Clinical trial NCT06014294: Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults
Official title: Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults With Mild and Moderate Depression: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: Depressive symptoms
Older adults
High-intensity interval training
Baduanjin Qigong
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present research follows a cluster randomized controlled experimental design (CRCT), parallel type with three groups in multi-centers and being assessed in a pretest, posttest, and after three months of the completion of the intervention. The participants will be randomly allocated to one experimental group, one exercise control group, and one non-exercise control group. The non-exercise control group continue to maintain their daily routine and will be asked to attend workshop. While two exercise groups, one group performs a HIIT program, and the other group performs a Baduanjin exercise program.
Primary purpose: TREATMENT

Brief summary: Depression in later life is a common health problem in aging societies. It is associated with poor quality of life, and increased risks of morbidity and mortality. People with severe depression may develop serious psychotic symptoms (e.g., delusions) and have higher mortality and disability than those with mild and moderate depression.

Traditional moderate-intensity continuous training (MICT) (e.g., Baduanjin Qigong) has proved to be effective in preventing and alleviating depressive symptoms among older adults. However, older adults with mental illnesses have poorer engagement and compliance with MICT programs. In recent years, as a novel type of exercise, high-intensity interval training (HIIT), which includes repeated bouts of high-intensity effort followed by varied recovery times, appears to be a promising approach for overcoming limitations in traditional MICT programs.

Considering there is little evidence of HIIT benefits related to older adults with depression, the current study aims to evaluate the effectiveness of a 16-week HIIT intervention on depressive symptoms and other health-related outcomes among Hong Kong Chinese older adults.

Detailed description: The study will be a cluster randomized controlled trial (CRCT) with three groups and three times repeated measures. Data will be collected in a pretest, post-test, and three months after the intervention. The eligible community elderly centers will be randomly distributed into one of three groups in a ratio of 1:1:1. The participants recruited and meeting the screening criteria will receive a 16-week HIIT intervention or Baduanjin exercise or recreation workshop. The intervention effects will be evaluated on depressive symptoms, concentration of salivary cortisol, sleep quality, quality of life, and physical fitness.

Eligibility criteria: Inclusion Criteria:

* 60 to 74 years at the start date of the project
* Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-11 (i.e., mild to moderate level of depressive symptoms)
* Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise
* Above the average level of 2-mins stepping showing competent aerobic fitness
* No restriction on physical mobility
* No cognitive impairment, as determined by the Chinese version of the Mini-Mental Status Examination (i.e., score \< 24)
* No previous substantial experiences in practicing HIIT or Baduanjin Qigong. The written informed consent form will be collected from each participant

Exclusion Criteria:

* Severe chronic disease restricting high-intensity exercise
* Having cognition impairment regarded by specialists

Primary outcomes:
measure: Self-reported depressive symptoms
timeFrame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Secondary outcomes:
measure: Concentration of saliva cortisol
timeFrame: Evaluations of concentration of saliva cortisol will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
measure: Physical fitness
timeFrame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
measure: Sleep quality
timeFrame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
measure: Perceived quality of life
timeFrame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 16-weeks intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Other outcomes:
measure: Heart rate
timeFrame: Heart rate will be monitored from the start of warm-up to the end of cool-down at each exercise session during the 16-weeks exercise intervention.
measure: Self-reported Rate of Perceived Exertion (RPE)
timeFrame: RPE will be asked at the end of main exercise at each exercise session during the 16-weeks intervention.
measure: Safety: adverse events
timeFrame: Adverse events will be asked at the end of each exercise session during the 16-weeks intervention program.
measure: Exercise acceptability
timeFrame: Outcome evaluations will be conducted at the completion of 16-weeks intervention.
measure: Process evaluation of intervention program
timeFrame: Outcome evaluations will be conducted at the completion of 16-weeks intervention.
Locations:
city: Hong Kong
country: Hong Kong
facility: Bliss District Elderly Community Centre
Study officials:
affiliation: Hong Kong Baptist Univeristy; Department of Sport, Physical Education and Health
name: Yanping Duan
role: PRINCIPAL_INVESTIGATOR
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