from Baseline in cognitive processing speed scores on the Symbol Digit Modalities Test at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in sustained attention scores on the Continuous Performance Test at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in working memory scores on the Digit Span-Backward Test at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in language scores on the Rapid Naming Test at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in trait affect scores on the Chinese Affect Scale at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in affective processing by the Emotion Processing Task at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in blood levels of cortisol at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in blood levels of interleukin-6 at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in blood levels of brain-derived neurotrophic factor at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in telomerase activity at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in brain structure by magnetic resonance imaging at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in brain function by functional magnetic resonance imaging at 12 Weeks
timeFrame: from baseline to end of intervention at 12 weeks
Secondary outcomes:
measure: Mean change from Baseline in perceived stress scores on the Perceived Stress Scale at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in insomnia severity scores on the Insomnia Severity Index at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in quality of sleep on the Pittsburg Seep Quality Index at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in depression and anxiety scores on the Hospital Anxiety and Depression Scale at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in perceived loneliness scores on the UCLA Loneliness Scale at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in quality of life scores on the WHO Quality of Life-BREF scale at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in emotion reactivity scores on the Emotion Reactivity Scale at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
measure: Mean change from Baseline in somatization scores on the somatization subscale of Symptom Check-List-90 at 12 weeks
timeFrame: from baseline to end of intervention at 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Tatia Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.