Different Exercising Intensities and Frequencies of Exercise on Depressive Mood and Insomnia
2022年1月17日 更新者：The University of Hong Kong
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.
調査の概要
研究の種類
介入
入学 (実際)
75
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Hong Kong、香港
- LKS Faculty of Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Attention control
Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period
|
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.
|
|
アクティブコンパレータ：Moderate-intensity walking exercise ×3/wk
Subjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
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.
|
|
アクティブコンパレータ：Moderate-intensity walking exercise ×1/wk
Subjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
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.
|
|
アクティブコンパレータ：Vigorous-intensity walking exercise ×3/wk
Subjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
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.
|
|
アクティブコンパレータ：Vigorous-intensity walking exercise ×1/wk
Subjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Level of depression
時間枠：After completion of the 12 weeks intervention
|
Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
|
After completion of the 12 weeks intervention
|
|
Remission rate of insomnia
時間枠：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.
|
After completion of the 12 weeks intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjective sleep data
時間枠：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.
|
After completion of the 12 weeks intervention
|
|
Objective sleep data
時間枠：After completion of the 12 weeks intervention
|
Actigraphy will be used to measure the sleep quality and pattern.
|
After completion of the 12 weeks intervention
|
|
Change in dose of Sleep Medication
時間枠：After completion of the 12 weeks intervention
|
The dose of sleep medication used by the subjects changes after intervention.
|
After completion of the 12 weeks intervention
|
|
7-day Sleep Diary
時間枠：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)
|
After completion of the 12 weeks intervention
|
|
Treatment response rate
時間枠：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
|
After completion of the 12 weeks intervention
|
|
Body composition
時間枠：After completion of the 12 weeks intervention
|
Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
|
After completion of the 12 weeks intervention
|
|
Maximal oxygen consumption
時間枠：After completion of the 12 weeks intervention
|
Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
|
After completion of the 12 weeks intervention
|
|
Anxiety level
時間枠：After completion of the 12 weeks intervention
|
Anxiety level will be measured by HASD and General Anxiety Disorder-7.
|
After completion of the 12 weeks intervention
|
|
Severity of depression
時間枠：After completion of the 12 weeks intervention
|
PHQ-9 will be used to examine the severity of depression.
|
After completion of the 12 weeks intervention
|
|
Blood chemistry tests
時間枠：After completion of the 12 weeks intervention
|
biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
|
After completion of the 12 weeks intervention
|
|
Subjectively measured quality of life
時間枠：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
|
After completion of the 12 weeks intervention
|
|
Enjoyment of exercise intervention
時間枠：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
|
After completion of the 12 weeks intervention
|
|
Attention level
時間枠：After completion of the 12 weeks intervention
|
Computer attention test in PsychoPy v2 software will be employed to measure the attention.
|
After completion of the 12 weeks intervention
|
|
Habitual physical activity
時間枠：After completion of the 12 weeks intervention
|
Habitual physical activity will be measured by IPAQ
|
After completion of the 12 weeks intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年1月31日
一次修了 (実際)
2021年9月30日
研究の完了 (実際)
2021年10月31日
試験登録日
最初に提出
2020年4月17日
QC基準を満たした最初の提出物
2020年4月17日
最初の投稿 (実際)
2020年4月21日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月1日
QC基準を満たした最後の更新が送信されました
2022年1月17日
最終確認日
2021年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。