Sleep DisorderNCT04354922
Different Exercising Intensities and Frequencies of Exercise on Depressive Mood and Insomnia
A study testing Exercise intervention in people with Sleep Disorder and Depressive Symptoms, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Disorder, Depressive Symptoms
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults
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.
- Conditions
- Sleep Disorder, Depressive Symptoms
- Being tested
- Exercise intervention
- Keywords
- Insomnia, Mood, Exercise
- Medical subject headings
- Sleep Wake Disorders, Depression, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention control | Placebo comparator | Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period Receives: Behavioral: Exercise intervention |
| Moderate-intensity walking exercise ×3/wk | Active comparator | Subjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period Receives: Behavioral: Exercise intervention |
| Moderate-intensity walking exercise ×1/wk | Active comparator | Subjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period Receives: Behavioral: Exercise intervention |
| Vigorous-intensity walking exercise ×3/wk | Active comparator | Subjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period Receives: Behavioral: Exercise intervention |
| Vigorous-intensity walking exercise ×1/wk | Active comparator | Subjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression
Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
Measured: After completion of the 12 weeks intervention
Remission rate of insomnia
Brief insomnia questionnaire (BIQ) will be employed to diagnose the chronic insomnia based on the DSM-5 criteria.
Measured: After completion of the 12 weeks intervention
Secondary outcomes (14)
Subjective sleep data
The Epworth sleepiness scale, insomnia severity index, and Pittsburgh sleep quality index (PSQI) will be used to measure the sleep quality.
Measured: After completion of the 12 weeks intervention
Objective sleep data
Actigraphy will be used to measure the sleep quality and pattern.
Measured: After completion of the 12 weeks intervention
Change in dose of Sleep Medication
The dose of sleep medication used by the subjects changes after intervention.
Measured: After completion of the 12 weeks intervention
7-day Sleep Diary
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
Measured: After completion of the 12 weeks intervention
Treatment response rate
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Measured: After completion of the 12 weeks intervention
Body composition
Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
Measured: After completion of the 12 weeks intervention
Maximal oxygen consumption
Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
Measured: After completion of the 12 weeks intervention
Anxiety level
Anxiety level will be measured by HASD and General Anxiety Disorder-7.
Measured: After completion of the 12 weeks intervention
Severity of depression
PHQ-9 will be used to examine the severity of depression.
Measured: After completion of the 12 weeks intervention
Blood chemistry tests
biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
Measured: After completion of the 12 weeks intervention
Subjectively measured quality of life
Measured by the 12-item Short Form Survey, scores range from 0 to 100, higher scores indicating better physical and mental health functioning
Measured: After completion of the 12 weeks intervention
Enjoyment of exercise intervention
Physical activity enjoyment scale will be used to test the subject's perception of the exercise, higher scores reflect greater levels of enjoyment
Measured: After completion of the 12 weeks intervention
Attention level
Computer attention test in PsychoPy v2 software will be employed to measure the attention.
Measured: After completion of the 12 weeks intervention
Habitual physical activity
Habitual physical activity will be measured by IPAQ
Measured: After completion of the 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start31 Jan 2019
- Primary completion30 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 5 groups ×2 times factorial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354922
- Sponsor's protocol ID
- DI
- Status last verified
- Jul 2021
- First submitted
- 17 Apr 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35450161
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults
- ClinicalTrials.gov ID
- NCT04354922
- Acronym / sponsor ID
- DI
- Conditions
- Sleep Disorder, Depressive Symptoms
- Keywords
- Insomnia, Mood, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- 5 groups ×2 times factorial design
| Arm | Type | Receives |
|---|---|---|
| Attention control | Placebo comparator | Behavioral: Exercise interventionSubjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period |
| Moderate-intensity walking exercise ×3/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period |
| Moderate-intensity walking exercise ×1/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period |
| Vigorous-intensity walking exercise ×3/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period |
| Vigorous-intensity walking exercise ×1/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionSubjects 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. | Behavioural | Attention control, Moderate-intensity walking exercise ×1/wk, Moderate-intensity walking exercise ×3/wk, Vigorous-intensity walking exercise ×1/wk, Vigorous-intensity walking exercise ×3/wk |
Primary outcome
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
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.
14 secondary outcomes
Subjective sleep data
Time frame: After completion of the 12 weeks intervention
Objective sleep data
Time frame: After completion of the 12 weeks intervention
Change in dose of Sleep Medication
Time frame: After completion of the 12 weeks intervention
7-day Sleep Diary
Time frame: After completion of the 12 weeks intervention
Treatment response rate
Time frame: After completion of the 12 weeks intervention
Body composition
Time frame: After completion of the 12 weeks intervention
Maximal oxygen consumption
Time frame: After completion of the 12 weeks intervention
Anxiety level
Time frame: After completion of the 12 weeks intervention
Severity of depression
Time frame: After completion of the 12 weeks intervention
Blood chemistry tests
Time frame: After completion of the 12 weeks intervention
Subjectively measured quality of life
Time frame: After completion of the 12 weeks intervention
Enjoyment of exercise intervention
Time frame: After completion of the 12 weeks intervention
Attention level
Time frame: After completion of the 12 weeks intervention
Habitual physical activity
Time frame: After completion of the 12 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 35450161Chin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Sleep Disorder and Depressive Symptoms, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depression (time frame: After completion of the 12 weeks intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.