NCT06190327

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

December 19, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

depressive symptomsolder adultsmulticomponent structured exerciseblended indoor and outdoor environmentindoor exerciseconnectedness to nature

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

  • 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.

    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)

  • Physical fitness

    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).

  • Loneliness

    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).

  • Physical activity enjoyment

    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).

  • Connectedness to nature

    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 (2)

  • Self-reported Rate of Perceived Exertion (RPE)

    RPE will be asked at the end of main exercise at each exercise session during the 16-weeks intervention.

  • Process evaluation of intervention program

    Outcome evaluations will be conducted at the completion of 16-weeks intervention.

Study Arms (3)

blended indoor and outdoor multicomponent structured exercise group

EXPERIMENTAL

Participants will receive a 16-week blended indoor and outdoor multicomponent structured exercise program, with 2 sessions per week (90 mins/session).

Behavioral: Blended indoor and outdoor multicomponent structured exercise

indoor-only multicomponent structured exercise group

ACTIVE COMPARATOR

Participants will receive a 16-week indoor-only multicomponent structured exercise program, with 2 sessions per week (90 mins/session).

Behavioral: Indoor-only multicomponent structured exercise

control group

NO INTERVENTION

The control group will not receive any intervention during the whole project.

Interventions

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.

blended indoor and outdoor multicomponent structured exercise group

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.

indoor-only multicomponent structured exercise group

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bliss District Elderly Community Centre

Kowloon Bay, Hong Kong

RECRUITING

Related Publications (14)

  • 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.

    PMID: 30968781BACKGROUND
  • 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.

    PMID: 29086588BACKGROUND
  • 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.

    PMID: 32947051BACKGROUND
  • 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.

    PMID: 20174982BACKGROUND
  • 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.

    PMID: 27494042BACKGROUND
  • 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.

    PMID: 30875938BACKGROUND
  • 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.

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 15222814BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29722637BACKGROUND
  • 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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yanping Duan, P.hD

    Hong Kong Baptist Univeristy; Department of Sport, Physical Education and Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Duan, P.hD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

April 1, 2023

Primary Completion

July 1, 2024

Study Completion

November 3, 2024

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations