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Depressive SymptomsNCT06014294

Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults

A study testing HIIT, Baduanjin and Workshop 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 The sponsor has not verified this record for over two years, so it may be out of date.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 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… 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?
HIIT, Baduanjin and Workshop
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
1 siteHong Kong
Study dates
1 Mar 2023to 31 Dec 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 5-11 (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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Yanping Duan contact

34115638

duanyp@hkbu.edu.hk

Hong Kong1 site, 1 recruiting
  • Bliss District Elderly Community Centre

    Hong Kong

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
HIIT, Baduanjin, Workshop
Keywords
Depressive symptoms, Older adults, High-intensity interval training, Baduanjin Qigong
Medical subject headings
Depression

What participants receive

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

  • HIITBehavioural

    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.

  • BaduanjinBehavioural

    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.

  • WorkshopBehavioural

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

Study groups in NCT06014294
Study groupRoleWhat they receive
High-intensity interval training (HIIT)ExperimentalHIIT program for 16 weeks with a frequency of 2 times per week.
Receives: Behavioral: HIIT
Moderate intensity continuous training (MICT)Active comparatorBaduanjin 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.
Receives: Behavioral: Baduanjin
Non-exercise controlPlacebo comparatorParticipants will not receive any exercise training, but attending 32 recreation workshops.
Receives: Behavioral: Workshop

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).

Secondary outcomes (4)
  1. 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).

  2. Physical fitness

    Physical fitness will be assessed using the Senior Fitness Test (SFT) battery. There are seven testing items measuring all five dimensions of PT, 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).

  3. Sleep quality

    The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure sleep quality. The PSQI is a widely validated scale appropriate for use with older adults. The scale includes 18 items, covering seven domains: subjective SQ, sleep latency, sleep duration, sleep efficiency, frequency of sleep disturbance, daytime dysfunction, and use of sleep medications.

    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).

  4. Perceived quality of life

    The quality of life will be assessed by the Hong Kong Chinese WHO Quality of Life Scale brief version (WHOQOL-BREF) (Cronbach's α = .73 -.84). The scale includes 28 items, covering four dimensions of how older adults perceive their quality of life.

    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).

Timeline

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

  1. First posted28 Aug 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion31 Dec 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
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014294
Sponsor's protocol ID
12616922
Status last verified
Jun 2023
First submitted
8 Aug 2023
Last updated
1 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18590603
  • 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
  • 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.

    PubMed 32471415
  • 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.

    PubMed 29227709
  • 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.

    PubMed 31780128
  • 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.

    PubMed 34531186
  • 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.

    PubMed 31883740
  • 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
  • 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.

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

  • 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.

    PubMed 32214167
  • 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.

  • 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.

  • 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.

    PubMed 23311722
  • Wang Y, Liang W, Duan Y, Lau WMB, Chan NMJ, Yang S, Baker JS. Effects of high-intensity interval training on depressive symptoms in Hong Kong community-dwelling older adults with mild to moderate depressive symptoms: a study protocol for a cluster randomized controlled trial. Front Public Health. 2026 Jan 27;14:1697763. doi: 10.3389/fpubh.2026.1697763. eCollection 2026.

    PubMed 41674520

Questions about this trial

What is this clinical trial studying?

A study testing HIIT, Baduanjin and Workshop 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 7 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 1 Sep 2023. 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. Some participants in this study may receive a placebo. 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 (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).). 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 NCT06014294, which also lists 16 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 1 Sep 2023.

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