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

17. januar 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • LKS Faculty of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Attention control
Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period
Adfærdsmæssigt: Exercise intervention
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.
Aktiv komparator: 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
Adfærdsmæssigt: Exercise intervention
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.
Aktiv komparator: 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
Adfærdsmæssigt: Exercise intervention
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.
Aktiv komparator: 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
Adfærdsmæssigt: Exercise intervention
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.
Aktiv komparator: 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
Adfærdsmæssigt: Exercise intervention
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of depression
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective sleep data
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: After completion of the 12 weeks intervention
Habitual physical activity will be measured by IPAQ
After completion of the 12 weeks intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Hong Kong

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. januar 2019

Primær færdiggørelse (Faktiske)

30. september 2021

Studieafslutning (Faktiske)

31. oktober 2021

Datoer for studieregistrering

Først indsendt

17. april 2020

Først indsendt, der opfyldte QC-kriterier

17. april 2020

Først opslået (Faktiske)

21. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. januar 2022

Sidst verificeret

1. juli 2021

Mere information

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Nøgleord

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Andre undersøgelses-id-numre

  • DI

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