Exercise programmes during compulsory substance use rehabilitation in men: a 6-month study of muscle mass, bone status, body fat, and heart rate variability
| ISRCTN | ISRCTN58623135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58623135 |
| Ethics approval number | HYFW2025G02 |
| Sponsor | Zhejiang Police Vocational College |
| Funder | 2026 Soft Science Research Program of Zhejiang Province (No. 2026C35082) |
- Submission date
- 27/04/2026
- Registration date
- 05/05/2026
- Last edited
- 05/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Substance use disorders can affect physical health as well as mental and social functioning. People undergoing rehabilitation may have reduced muscle mass, higher body fat, poorer bone health, and changes in heart rate variability, which is an indicator of autonomic nervous system function. Exercise is often used in rehabilitation settings, but it is still unclear whether different types of exercise are associated with different patterns of physical recovery. The aim of this study is to compare four routine exercise programme pathways in men undergoing compulsory substance use rehabilitation in China and to examine how these programmes are associated with changes in muscle mass, body fat, bone status, and heart rate variability over time.
Who can participate?
Men aged 18 to 60 years with a diagnosis of substance use disorder who are undergoing compulsory substance use rehabilitation in the study facility can participate if they are medically cleared for exercise and have been resident in the facility for at least 90 days before the baseline assessment.
What does the study involve?
Participants are assigned through routine institutional scheduling, not by investigator-driven random allocation, to one of four programme pathways: usual care control, rehabilitation exercise, aerobic running, or resistance equipment exercise. The study follows participants for 26 weeks. Physical assessments are carried out at baseline, 3 months, and 6 months for body composition and heart rate variability, while bone status is assessed at baseline and 6 months. The study compares how the different exercise programmes are associated with changes in these physiological measures over time.
What are the possible benefits and risks of participating?
Participants may benefit from taking part in supervised exercise programmes that could support physical rehabilitation. However, benefits cannot be guaranteed. Possible risks include exercise-related fatigue, muscle soreness, minor strain, or discomfort during physical assessment procedures. To reduce risk, participants are medically screened before participation, exercise is supervised by trained staff, and routine institutional safety procedures are followed.
Where is the study run from?
The study is run from a compulsory substance use rehabilitation facility in China, with academic oversight from Zhejiang Police Vocational College (China)
When is the study starting and how long is it expected to run for?
April 2025 to January 2026
Who is funding the study?
The study is supported by the 2026 Soft Science Research Program of Zhejiang Province (No. 2026C35082) (China)
Who is the main contact?
Dr Dongming Jia, jiadm5332@126.com
Contact information
Principal investigator, Scientific, Public
Department of Criminal Justice, Zhejiang Police Vocational College, Zhejiang Province
Hangzhou
310018
China
 ORCID ID |
0000-0001-7662-6788 |
|---|---|
| Phone | +86 (0)13282135332 |
| jiadm5332@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A single-centre, assessor-blinded, non-randomized prospective interventional cohort study comparing routine exercise modalities for multidomain physiological adaptation in men undergoing compulsory substance use rehabilitation |
| Study acronym | EMPA-SUD |
| Study objectives | 1. To evaluate the longitudinal associations of three structured exercise programmes – rehabilitation exercise, aerobic running, and resistance equipment exercise – relative to usual care control with skeletal muscle mass, percent body fat, calcaneal bone mineral density, and heart rate variability over 26 weeks in men undergoing compulsory substance use rehabilitation. 2. To compare programme-associated musculoskeletal and autonomic adaptation profiles across the four institutional routine pathways. 3. To conduct exploratory analyses examining whether early body-composition changes statistically mediate later changes in bone or autonomic outcomes. |
| Ethics approval(s) |
Approved 01/04/2026, Ethics Committee of Zhejiang Police Vocational College (Xiasha Street 618, Hangzhou, 310018, China; +86 (0)1373540579; xueshx@163.com), ref: HYFW2025G02 |
| Health condition(s) or problem(s) studied | Substance use disorder (primarily methamphetamine, heroin, or other illicit substance use disorder) in men undergoing compulsory substance use rehabilitation |
| Intervention | Participants were assigned through routine institutional administrative scheduling based on residential-unit timetables and equipment capacity, rather than investigator-driven random allocation, to one of four parallel programme pathways. The usual care control group continued routine institutional activities, including approximately 20 minutes per day of morning calisthenics and occupational activities, without additional structured exercise. The rehabilitation exercise group received group-based rehabilitation calisthenics 5 days per week, 45 minutes per session, at light intensity (35%–50% of maximum heart rate). The running programme group received structured aerobic running 5 days per week, 40 minutes per session, at moderate intensity (60%–75% of maximum heart rate), with pace adjusted monthly using submaximal step-test calibration. The equipment exercise group received progressive resistance training 4 days per week, 50 minutes per session, involving 6 to 8 exercises at 65%–80% of one-repetition maximum, performed in 3 sets of 8 to 12 repetitions, with one-repetition maximum reassessed at weeks 4, 10, and 18. Participants were followed for 26 weeks. Outcome assessors and data analysts were blinded to programme group labels. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 18/01/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Male |
| Target sample size at registration | 148 |
| Total final enrolment | 148 |
| Key inclusion criteria | 1. Male sex 2. Aged 18 to 60 years 3. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of substance use disorder, primarily involving methamphetamine, heroin, or other illicit substances 4. Resident in the compulsory rehabilitation facility for at least 90 days before baseline assessment 5. Medically cleared for participation in exercise programmes |
| Key exclusion criteria | 1. Cardiovascular disease or uncontrolled hypertension 2. Musculoskeletal injury precluding exercise participation 3. Use of medications affecting bone metabolism within the preceding 6 months 4. Participation in structured exercise within the preceding 90 days |
| Date of first enrolment | 25/04/2025 |
| Date of final enrolment | 16/07/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
05/05/2026: Study's existence confirmed by the Ethics Committee of Zhejiang Police Vocational College.
