PHAST: Physical Activity in Substitution Therapy

Not Applicable

Completed

• Conditions: Substance-related Disorders
• Interventions: Other: Non-sport activities; Other: Sport

• Registration Number: NCT02309021
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Non-sport activities	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.
Sport Group	Sport	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Depression assessed using the Allgemeine Depressionskala ( Depression Scale)	6 months	Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale)
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)
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
Subjective sleep measured using the Insomnia Severity Index (translated)	6 months	This will be measured using the Insomnia Severity Index (translated)
Self control measured using the Short Self Control Scale (translated)	6 months	This will be measured using the Short Self Control Scale (translated)
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.

Trial Locations

Locations (1)

Department for Sport, Exercise and Health; 🇨🇭 Basel, Switzerland