PHAST: Physical Activity in Substitution Therapy

Study Overview
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Brief Summary
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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
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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: To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST. 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. To compare the effects of the EX and control conditions on the above-mentioned outcome variables. To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables. 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.

Official Title
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PHAST: Influence of Exercise Training on Substance Use, Substance Craving, Quality of Life, Mental Health, Sleep, and Physical Health in Patients Suffering From Opiate Dependence While Under Substitution Therapy

Conditions
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Substance-related Disorders

Intervention / Treatment
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* Other: Sport
* Other: Non-sport activities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sport Group<br>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<br> <br> |
| Other: Control Group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving measured by the Brief Substance Craving Scale (translated) | Craving will be measured by the Brief Substance Craving Scale (translated) | 6 months | 
| Secondary substance consumption assessed using the Time Line Follow Back method | This will be assessed using the Time Line Follow Back method | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression assessed using the Allgemeine Depressionskala ( Depression Scale) | Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale) | 6 months | 
| Self control measured using the Short Self Control Scale (translated) | This will be measured using the Short Self Control Scale (translated) | 6 months | 
| Subjective sleep measured using the Insomnia Severity Index (translated) | This will be measured using the Insomnia Severity Index (translated) | 6 months | 
| Physical activity level measured using the International Physical Activity Questionnaire | This will be measured using the International Physical Activity Questionnaire | 6 months | 
| Perceived Stress measured using the Perceived Stress Scale (translated) | Will be measured using the Perceived Stress Scale (translated) | 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 | 6 months | 
| Blood pressure measured using a digital sphygmomanometer | This will be measured using a digital sphygmomanometer | 6 months | 
| Lung function measured with a Spirobank Spirometer | Lung function will be measured with a Spirobank Spirometer | 6 months | 
| Hand grip strength assessed using a Hydraulic Hand Dynamometer. | This will be assessed using a Hydraulic Hand Dynamometer. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craving