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

Primary Purpose

Sleep Disorder, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring Insomnia, Mood, Exercise

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LKS Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Attention control

Moderate-intensity walking exercise ×3/wk

Moderate-intensity walking exercise ×1/wk

Vigorous-intensity walking exercise ×3/wk

Vigorous-intensity walking exercise ×1/wk

Arm Description

Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period

Subjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period

Subjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period

Subjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period

Subjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period

Outcomes

Primary Outcome Measures

Level of depression
Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
Remission rate of insomnia
Brief insomnia questionnaire (BIQ) will be employed to diagnose the chronic insomnia based on the DSM-5 criteria.

Secondary Outcome Measures

Subjective sleep data
The Epworth sleepiness scale, insomnia severity index, and Pittsburgh sleep quality index (PSQI) will be used to measure the sleep quality.
Objective sleep data
Actigraphy will be used to measure the sleep quality and pattern.
Change in dose of Sleep Medication
The dose of sleep medication used by the subjects changes after 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)
Treatment response rate
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Body composition
Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
Maximal oxygen consumption
Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
Anxiety level
Anxiety level will be measured by HASD and General Anxiety Disorder-7.
Severity of depression
PHQ-9 will be used to examine the severity of depression.
Blood chemistry tests
biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
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
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
Attention level
Computer attention test in PsychoPy v2 software will be employed to measure the attention.
Habitual physical activity
Habitual physical activity will be measured by IPAQ

Full Information

First Posted
April 17, 2020
Last Updated
January 17, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04354922
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Depressive Symptoms
Keywords
Insomnia, Mood, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
5 groups ×2 times factorial design
Masking
Outcomes Assessor
Masking Description
Single-blind (Outcome Assessor)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period
Arm Title
Moderate-intensity walking exercise ×3/wk
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
Arm Title
Moderate-intensity walking exercise ×1/wk
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
Arm Title
Vigorous-intensity walking exercise ×3/wk
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
Arm Title
Vigorous-intensity walking exercise ×1/wk
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
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 Outcome Measure Information:
Title
Level of depression
Description
Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
Time Frame
After completion of the 12 weeks intervention
Title
Remission rate of insomnia
Description
Brief insomnia questionnaire (BIQ) will be employed to diagnose the chronic insomnia based on the DSM-5 criteria.
Time Frame
After completion of the 12 weeks intervention
Secondary Outcome Measure Information:
Title
Subjective sleep data
Description
The Epworth sleepiness scale, insomnia severity index, and Pittsburgh sleep quality index (PSQI) will be used to measure the sleep quality.
Time Frame
After completion of the 12 weeks intervention
Title
Objective sleep data
Description
Actigraphy will be used to measure the sleep quality and pattern.
Time Frame
After completion of the 12 weeks intervention
Title
Change in dose of Sleep Medication
Description
The dose of sleep medication used by the subjects changes after intervention.
Time Frame
After completion of the 12 weeks intervention
Title
7-day Sleep Diary
Description
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
Time Frame
After completion of the 12 weeks intervention
Title
Treatment response rate
Description
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Time Frame
After completion of the 12 weeks intervention
Title
Body composition
Description
Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
Time Frame
After completion of the 12 weeks intervention
Title
Maximal oxygen consumption
Description
Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
Time Frame
After completion of the 12 weeks intervention
Title
Anxiety level
Description
Anxiety level will be measured by HASD and General Anxiety Disorder-7.
Time Frame
After completion of the 12 weeks intervention
Title
Severity of depression
Description
PHQ-9 will be used to examine the severity of depression.
Time Frame
After completion of the 12 weeks intervention
Title
Blood chemistry tests
Description
biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
Time Frame
After completion of the 12 weeks intervention
Title
Subjectively measured quality of life
Description
Measured by the 12-item Short Form Survey, scores range from 0 to 100, higher scores indicating better physical and mental health functioning
Time Frame
After completion of the 12 weeks intervention
Title
Enjoyment of exercise intervention
Description
Physical activity enjoyment scale will be used to test the subject's perception of the exercise, higher scores reflect greater levels of enjoyment
Time Frame
After completion of the 12 weeks intervention
Title
Attention level
Description
Computer attention test in PsychoPy v2 software will be employed to measure the attention.
Time Frame
After completion of the 12 weeks intervention
Title
Habitual physical activity
Description
Habitual physical activity will be measured by IPAQ
Time Frame
After completion of the 12 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
LKS Faculty of Medicine
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35450161
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.
Results Reference
derived

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

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