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Completed

NCT Number: NCT03591211

Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions

Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. In addition, the benefits of qigong on subjective well-being, functional independence, sleep quality, mobility, and muscle strength were also tested. After random assignment, intervention group (n = 14) went through individual qigong exercise twice a week and for 12 weeks,whereas control group (n = 16) was involved in cognitive training activities with mobilization elements. The psychosocial, physical, and neurobiological outcomes of the two groups were compared.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechinic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 60 or above
  • have been suffering from chronic medical conditions for more than one year
  • have depressive symptoms as indicated by Geriatric Depression Scale (GDS ≥ 6)

Exclusion criteria

  • have practiced or received training of any form of mind-body exercises (including tai chi, yoga, and qigong) during the 6 months prior to intervention.
  • have changed medication or the dosage prior to or during intervention
  • have obvious cognitive and language impairment or score less than 20 in Mini-Mental State Examination (MMSE)
  • undergo electroconvulsive therapy, psychotherapy, or psychoeducation
  • cannot demonstrate satisfactory sitting balance

Treatment and study plan

Qigong Training

Behavioral

Eight-Section Brocades; participants were trained individually.

Cognitive training

Behavioral

Cognitive Training of Memory and Executive Function with Activities requiring Mobilization

Primary outcomes

  1. Patient Health Questionnaire (PHQ)

    Time frame: the change from baseline to the completion of intervention (12 weeks later)

    Patient Health Questionnaire (PHQ) is used to assess the experience of depressive symptoms. The frequency of each symptom was indicated based on a 4-point scale (0 = never; 3 = almost every day). A total score ranged from 0 to 27 can be derived, with higher score indicating severer depressive symptoms.

Secondary outcomes

  1. Salivary Cortisol Level

    Time frame: baseline and 12 weeks after baseline

    measured with saliva sample obtained 5 times (07:00, 10:30, 13:00, 14:30, and 18:00) at two consecutive days at baseline and 12 weeks after baseline

  2. Brain Deprived Neurotrophic Factor (BDNF) Level

    Time frame: baseline and 12 weeks after baseline

    measured with peripheral blood samples (10 ml) collected in the morning

  3. Serotonin 5-HT Level

    Time frame: baseline and 12 weeks after baseline

    measured with serum extracted from blood samples. Around 2-3 ml of serum is harvested per 5 ml of blood.

  4. Depression Anxiety Stress Scale (DASS-21)

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    Depression Anxiety Stress Scale (DASS-21) is a 21-item scale to measure symptoms of depression, anxiety, and stress with 7 items for each. Each item is measured with 4-point from 0 (never) to 3 (almost always). The scores of depression, anxiety, and stress are the sum of all subscale items, and it can range from 0 to 21. Higher score shows more severity of depression, anxiety, and stress.

  5. Personal Well-Being Index (PWI)

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    It is measured by the 8-item scale of Personal Well-Being Index (PWI). Each item was rated according to an 11-point scale ranging from '0' (extremely dissatisfied) to '10' (extremely satisfied). An overall score of PWI score was the sum of all items. The overall score ranges from 0 to 110, with higher score indicating higher subjective well-being.

  6. Functional Independence Measure (FIM)

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    It is measured by the 18-item scale of Functional Independence Measure (FIM). Based on a 7-point scale for rating (1

    = totally unable; 7 = totally independent), a total score of FIM ranges from 18 to 126 was generated. Higher total score indicates less disability.

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    It is measured by the Pittsburgh Sleep Quality Index (PSQI). It has 19 items measuring 7 components of sleep quality, and a total score is calculated as the sum of all the component scores. The total score ranges from 0 to 21, with lower score showing better sleep quality.

  8. Timed up and Go Test (TUG)

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    Timed up and Go Test (TUG) is used to measure mobility. During the test, participants were sitting on a chair, and then they were required to stand up, walk to a mark which is 3 meters away from the chair, go back to the chair from the mark, and sit down again. The time each participant spent to complete the above series of actions was recorded.

    Participants performed the test for three times, and their final scores were the average of the three. And lower score indicates better mobility.

  9. Handgrip Strength

    Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline

    It is measured with a Jamar handheld dynamometer. Participants performed three trials of left hand and right hand grip strength, and the final outcome of each hand was calculated as the mean performance of the three trials. Higher score indicates stronger handgrip strength.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Fujian University of Traditional Chinese Medicine
  • I-Shou University

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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