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

NCT04354922 | Completed

• 1 other identifier: DI
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Depressive Symptoms

Keywords

Insomnia; Mood; Exercise

Outcome Measures

Primary Outcomes (2)

• Level of depression

  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

  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

Secondary Outcomes (14)

• Subjective sleep data

  After completion of the 12 weeks intervention

• Objective sleep data

  After completion of the 12 weeks intervention

• Change in dose of Sleep Medication

  After completion of the 12 weeks intervention

• 7-day Sleep Diary

  After completion of the 12 weeks intervention

• Treatment response rate

  After completion of the 12 weeks intervention

Study Arms (5)

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

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

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

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

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

Behavioral: Exercise intervention

Interventions

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.

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35450161 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Depression; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 5 groups ×2 times factorial design

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: January 31, 2019
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2021-07

Locations

HK (1)