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NCT Number: NCT04354922

Different Exercising Intensities and Frequencies of Exercise on Depressive Mood and Insomnia

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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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • contraindications to participating in physical exercise;
  • 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);
  • any pre-existing medical or physical issues that affect the experimental test and exercise intervention;
  • diagnosis with psychosis, schizophrenia or bipolar disorder;
  • currently receiving non-medication treatment for depression or insomnia, such as mindfulness training or cognitive behavior therapy;
  • shift worker or other commitment that interferes with the regular sleep pattern at night; and
  • abnormal heart's electrical activity according to the exercise electrocardiography (ECG) test, such as irregular heartbeat, arrhythmia, and myocardial infarction.

Treatment and study plan

Exercise Intervention

Behavioral

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.

Primary outcomes

  1. Level of depression

    Time frame: After completion of the 12 weeks intervention

    Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression

  2. Remission rate of insomnia

    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.

Secondary outcomes

  1. Subjective sleep data

    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.

  2. Objective sleep data

    Time frame: After completion of the 12 weeks intervention

    Actigraphy will be used to measure the sleep quality and pattern.

  3. Change in dose of Sleep Medication

    Time frame: After completion of the 12 weeks intervention

    The dose of sleep medication used by the subjects changes after intervention.

  4. 7-day Sleep Diary

    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)

  5. Treatment response rate

    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

  6. Body composition

    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

  7. Maximal oxygen consumption

    Time frame: After completion of the 12 weeks intervention

    Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test

  8. Anxiety level

    Time frame: After completion of the 12 weeks intervention

    Anxiety level will be measured by HASD and General Anxiety Disorder-7.

  9. Severity of depression

    Time frame: After completion of the 12 weeks intervention

    PHQ-9 will be used to examine the severity of depression.

  10. Blood chemistry tests

    Time frame: After completion of the 12 weeks intervention

    biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa

  11. Subjectively measured quality of life

    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

  12. Enjoyment of exercise intervention

    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

  13. Attention level

    Time frame: After completion of the 12 weeks intervention

    Computer attention test in PsychoPy v2 software will be employed to measure the attention.

  14. Habitual physical activity

    Time frame: After completion of the 12 weeks intervention

    Habitual physical activity will be measured by IPAQ

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Feb 1, 2022

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

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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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