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The purpose of this study is to evaluate if exercise added to usual treatment improves cocaine dependence treatment. The primary objective of this study is to investigate if exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if exercise can reduce negative mood states, improve quality of life and facilitate abstinence of cocaine.
This study is designed as two-groups, randomized controlled trial to evaluate the effectiveness of an 8-week exercise program added to usual treatment compared with a health education program in 20 cocaine dependent patients. These participants will be randomized to one of the following two groups: a) exercise group: supervised moderate-vigorous exercise in group based on strength and calisthenics exercises, b) control group: supervised health education in group. All participants must have DSM-IV diagnosis of cocaine dependence as the primary disorder and must be in treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks. |
|
| Health education | Active Comparator | Health education sessions. 50 minutes per session, 2 times per week, 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss) | weekly, up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mood states measured by Profile of Mood States (POMS) | weekly, up to 8 weeks | |
| Quality of life measured by 36-item Short-Form Survey (SF-36) | monthly, up to 2 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuria Siñol Llosa | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | 08025 | Spain |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Health education | Behavioral | Supervised groups 2 times per week during 8 weeks. |
|
| Change in Physical fitness (BMI, functional capacity and strength) |
| Change from Baseline Physical Fitness at 2 months |
| Percent days abstinent defined as the ratio between the number of negative cocaine urine test and the number of realised cocaine urine test | weekly, up to 8 weeks |
| Change in cocaine craving measured by means of visual analogue scale (VAS) | Change from Baseline Cocaine Craving at 2 months |