Exercise for stress relief in adolescents with attention deficit hyperactivity disorder
| ISRCTN | ISRCTN14666639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14666639 |
| Secondary identifying numbers | Research Grants Council of Hong Kong (#14619720) |
- Submission date
- 14/07/2025
- Registration date
- 18/07/2025
- Last edited
- 18/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many young people with attention deficit/hyperactivity disorder (ADHD) struggle with stress, anxiety and other mental health problems. Medicines can help but often cause side effects, so families and doctors are looking for safe, non-drug alternatives. This study wants to find out whether a short, fun and mentally stimulating exercise programme can lower feelings of stress and improve stress-related biomarker (cortisol) in adolescents who have ADHD.
Who can participate?
Young people aged 12 – 17 years who are clinically diagnosed with ADHD (with or without autism comorbidity) and have an IQ of 70 or above
What does the study involve?
• Volunteers are randomly placed into either an exercise group or a control group (no new exercise).
• Exercise programme:
Runs for 3 weeks
2 sessions a week, each lasting 90 minutes
Activities include circuit training (planks, squats, reaction light drills) and game-based exercises such as “Bingo Fitness” and “Tic Tac Toe Fitness”.
Sessions are kept at a moderate to vigorous level (monitored with heart rate straps) and led by a qualified instructor experienced in working with ADHD.
• Measurements:
Saliva samples taken (to measure cortisol) at the start, straight after the programme and again three months later.
Short questionnaires on stress, anxiety and depression filled in at the same three timepoints.
What are the possible benefits and risks of participating?
Benefits
Taking part in a structured, enjoyable exercise programme may reduce stress and improve overall well-being.
Helping researchers design better, drug-free treatments for other adolescents with ADHD.
Risks/inconveniences
Temporary muscle soreness, tiredness linked to physical activity.
Mild discomfort from providing saliva samples.
Travel time to the university gym.
All sessions are supervised and safety checks (warm up, cool down, heart rate monitoring) are in place to keep risks low.
Where is the study run from?
Chinese University of Hong Kong (CUHK) gymnasium, Hong Kong SAR, China.
When is the study starting and how long is it expected to run for?
August 2022 to September 2023
Who is funding the study?
This study was funded by the General Research Fund (GRF) from the Research Grants Council of Hong Kong and the United College Endowment Fund Research Grant.
Who is the main contact?
Sima Dastamooz, simadastmaooz@link.cuhk.edu.hk
Contact information
Principal Investigator
Kwok Sport building, Chinese University of Hong Kong
Shatin
999077
Hong Kong
 ORCID ID |
0000-0001-9992-7866 |
|---|---|
| Phone | +(852) 3943 4126 |
| sithp@cuhk.edu.hk |
Public, Scientific
Kwok Sport building, Chinese University of Hong Kong
Shatin
999077
Hong Kong
| ORCID ID |
0000-0002-4972-1234 |
|---|---|
| Phone | +852 3943 0695 |
| simadastamooz@link.cuhk.edu.hk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Efficacy of short-term physical exercise intervention on stress biomarkers and mental health in adolescents with ADHD: a randomized controlled trial |
| Study objectives | 1. To assess the effectiveness of a PE intervention on self-reported stress, depression, and anxiety in adolescents with ADHD. 2. To measure salivary cortisol levels as stress biomarkers in adolescents with ADHD. |
| Ethics approval(s) |
Approved 11/08/2022, Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, 999077, Hong Kong; +(852)35053935; crec@cuhk.edu.hk), ref: 2022.317 |
| Health condition(s) or problem(s) studied | Mental health in adolescents with ADHD |
| Intervention | Physical Exercise (PE) group – cognitively engaging physical exercise programme Enrolment and randomisation: After parents and participants consent and baseline measures (T₀), participants were randomised 1 : 1 to Physical Exercise or Control groups. Content: • Six 90 min sessions (total = 540 min) over 3 weeks (2 ×week) delivered in a university gym. • Circuit block (≈35 min): planks, curl-ups, squats, balance ball tasks, speed ladder and BlazePod reaction light drills. • Game-based block (≈35 min): “Bingo Fitness” and “Tic Tac Toe Fitness,” requiring strategy, sequencing and teamwork. • 10 min structured warm-up and 10 min cool down each session. • Dose/intensity: ≥50 % of each session at moderate to vigorous intensity (60 80 % HRmax) verified by Polar M430 monitors. • Providers & setting: Certified fitness instructor (ratio 1 : 10) assisted by research staff; venue was the Chinese University of Hong Kong gymnasium. • Follow up: Outcome assessments immediately post intervention (T₁) and 3 months later (T₂). • Adherence strategies: Attendance certificate and HK$150 sports equipment coupon. Control group: • Continued usual routines; asked not to engage in any new organised PE programme for three weeks. • Same outcome assessments at baseline(T₀), immediately after PE intervention (T₁), three months later (T₂). |
| Intervention type | Behavioural |
| Primary outcome measure | Salivary cortisol concentration measured with a high sensitivity Salimetrics® ELISA (µg/dL) at baseline (T₀), immediately post-intervention (T₁) and 3 months post-intervention (T₂) |
| Secondary outcome measures | The secondary outcome measures are assessed at T₀, T₁, and T₂: 1. Self-reported stress score measured with the Chinese version of the Depression Anxiety Stress Scale 21 (DASS 21) 2. Self-reported anxiety score measured with the Chinese version of the Depression Anxiety Stress Scale 21 (DASS 21) 3. Self-reported depression score measured with the Chinese version of the Depression Anxiety Stress Scale 21 (DASS 21) |
| Overall study start date | 11/08/2022 |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 98 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Clinically diagnosed with attention deficit hyperactivity disorder 2. With or without autism comorbidity 3. An IQ of 70 or above |
| Key exclusion criteria | Neurological and intellectual impairments |
| Date of first enrolment | 11/09/2022 |
| Date of final enrolment | 15/05/2023 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Hong Kong
999077
Hong Kong
Sponsor information
Research council
7/F., Shui On Centre, 6-8 Harbour Road, Wanchai
Shatin
999077
Hong Kong
| Phone | (852) 2524 3987 |
|---|---|
| rgc@ugc.edu.hk | |
| Website | https://www.ugc.edu.hk/eng/rgc/funding_opport/grf/ |
"ROR" |
https://ror.org/00djwmt25 |
Funders
Funder type
Research council
Private sector organisation / Universities (academic only)
- Alternative name(s)
- The University Grants Committee, 學教育資助委員會, UGC
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Principal Investigator, Prof. Cindy Sit (sithp@cuhk.edu.hk), with a valid reason. Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? All de identified participant-level data collected during the trial (age, sex, BMI, raw salivary cortisol values, DASS 21 item scores) plus the accompanying data dictionary. What other documents will be available? Study protocol, statistical analysis plan, informed consent form When will the data be available (start and end dates)? Beginning 9 months after publication of the primary results paper and ending 5 years thereafter. With whom? Researchers who submit a methodologically sound proposal that is approved by the Principal Investigator (Prof Cindy Sit). For what types of analyses? Any scientifically valid purpose that is compatible with the original ethics approval. By what mechanism will the data be made available? Interested investigators should email Prof Sit (sithp@cuhk.edu.hk). Once a proposal is approved, requestors must sign a data use agreement. No data will be placed in an open public repository. |
Editorial Notes
15/07/2025: Study's existence confirmed by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee.
