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Depressive SymptomsNCT06190327

Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults

A study testing Blended indoor and outdoor multicomponent structured exercise and Indoor-only multicomponent structured exercise in people with Depressive Symptoms, run by Hong Kong Baptist University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms
What is being tested?
Blended indoor and outdoor multicomponent structured exercise and Indoor-only multicomponent structured exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteHong Kong
Study dates
1 Apr 2023to 3 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Yanping Duan, P.hD contact

34115638

duanyp@hkbu.edu.hk

Hong Kong1 site, 1 recruiting

  • Bliss District Elderly Community Centre

    Kowloon Bay

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults: a Randomized Controlled Trial

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.

Read the 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.

Being tested
Blended indoor and outdoor multicomponent structured exercise, Indoor-only multicomponent structured exercise
Keywords
depressive symptoms, older adults, multicomponent structured exercise, blended indoor and outdoor environment, indoor exercise, connectedness to nature
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blended indoor and outdoor multicomponent structured exerciseBehavioural

    Participants will receive a 16-week blended indoor and outdoor multicomponent structured exercise program, with 2 sessions per week (90 mins/session). Session 1/week will conduct in indoor setting, while session 2/week will conducted in outdoor setting (park). Each session will comprise 10-min warm-up, 30-min aerobic training, 20-min muscle strength, 20-min postural balance training, and 10-min cool-down.

  • Indoor-only multicomponent structured exerciseBehavioural

    Participants will receive a 16-week indoor-only multicomponent structured exercise program, with 2 sessions per week (90 mins/session). Both two sessions will conducted in indoor setting. Each session will comprise 10-min warm-up, 30-min aerobic training, 20-min muscle strength, 20-min postural balance training, and 10-min cool-down.

Study groups in NCT06190327
Study groupRoleWhat they receive
blended indoor and outdoor multicomponent structured exercise groupExperimentalParticipants will receive a 16-week blended indoor and outdoor multicomponent structured exercise program, with 2 sessions per week (90 mins/session).
Receives: Behavioral: Blended indoor and outdoor multicomponent structured exercise
indoor-only multicomponent structured exercise groupActive comparatorParticipants will receive a 16-week indoor-only multicomponent structured exercise program, with 2 sessions per week (90 mins/session).
Receives: Behavioral: Indoor-only multicomponent structured exercise
control groupNo interventionThe control group will not receive any intervention during the whole project.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported depressive symptoms

    The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).

    Measured: 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).

  2. Concentration of saliva cortisol

    Objective biomarker of depression will be measured in salivary cortisol. All participants will be provided with three salivette tubes and be asked to collect the saliva samples (2-3 ml) at awakening and 30 mins after awakening, respectively. All saliva samples for all subjects will be collected at the same time of day and samples will not be taken on days in which participants are sick with a fever. The salivette tubes will be stored in the freezer zone until to be tested. ELISA KIT protocol will be used to be followed to collect and analyze the samples in each assessment.

    Measured: 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 (4)

  1. Physical fitness

    Physical fitness will be assessed using the Senior Fitness Test (SFT) battery. There are seven testing items measuring all five dimensions, including the body mass index (BMI), 30s chair stand for lower limbs' muscle strength, 30s arm curl for upper limbs' muscle strength, 2-min step test for aerobic endurance, chair sit-and-reach test for lower body flexibility, back scratch test for upper body flexibility, and 8ft up-and-go test for mobility and dynamic balance.

    Measured: 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).

  2. Loneliness

    The 6-item De Jong Gierveld Loneliness Scale with Chinese version will be applied for assessing loneliness. This scale has been shown a sound reliability and validity for older adults in Hong Kong (Cronbach's alpha=0.76). Item 1 to item 3 as negatively worded items will be measured "emotional loneliness", answer "yes" will score 1, answer "more or less" will score 1, answer "no" will score 0. Item 4 to item 6 as positively worded items will be used to assessed "social loneliness", answer "yes" will score 0, answer "more or less" will score 1, answer "no" will score 1.

    Measured: 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).

  3. Physical activity enjoyment

    The Chinese version of the 8-item physical activity enjoyment scale (PACES) will be measured participant's enjoyment level after engaging in blended indoor and outdoor multicomponent exercise program. This scale has revealed strong internal consistency and reliability among Hong Kong older adults (Cronbach's alpha=0.92). It will be scored by 7 bipolar rating, from one extreme to the other extreme, for example, from "it's very pleasant" to "it's very unpleasant".

    Measured: 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).

  4. Connectedness to nature

    The 14-item connectedness to nature scale (CNS) with Chinese version will be used to measure the sense of belonging to the natural world. This five-point scale, ranging from 1 "strongly disagree" to 5 "strongly agree".

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start1 Apr 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion3 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06190327
Sponsor's protocol ID
05200098
Status last verified
Dec 2023
First submitted
19 Dec 2023
Last updated
5 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wei J, Hou R, Zhang X, Xu H, Xie L, Chandrasekar EK, Ying M, Goodman M. The association of late-life depression with all-cause and cardiovascular mortality among community-dwelling older adults: systematic review and meta-analysis. Br J Psychiatry. 2019 Aug;215(2):449-455. doi: 10.1192/bjp.2019.74. Epub 2019 Apr 10.

    PubMed 30968781

  • Cheung KCK, Chou KL. Poverty, deprivation, and depressive symptoms among older adults in Hong Kong. Aging Ment Health. 2019 Jan;23(1):22-29. doi: 10.1080/13607863.2017.1394438. Epub 2017 Oct 31.

    PubMed 29086588

  • Zhao SZ, Wong JYH, Luk TT, Wai AKC, Lam TH, Wang MP. Mental health crisis under COVID-19 pandemic in Hong Kong, China. Int J Infect Dis. 2020 Nov;100:431-433. doi: 10.1016/j.ijid.2020.09.030. Epub 2020 Sep 16.

    PubMed 32947051

  • Teychenne M, Ball K, Salmon J. Sedentary behavior and depression among adults: a review. Int J Behav Med. 2010 Dec;17(4):246-54. doi: 10.1007/s12529-010-9075-z.

    PubMed 20174982

  • Catalan-Matamoros D, Gomez-Conesa A, Stubbs B, Vancampfort D. Exercise improves depressive symptoms in older adults: An umbrella review of systematic reviews and meta-analyses. Psychiatry Res. 2016 Oct 30;244:202-9. doi: 10.1016/j.psychres.2016.07.028. Epub 2016 Jul 22.

    PubMed 27494042

  • Eigenschenk B, Thomann A, McClure M, Davies L, Gregory M, Dettweiler U, Ingles E. Benefits of Outdoor Sports for Society. A Systematic Literature Review and Reflections on Evidence. Int J Environ Res Public Health. 2019 Mar 15;16(6):937. doi: 10.3390/ijerph16060937.

    PubMed 30875938

  • Askari J, Saberi-Kakhki A, Yassini SM. The Effect of Aerobic Indoor Exercise Compared with Green Exercise on Different Symptoms of Depression: An Investigation of Psychological Mediators of Stress and Coping. Open Journal of Medical Psychology. 2017 Jul 3;6(03):197.

  • Li N, Wu J. Revise of the Connectedness to Nature Scale and its Reliability and Validity. China Journal of Health Psychology. 2016 Mar 22;24(9):1347-50.

  • Loureiro A, Veloso TJ. Outdoor exercise, well-being and connectedness to nature. Psico. 2014 Mar;45(3):299-304.

  • Cheng ST, Chan AC. A brief version of the geriatric depression scale for the chinese. Psychol Assess. 2004 Jun;16(2):182-6. doi: 10.1037/1040-3590.16.2.182.

    PubMed 15222814

  • Chiu HF, Lee H, Chung W, Kwong P. Reliability and validity of the Cantonese version of mini-mental state examination-a preliminary study. Hong Kong Journal of Psychiatry. 1994;4(2):25.

  • Chung PK, Zhao YN, Quach, B, Liu JD. The Use of the Cantonese Rating of Perceived Exertion Scale in Older People. Proceedings of the 12th SCSEPF Annual Conference. 2013.

  • Chung PK, Leung KM. Psychometric Properties of Eight-Item Physical Activity Enjoyment Scale in a Chinese Population. J Aging Phys Act. 2018 Oct 12:1-6. doi: 10.1123/japa.2017-0212. Online ahead of print.

    PubMed 29722637

  • Cheng S, Duan Y, Lau WB, Liang W, Chan NJ, Young KD, Baker JS, Lau TJ. Effect of a blended indoor and outdoor multicomponent structured exercise on depressive symptoms in Hong Kong older adults: study protocol of a randomized controlled trial. BMC Public Health. 2025 Nov 14;25(1):3949. doi: 10.1186/s12889-025-25244-0.

    PubMed 41239372

Questions about this trial

What is this clinical trial studying?

A study testing Blended indoor and outdoor multicomponent structured exercise and Indoor-only multicomponent structured exercise in people with Depressive Symptoms, run by Hong Kong Baptist University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanping Duan, P.hD (34115638, duanyp@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported depressive symptoms (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06190327, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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