PHAST: Physical Activity in Substitution Therapy

Substance-related Disorders Clinical Trial

— PHAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309021
• Other study ID #: UHospitalSwitz
• Status: Completed
• Phase: N/A
• First received: November 27, 2014
• Last updated: December 10, 2015
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Substance-related Disorders

Intervention

Other:
• Sport

• Non-sport activities

Locations

Country	Name	City	State
Switzerland	Department for Sport, Exercise and Health	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving measured by the Brief Substance Craving Scale (translated)	Craving will be measured by the Brief Substance Craving Scale (translated)	6 months	No
Primary	Secondary substance consumption assessed using the Time Line Follow Back method	This will be assessed using the Time Line Follow Back method	6 months	No
Secondary	Depression assessed using the Allgemeine Depressionskala ( Depression Scale)	Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale)	6 months	No
Secondary	Self control measured using the Short Self Control Scale (translated)	This will be measured using the Short Self Control Scale (translated)	6 months	No
Secondary	Subjective sleep measured using the Insomnia Severity Index (translated)	This will be measured using the Insomnia Severity Index (translated)	6 months	No
Secondary	Physical activity level measured using the International Physical Activity Questionnaire	This will be measured using the International Physical Activity Questionnaire	6 months	No
Secondary	Perceived Stress measured using the Perceived Stress Scale (translated)	Will be measured using the Perceived Stress Scale (translated)	6 months	No
Secondary	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	No
Secondary	Blood pressure measured using a digital sphygmomanometer	This will be measured using a digital sphygmomanometer	6 months	No
Secondary	Lung function measured with a Spirobank Spirometer	Lung function will be measured with a Spirobank Spirometer	6 months	No
Secondary	Hand grip strength assessed using a Hydraulic Hand Dynamometer.	This will be assessed using a Hydraulic Hand Dynamometer.	6 months	No