Clinical trial NCT04354922: Different Exercising Intensities and Frequencies of Exercise on Depressive Mood and Insomnia
Official title: Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Depressive Symptoms
Keywords: Insomnia
Mood
Exercise
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5 groups ×2 times factorial design
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. borderline abnormal depression with score above 8 out of 21 on Hospital Anxiety and Depression Scale (HADS),
2. chronic insomnia according to the fifth edition of the diagnostic and statistical manual of mental disorder (DSM-5),
3. Cantonese, Mandarin or English speaking, and 4) age 50 or above. To enhance generalizability, males and females will be recruited.

Exclusion Criteria:

1. contraindications to participating in physical exercise;
2. regular exercise habit in the past three months (i.e.,\>75 minutes of vigorous-intensity exercise weekly or \>150 minutes of moderate-intensity exercise weekly);
3. any pre-existing medical or physical issues that affect the experimental test and exercise intervention;
4. diagnosis with psychosis, schizophrenia or bipolar disorder;
5. currently receiving non-medication treatment for depression or insomnia, such as mindfulness training or cognitive behavior therapy;
6. shift worker or other commitment that interferes with the regular sleep pattern at night; and
7. abnormal heart's electrical activity according to the exercise electrocardiography (ECG) test, such as irregular heartbeat, arrhythmia, and myocardial infarction.

Primary outcomes:
measure: Level of depression
timeFrame: After completion of the 12 weeks intervention
measure: Remission rate of insomnia
timeFrame: After completion of the 12 weeks intervention
Secondary outcomes:
measure: Subjective sleep data
timeFrame: After completion of the 12 weeks intervention
measure: Objective sleep data
timeFrame: After completion of the 12 weeks intervention
measure: Change in dose of Sleep Medication
timeFrame: After completion of the 12 weeks intervention
measure: 7-day Sleep Diary
timeFrame: After completion of the 12 weeks intervention
measure: Treatment response rate
timeFrame: After completion of the 12 weeks intervention
measure: Body composition
timeFrame: After completion of the 12 weeks intervention
measure: Maximal oxygen consumption
timeFrame: After completion of the 12 weeks intervention
measure: Anxiety level
timeFrame: After completion of the 12 weeks intervention
measure: Severity of depression
timeFrame: After completion of the 12 weeks intervention
measure: Blood chemistry tests
timeFrame: After completion of the 12 weeks intervention
measure: Subjectively measured quality of life
timeFrame: After completion of the 12 weeks intervention
measure: Enjoyment of exercise intervention
timeFrame: After completion of the 12 weeks intervention
measure: Attention level
timeFrame: After completion of the 12 weeks intervention
measure: Habitual physical activity
timeFrame: After completion of the 12 weeks intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LKS Faculty of Medicine
Study officials:
References:
citation: Chin EC, Yu AP, Leung CK, Bernal JD, Au WW, Fong DY, Cheng CP, Siu PM. Effects of Exercise Frequency and Intensity on Reducing Depressive Symptoms in Older Adults With Insomnia: A Pilot Randomized Controlled Trial. Front Physiol. 2022 Apr 5;13:863457. doi: 10.3389/fphys.2022.863457. eCollection 2022.