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Completed

NCT Number: NCT02309021

PHAST: Physical Activity in Substitution Therapy

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Sport, Exercise and Health

Basel, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sport

Other

Non-sport activities

Other

Primary outcomes

  1. Craving measured by the Brief Substance Craving Scale (translated)

    Time frame: 6 months

    Craving will be measured by the Brief Substance Craving Scale (translated)

  2. Secondary substance consumption assessed using the Time Line Follow Back method

    Time frame: 6 months

    This will be assessed using the Time Line Follow Back method

Secondary outcomes

  1. Depression assessed using the Allgemeine Depressionskala ( Depression Scale)

    Time frame: 6 months

    Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale)

  2. Self control measured using the Short Self Control Scale (translated)

    Time frame: 6 months

    This will be measured using the Short Self Control Scale (translated)

  3. Subjective sleep measured using the Insomnia Severity Index (translated)

    Time frame: 6 months

    This will be measured using the Insomnia Severity Index (translated)

  4. Physical activity level measured using the International Physical Activity Questionnaire

    Time frame: 6 months

    This will be measured using the International Physical Activity Questionnaire

  5. Perceived Stress measured using the Perceived Stress Scale (translated)

    Time frame: 6 months

    Will be measured using the Perceived Stress Scale (translated)

  6. Quality adjusted life years assessed using the Short Form (SF)36 questionnaire

    Time frame: 6 months

    This will be assessed using the Short Form (SF)36 questionnaire

  7. Blood pressure measured using a digital sphygmomanometer

    Time frame: 6 months

    This will be measured using a digital sphygmomanometer

  8. Lung function measured with a Spirobank Spirometer

    Time frame: 6 months

    Lung function will be measured with a Spirobank Spirometer

  9. Hand grip strength assessed using a Hydraulic Hand Dynamometer.

    Time frame: 6 months

    This will be assessed using a Hydraulic Hand Dynamometer.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Psychiatric Hospital of the University of Basel

Registry information

Official study 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

Acronym: PHAST

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2014
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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