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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02309021 |
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Date of registration:
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27/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PHAST: Physical Activity in Substitution Therapy
PHAST |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02309021 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Flora Colledge, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department for Sport, Exercise and Health |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Substance-related Disorders
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Intervention(s)
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Other: Sport
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Other: Non-sport activities
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Primary Outcome(s)
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Craving measured by the Brief Substance Craving Scale (translated)
[Time Frame: 6 months]
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Secondary substance consumption assessed using the Time Line Follow Back method
[Time Frame: 6 months]
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Secondary Outcome(s)
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Blood pressure measured using a digital sphygmomanometer
[Time Frame: 6 months]
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Perceived Stress measured using the Perceived Stress Scale (translated)
[Time Frame: 6 months]
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Depression assessed using the Allgemeine Depressionskala ( Depression Scale)
[Time Frame: 6 months]
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Hand grip strength assessed using a Hydraulic Hand Dynamometer.
[Time Frame: 6 months]
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Lung function measured with a Spirobank Spirometer
[Time Frame: 6 months]
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Physical activity level measured using the International Physical Activity Questionnaire
[Time Frame: 6 months]
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Self control measured using the Short Self Control Scale (translated)
[Time Frame: 6 months]
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Subjective sleep measured using the Insomnia Severity Index (translated)
[Time Frame: 6 months]
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Quality adjusted life years assessed using the Short Form (SF)36 questionnaire
[Time Frame: 6 months]
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Secondary ID(s)
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UHospitalSwitz
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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