PHAST: Physical Activity in Substitution Therapy

NCT02309021 | Completed

• 1 other identifier: UHospitalSwitz
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-related Disorders

Keywords

craving

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Depression assessed using the Allgemeine Depressionskala ( Depression Scale)

  6 months

• Self control measured using the Short Self Control Scale (translated)

  6 months

• Subjective sleep measured using the Insomnia Severity Index (translated)

  6 months

• Physical activity level measured using the International Physical Activity Questionnaire

  6 months

• Perceived Stress measured using the Perceived Stress Scale (translated)

  6 months

Study Arms (2)

Sport Group

OTHER

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

Control Group

OTHER

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

Interventions

Sport OTHER

Sport Group

Non-sport activities OTHER

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at the Ambulanter Dienst Sucht or Janus clinics in Basel Town (BS); currently under substitution therapy

You may not qualify if:

• Declared unfit to participate by clinic personnel due to physical disability or severe psychological disturbance or cognitive impairment

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Psychiatric Hospital of the University of Basel: collaborator

Study Sites (1)

Department for Sport, Exercise and Health

Basel, 4052, Switzerland

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Flora Colledge, PhD

  Department for Sport, Exercise and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CH (1)