NCT04641429

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 12, 2020

Last Update Submit

November 20, 2020

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Mean change from Baseline in perceived stress scores on the Perceived Stress Scale at 12 weeks

    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

    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

    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

    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

    from baseline to end of intervention at 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Qigong

EXPERIMENTAL

Participants in the experimental group receive Qigong exercise training.

Behavioral: Qigong exercise

stretching

ACTIVE COMPARATOR

Participants in the control group receive stretching exercise training.

Behavioral: Stretching exercise

Interventions

Qigong exerciseBEHAVIORAL

Participants in the experimental group receive 12-week group-based Qigong exercise training.

Qigong

Participants in the control group receive 12-week group-based stretching exercise training.

stretching

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tatia Lee, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatia Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding the participants to the allocation is impossible due to the nature of intervention. But prior to the first training session, participants have no knowledge on which type of training they are going to receive.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 23, 2020

Study Start

October 2, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations