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PHAST: Physical Activity in Substitution Therapy

NCT ID: NCT02309021

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Substance-related Disorders

Keywords

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craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Sport

Intervention Type 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.

Group Type OTHER

Non-sport activities

Intervention Type OTHER

Interventions

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Sport

Intervention Type OTHER

Non-sport activities

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychiatric Hospital of the University of Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flora Colledge, PhD

Role: PRINCIPAL_INVESTIGATOR

Department for Sport, Exercise and Health

Locations

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Department for Sport, Exercise and Health

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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UHospitalSwitz

Identifier Type: -

Identifier Source: org_study_id