NCT06014294

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.

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 Mar 2023

Typical duration for not_applicable

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

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 1, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

August 8, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

Depressive symptomsOlder adultsHigh-intensity interval trainingBaduanjin Qigong

Outcome Measures

Primary Outcomes (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).

    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 (4)

  • Concentration of saliva cortisol

    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 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).

  • Sleep quality

    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).

  • Perceived quality of life

    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 (5)

  • Heart rate

    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.

  • 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.

  • Safety: adverse events

    Adverse events will be asked at the end of each exercise session during the 16-weeks intervention program.

  • +2 more other outcomes

Study Arms (3)

High-intensity interval training (HIIT)

EXPERIMENTAL

HIIT program for 16 weeks with a frequency of 2 times per week.

Behavioral: HIIT

Moderate intensity continuous training (MICT)

ACTIVE COMPARATOR

Baduanjin exercise as MICT will be applied with the same program duration and frequency as the HIIT group. The entire set of Baduanjin Qigong exercises in the current study includes 8 postures.

Behavioral: Baduanjin

Non-exercise control

PLACEBO COMPARATOR

Participants will not receive any exercise training, but attending 32 recreation workshops.

Behavioral: Workshop

Interventions

HIITBEHAVIORAL

Participants will receive a 16-week HIIT program, with 2 sessions per week. Each session will comprise three sections, including warm-up, main exercise and cool down. The time will be between 34 to 40 minutes with progression of training. Each HIIT section will include ten combined exercises with self-weight. For Weeks 1-2, the HIIT section will include 10 intervals of 30 seconds HIIT workout at corresponding intensity, separated by 9 intervals of 60 seconds of active recovery.

High-intensity interval training (HIIT)
BaduanjinBEHAVIORAL

As a typical MICT, Baduanjin Qigong will be performed. The instructor will provide group teaching with individual instructions on specific movements. The same training principles of individuality and progression used in the HIIT group will also be applied to Baduanjin Qigong group.

Moderate intensity continuous training (MICT)
WorkshopBEHAVIORAL

Participants in the non-exercise control group will receive a series of workshops related to daily recreation.

Non-exercise control

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 5-11 (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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bliss District Elderly Community Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (15)

  • Leung GT, de Jong Gierveld J, Lam LC. Validation of the Chinese translation of the 6-item De Jong Gierveld Loneliness Scale in elderly Chinese. Int Psychogeriatr. 2008 Dec;20(6):1262-72. doi: 10.1017/S1041610208007552. Epub 2008 Jul 1.

    PMID: 18590603BACKGROUND
  • 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
  • Liu F, Cui J, Liu X, Chen KW, Chen X, Li R. The effect of tai chi and Qigong exercise on depression and anxiety of individuals with substance use disorders: a systematic review and meta-analysis. BMC Complement Med Ther. 2020 May 29;20(1):161. doi: 10.1186/s12906-020-02967-8.

    PMID: 32471415BACKGROUND
  • Zou L, Pan Z, Yeung A, Talwar S, Wang C, Liu Y, Shu Y, Chen X, Thomas GA. A Review Study on the Beneficial Effects of Baduanjin. J Altern Complement Med. 2018 Apr;24(4):324-335. doi: 10.1089/acm.2017.0241. Epub 2017 Dec 11.

    PMID: 29227709BACKGROUND
  • Martland R, Mondelli V, Gaughran F, Stubbs B. Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. J Affect Disord. 2020 Feb 15;263:629-660. doi: 10.1016/j.jad.2019.11.039. Epub 2019 Nov 12.

    PMID: 31780128BACKGROUND
  • Martland R, Korman N, Firth J, Vancampfort D, Thompson T, Stubbs B. Can high-intensity interval training improve mental health outcomes in the general population and those with physical illnesses? A systematic review and meta-analysis. Br J Sports Med. 2022 Mar;56(5):279-291. doi: 10.1136/bjsports-2021-103984. Epub 2021 Sep 16.

    PMID: 34531186BACKGROUND
  • Korman N, Armour M, Chapman J, Rosenbaum S, Kisely S, Suetani S, Firth J, Siskind D. High Intensity Interval training (HIIT) for people with severe mental illness: A systematic review & meta-analysis of intervention studies- considering diverse approaches for mental and physical recovery. Psychiatry Res. 2020 Feb;284:112601. doi: 10.1016/j.psychres.2019.112601. Epub 2019 Nov 28.

    PMID: 31883740BACKGROUND
  • 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
  • Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.

    PMID: 16155782BACKGROUND
  • Rikli RE, Jones CJ. Senior fitness test manual. Human kinetics; 2013

    BACKGROUND
  • Chen HC, Hsu NW, Chou P. Subgrouping Poor Sleep Quality in Community-Dwelling Older Adults with Latent Class Analysis - The Yilan Study, Taiwan. Sci Rep. 2020 Mar 25;10(1):5432. doi: 10.1038/s41598-020-62374-4.

    PMID: 32214167BACKGROUND
  • Leung KF, Tay M, Cheng SS, Lin F. Hong Kong Chinese version World Health Organization quality of life measure-abbreviated version. Hong Kong: Hong Kong Hospital Authority. 1997 Dec.

    BACKGROUND
  • Chapman, J. J., Coombes, J. S., Brown, W. J., Khan, A., Chamoli, S., Pachana, N. A., & Burton, N. W. (2017). The feasibility and acceptability of high-intensity interval training for adults with mental illness: A pilot study. Mental Health and Physical Activity, 13, 40-48.

    BACKGROUND
  • Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.

    PMID: 23311722BACKGROUND
  • Duan Y, Wang Y, Liang W, Wong HS, Baker JS, Yang S. Feasibility and effects of high-intensity interval training in older adults with mild to moderate depressive symptoms: A pilot cluster-randomized controlled trial. J Exerc Sci Fit. 2025 Jul;23(3):246-251. doi: 10.1016/j.jesf.2025.05.004. Epub 2025 May 24.

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yanping Duan

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanping Duan

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: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 28, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 31, 2024

Last Updated

September 1, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations