An interventional study of Sport and Non-sport activities in Substance-related Disorders, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-12-11.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Prevention
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.
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:
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 28 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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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
Participants randomised to the exercise condition will receive 12 weeks of physical exercise training. Once they have been assigned to this group, they will be informed about the training programme and its content. Training will be carried out in groups (two groups of ten or four groups of five, depending on scheduling, sport preferences, available materials) to ensure that individual attention can be paid to each participant.
Other: Sport
The control group will not receive any exercise training. In order to control, as far as possible, for the potentially therapeutic effects of extra contact time with investigators, and the potentially motivational elements of participation in an intervention, the C group will have equal contact time with an investigator and participate in a leisure program without physical activity component. This time will be filled with group mealtimes, games, films, painting, handcrafts, stretching or relaxation exercises.
Other: Non-sport activities
Craving measured by the Brief Substance Craving Scale (translated)
Craving will be measured by the Brief Substance Craving Scale (translated)
Time frame: 6 months
Secondary substance consumption assessed using the Time Line Follow Back method
This will be assessed using the Time Line Follow Back method
Time frame: 6 months
Depression assessed using the Allgemeine Depressionskala ( Depression Scale)
Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale)
Time frame: 6 months
Self control measured using the Short Self Control Scale (translated)
This will be measured using the Short Self Control Scale (translated)
Time frame: 6 months
Subjective sleep measured using the Insomnia Severity Index (translated)
This will be measured using the Insomnia Severity Index (translated)
Time frame: 6 months
Physical activity level measured using the International Physical Activity Questionnaire
This will be measured using the International Physical Activity Questionnaire
Time frame: 6 months
Perceived Stress measured using the Perceived Stress Scale (translated)
Will be measured using the Perceived Stress Scale (translated)
Time frame: 6 months
Quality adjusted life years assessed using the Short Form (SF)36 questionnaire
This will be assessed using the Short Form (SF)36 questionnaire
Time frame: 6 months
Blood pressure measured using a digital sphygmomanometer
This will be measured using a digital sphygmomanometer
Time frame: 6 months
Lung function measured with a Spirobank Spirometer
Lung function will be measured with a Spirobank Spirometer
Time frame: 6 months
Hand grip strength assessed using a Hydraulic Hand Dynamometer.
This will be assessed using a Hydraulic Hand Dynamometer.
Time frame: 6 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland