Clinical trial NCT02309021: PHAST: Physical Activity in Substitution Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-related Disorders
Keywords: craving
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital of the University of Basel
First posted: 2014-12-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Craving measured by the Brief Substance Craving Scale (translated)
timeFrame: 6 months
measure: Secondary substance consumption assessed using the Time Line Follow Back method
timeFrame: 6 months
Secondary outcomes:
measure: Depression assessed using the Allgemeine Depressionskala ( Depression Scale)
timeFrame: 6 months
measure: Self control measured using the Short Self Control Scale (translated)
timeFrame: 6 months
measure: Subjective sleep measured using the Insomnia Severity Index (translated)
timeFrame: 6 months
measure: Physical activity level measured using the International Physical Activity Questionnaire
timeFrame: 6 months
measure: Perceived Stress measured using the Perceived Stress Scale (translated)
timeFrame: 6 months
measure: Quality adjusted life years assessed using the Short Form (SF)36 questionnaire
timeFrame: 6 months
measure: Blood pressure measured using a digital sphygmomanometer
timeFrame: 6 months
measure: Lung function measured with a Spirobank Spirometer
timeFrame: 6 months
measure: Hand grip strength assessed using a Hydraulic Hand Dynamometer.
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department for Sport, Exercise and Health
Study officials:
affiliation: Department for Sport, Exercise and Health
name: Flora Colledge, PhD
role: PRINCIPAL_INVESTIGATOR
References: