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

Primary Purpose

Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
HIIT
Baduanjin
Workshop
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Depressive symptoms, Older adults, High-intensity interval training, Baduanjin Qigong

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Severe chronic disease restricting high-intensity exercise Having cognition impairment regarded by specialists

Sites / Locations

  • Bliss District Elderly Community CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

High-intensity interval training (HIIT)

Moderate intensity continuous training (MICT)

Non-exercise control

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 8, 2023
Last Updated
August 29, 2023
Sponsor
Hong Kong Baptist University
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1. Study Identification

Unique Protocol Identification Number
NCT06014294
Brief Title
Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hong Kong Baptist University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Depressive symptoms, Older adults, High-intensity interval training, Baduanjin Qigong

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
HIIT program for 16 weeks with a frequency of 2 times per week.
Arm Title
Moderate intensity continuous training (MICT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-exercise control
Arm Type
Placebo Comparator
Arm Description
Participants will not receive any exercise training, but attending 32 recreation workshops.
Intervention Type
Behavioral
Intervention Name(s)
HIIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Workshop
Intervention Description
Participants in the non-exercise control group will receive a series of workshops related to daily recreation.
Primary Outcome Measure Information:
Title
Self-reported depressive symptoms
Description
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).
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).
Secondary Outcome Measure Information:
Title
Concentration of saliva cortisol
Description
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.
Time Frame
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).
Title
Physical fitness
Description
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.
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).
Title
Sleep quality
Description
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.
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).
Title
Perceived quality of life
Description
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.
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).
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
Participants will be monitored by Polar verity sensor during exercise and their heart rate will be monitored to ensure their safety and intensity adherence of exercise protocol.
Time Frame
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.
Title
Self-reported Rate of Perceived Exertion (RPE)
Description
Older adults will be asked about the self-reported Rate of Perceived Exertion (RPE Borg CR-10 category scale) after they complete the main exercise training in each session.
Time Frame
RPE will be asked at the end of main exercise at each exercise session during the 16-weeks intervention.
Title
Safety: adverse events
Description
All adverse events will be recorded as safety endpoints.
Time Frame
Adverse events will be asked at the end of each exercise session during the 16-weeks intervention program.
Title
Exercise acceptability
Description
Exercise acceptability will be assessed post-intervention using ten questionnaire items responding to a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, and strongly agree). The score on this scale ranges from 10 to 50, the higher score shows better acceptability to the exercise intervention.
Time Frame
Outcome evaluations will be conducted at the completion of 16-weeks intervention.
Title
Process evaluation of intervention program
Description
A process evaluation scale of the intervention process will be developed for this study based on the previous framework of process evaluation for the intervention study. This scale with 10 items using a 5-point (strongly unsatisfied, unsatisfied, neutral, satisfied, and strongly satisfied). The score on this scale ranges from 10 to 50, a higher score shows higher satisfaction with the intervention program.
Time Frame
Outcome evaluations will be conducted at the completion of 16-weeks intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 to 74 years at the start date of the project Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-11 (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 Exclusion Criteria: Severe chronic disease restricting high-intensity exercise Having cognition impairment regarded by specialists
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanping Duan
Phone
34115638
Email
duanyp@hkbu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanping Duan
Organizational Affiliation
Hong Kong Baptist Univeristy; Department of Sport, Physical Education and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bliss District Elderly Community Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18590603
Citation
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.
Results Reference
background
PubMed Identifier
30968781
Citation
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.
Results Reference
background
PubMed Identifier
32471415
Citation
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.
Results Reference
background
PubMed Identifier
29227709
Citation
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.
Results Reference
background
PubMed Identifier
31780128
Citation
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.
Results Reference
background
PubMed Identifier
34531186
Citation
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.
Results Reference
background
PubMed Identifier
31883740
Citation
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.
Results Reference
background
PubMed Identifier
15222814
Citation
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. Erratum In: Psychol Assess. 2006 Mar;18(1):48.
Results Reference
background
PubMed Identifier
16155782
Citation
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.
Results Reference
background
Citation
Rikli RE, Jones CJ. Senior fitness test manual. Human kinetics; 2013
Results Reference
background
PubMed Identifier
32214167
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
23311722
Citation
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.
Results Reference
background
Links:
URL
https://www.who.int/news-room/fact-sheets/detail/depression
Description
World Health Organization. Depression (2020).
URL
https://www.chp.gov.hk/files/pdf/ncd_watch_sep2012.pdf
Description
Non-Communicable Diseases Watch. (2012). Depression: Beyond Feeling Blue.

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

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