Clinical trial NCT06190327: Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults
Official title: Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: depressive symptoms
older adults
multicomponent structured exercise
blended indoor and outdoor environment
indoor exercise
connectedness to nature
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-01-05
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: This study follows a randomized controlled experimental design (RCT), parallel type with three groups and being assessed in a pretest, posttest, and after three months of the completion of the intervention. The participants will be randomly allocated to two experimental group, and one non-exercise control group. The non-exercise control group continue to maintain their daily routine and keep diaries to record . To monitor the control condition, participants will need to keep diaries to record their daily physical exercise, medicines used, illness and participation in other health-related activities. The research assistant will give telephone calls to the participants biweekly to check their diaries and identify if they change their lifestyles or experience adverse events. Two exercise groups, one group will perform multicomponent structured exercise in blended indoor and outdoor setting, the other group will conduct the same exercise only in indoor setting.
Primary purpose: TREATMENT

Brief summary: Depression is a mental health problem often occurring in the elderly. Performing physical exercise is a key element in decreasing depressive symptoms in older adults. Most studies investigating depression and physical exercise have focused on structured exercise comprise of one or two exercise components and based on the clinical patients associated with major depression. There is limited research combining multicomponent (aerobic+resistance+balance) in an exercise program and targeting non-clinical adults with depressive symptoms, with even less available for older adults.

More attention has been paid to the role of outdoor exercise on human health. Exercise in a natural environment may provide greater physiological and psychological benefits compared to indoor exercise. Findings demonstrated that green exercise provides double the beneficial effect on improving depression among adults. Although green exercise shows effects on the improvement of depression, recently a review has indicated that structured exercise programs in older adults with depressive symptoms were mainly conducted in the indoor environment. Compared with outdoor exercise which is easily influenced by the weather and with low access of available facilities, indoor exercise is more comfortable, quiet, and convenient to operate especially for older adults. Considering the high relevance between nature and mental health, the combination of indoor and outdoor exercise programs might be able to maximize intervention effectiveness while maintaining the benefits for each type of intervention.Therefore, more rigorous RCT studies in this field are needed, particularly for non-clinical older adults with depressive symptoms.

Detailed description: The 16-week double-blinded RCT (2 sessions/week, 90 min/session) will include community-dwelling older adults aged 60 to 74 years old with depressive symptoms. Participants will be randomized to one of three groups (a blended indoor and outdoor group, an indoor-only group or a control group) using 1:1:1 allocation ratio. Structured exercise training with multicomponent (aerobic, muscle strength, balance) will be conducted in two intervention groups. The intervention effects will be evaluated on depressive symptoms, physical fitness, physical activity enjoyment and connectedness to nature. All measured data will be collected at the pre-intervention, post-intervention, and 3-month follow up stages.

Eligibility criteria: Inclusion Criteria:

* 60 to 74 years at the start date of the project.
* Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-15 (i.e., mild to serve level of depressive symptoms).
* Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise.

Exclusion Criteria:

* Having cognition impairment regarded by specialists.
* are attending other health projects related to physical exercise.

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).
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).
Secondary outcomes:
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: Loneliness
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 activity enjoyment
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: Connectedness to nature
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).
Other outcomes:
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: Process evaluation of intervention program
timeFrame: Outcome evaluations will be conducted at the completion of 16-weeks intervention.
Locations:
city: Kowloon Bay
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, P.hD
role: PRINCIPAL_INVESTIGATOR
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