LKS Faculty of Medicine
Hong Kong
NCT Number: NCT04354922
Aerobic exercise intervention for depression was conventionally recommended three times weekly with moderate intensity in previous studies, but little is known about the training effect of aerobic exercise at low frequency and vigorous intensity. The purpose of this study is to compare the training effect of aerobic exercise at different exercising frequencies and intensities on older adults with comorbid insomnia and depressive symptoms. In this study, the investigators will investigate two types of aerobic exercise (i.e., vigorous-intensity exercise and moderate-intensity exercise) under different exercising frequencies (i.e., regular exercising pattern and weekend warrior). Individuals with chronic insomnia and depressive symptoms will be recruited and randomly allocated into 5 groups: 1) attention control group (stretching exercise), 2) moderate intensity exercise performed thrice weekly (MIE×3/wk), 3) moderate intensity exercise performed once weekly (MIE×1/wk), 4) vigorous intensity exercise performed thrice weekly (VIE×3/wk), and 5) vigorous intensity exercise performed once weekly (VIE×1/wk). Intervention will be maintained for 12 weeks. Outcome assessments will be conducted at baseline, 6 weeks and 12 weeks after the intervention. Outcomes including depressive status, chronic insomnia, objective sleep quality and pattern (measured by Actigraphy), subjective sleep quality (measured by Epworth sleepiness scale, insomnia severity index, PSQI), anxiety status (measured by HADS and GAD-7), quality of life (measured by SF-12), attention level (measured by computer attention test), exercise enjoyment (measured by physical activity enjoyment scale), habitual physical activity level (measured by IPAQ), aerobic fitness (measured by metabolic cart), body adiposity (measured by DXA), blood chemistry, adherence, medication usage, and adverse events will be measure in this study. This proposed study will provide pilot evidence for the benefits, effectiveness, safety, adherence, and sustainability of low-frequency vigorous aerobic exercise. the investigators expect the low-frequency exercise modality will enhance the practical suitability of aerobic exercise and will provide evidence for weekend warrior aerobic training strategy as a new exercise option in the management of elderly insomnia and depression.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly. All walking exercise session will be performed on motor-driven treadmill. Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs). Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs). Warm-up and cool-down will be provided before and after the training. Participants who failed to achieve 80% attendance will be excluded from the study. All exercise sessions were supervised by qualified athletic coach.
Time frame: After completion of the 12 weeks intervention
Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
Time frame: After completion of the 12 weeks intervention
Brief insomnia questionnaire (BIQ) will be employed to diagnose the chronic insomnia based on the DSM-5 criteria.
Time frame: After completion of the 12 weeks intervention
The Epworth sleepiness scale, insomnia severity index, and Pittsburgh sleep quality index (PSQI) will be used to measure the sleep quality.
Time frame: After completion of the 12 weeks intervention
Actigraphy will be used to measure the sleep quality and pattern.
Time frame: After completion of the 12 weeks intervention
The dose of sleep medication used by the subjects changes after intervention.
Time frame: After completion of the 12 weeks intervention
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
Time frame: After completion of the 12 weeks intervention
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Time frame: After completion of the 12 weeks intervention
Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
Time frame: After completion of the 12 weeks intervention
Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
Time frame: After completion of the 12 weeks intervention
Anxiety level will be measured by HASD and General Anxiety Disorder-7.
Time frame: After completion of the 12 weeks intervention
PHQ-9 will be used to examine the severity of depression.
Time frame: After completion of the 12 weeks intervention
biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
Time frame: After completion of the 12 weeks intervention
Measured by the 12-item Short Form Survey, scores range from 0 to 100, higher scores indicating better physical and mental health functioning
Time frame: After completion of the 12 weeks intervention
Physical activity enjoyment scale will be used to test the subject's perception of the exercise, higher scores reflect greater levels of enjoyment
Time frame: After completion of the 12 weeks intervention
Computer attention test in PsychoPy v2 software will be employed to measure the attention.
Time frame: After completion of the 12 weeks intervention
Habitual physical activity will be measured by IPAQ
The University of Hong Kong
Other
Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults
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