Substance-related Disorders
Conditions
Keywords
craving
Brief summary
The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. street heroin, cocaine, cannabis, alcohol, cigarettes) other than prescribed ST or other prescribed medications; substance craving; blood pressure; lung function; resting pulse; social interaction; self-control capacity; objective and subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are current substitution dose and psychiatric diagnoses.
Detailed description
The investigators aim is to carry out a randomized controlled trial comparing exercise training group and a control group of patients receiving substitution therapy (ST). The specific goals of the study are: 1. To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST. 2. To examine whether a 12-week exercise programme affects the mental health, subjective and objective sleep, quality of life, self-control capacity, substance craving, hair cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung function, resting pulse, and social interaction in patients receiving ST. 3. To compare the effects of the EX and control conditions on the above-mentioned outcome variables. 4. To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables. 5. To explore to what extent objective variables (cardiovascular fitness, pulse, blood pressure, lung function, cortisol, objective sleep-EEG-parameters) and subjective-psychological dimensions (subjective sleep, social interaction, symptoms of depression and anxiety, self-control, substance craving) are interrelated.
Interventions
OTHERSport
OTHERNon-sport activities
Sponsors
Psychiatric Hospital of the University of Basel
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patient at the Ambulanter Dienst Sucht or Janus clinics in Basel Town (BS); currently under substitution therapy
Exclusion criteria
Declared unfit to participate by clinic personnel due to physical disability or severe psychological disturbance or cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Craving measured by the Brief Substance Craving Scale (translated) | 6 months | Craving will be measured by the Brief Substance Craving Scale (translated) |
| Secondary substance consumption assessed using the Time Line Follow Back method | 6 months | This will be assessed using the Time Line Follow Back method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep measured using the Insomnia Severity Index (translated) | 6 months | This will be measured using the Insomnia Severity Index (translated) |
| Physical activity level measured using the International Physical Activity Questionnaire | 6 months | This will be measured using the International Physical Activity Questionnaire |
| Perceived Stress measured using the Perceived Stress Scale (translated) | 6 months | Will be measured using the Perceived Stress Scale (translated) |
| Depression assessed using the Allgemeine Depressionskala ( Depression Scale) | 6 months | Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale) |
| Blood pressure measured using a digital sphygmomanometer | 6 months | This will be measured using a digital sphygmomanometer |
| Lung function measured with a Spirobank Spirometer | 6 months | Lung function will be measured with a Spirobank Spirometer |
| Hand grip strength assessed using a Hydraulic Hand Dynamometer. | 6 months | This will be assessed using a Hydraulic Hand Dynamometer. |
| Quality adjusted life years assessed using the Short Form (SF)36 questionnaire | 6 months | This will be assessed using the Short Form (SF)36 questionnaire |
| Self control measured using the Short Self Control Scale (translated) | 6 months | This will be measured using the Short Self Control Scale (translated) |
Countries
Switzerland
Outcome results
None listed