PHAST: Physical Activity in Substitution Therapy (PHAST)

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

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.

Study Overview

• Status: Completed
• Conditions: Substance-related Disorders
• Intervention / Treatment: Other: Sport; Other: Non-sport activities

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4052
    • Department for Sport, Exercise and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sport Group; 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
Other: Control Group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Psychiatric Hospital of the University of Basel
• Investigators: Principal Investigator: Flora Colledge, PhD, Department for Sport, Exercise and Health

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: craving
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: UHospitalSwitz