An interventional study of Aerobic and Resistance Exercise and Educational information about health topics in Addiction, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has an effect (good or bad) on the health and drug use of participants as compared to individuals not participating in an exercise program.
Participants were recruited to the study using various methods, including word of mouth and IRB-approved flyers posted throughout the treatment facility. Onsite study staff screened MA-dependent clients in a private study office and reviewed the informed consent protocol. After completion of informed consent procedures, participants entered a1-2week screening phase to determine eligibility, consisting of medical history, physical exam, laboratory studies, and ECG. Eligible clients were taken through study baseline assessments to inform randomization to study conditions, either an exercise intervention or health education control, using a computerized urn randomization program that stratified clients to conditions based on gender (male/female) and severity of baseline MA use (higher vs. lower severity). The cut-off point for determining lower severity MA use versus higher severity use was identified using data from previous clinical outcome studies that show the median number of days of MA use ranges from16 to 20 days at treatment entry. Hence, we defined "lower severity" as using MA for 18 or fewer days in the previous month, and "higher severity" as using for 19 or more days in the past month. The study's data management center (DMC) maintained the urn randomization program and the records that linked participant identification numbers to study condition. Study interventions were conducted onsite while participants were enrolled in usual care at the residential treatment facility; cases of early discharge from the facility resulted in premature termination from the study.
Participants randomized to the exercise condition received a structured exercise program 3 times a week for 8 weeks. Exercise sessions consisted of a 5-min warm-up, 30 min of aerobic activity on a treadmill, followed by 15 min of weight training and a 5-min cool-down/stretching period. Each session was monitored by a staff exercise physiologist who guided one to two participants at a time. Using heart rate monitors, the exercise physiologist worked closely with each individual participant on exercise days to increase treadmill speed/slope to maintain a heart rate between 60% and 85% of maximum for 30 minutes. Once a participant was able to complete two sets of 15 repetitions of any given exercise, weight was incrementally increased.
A data collection protocol occurred at baseline, and also weekly during the 8-week study period, at termination of the study period, and at 1-, 3-, and 6-months post treatment from the residential program (approximately 7-10 days following completion of the intervention period). Participants were compensated $40 per data collection session.
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This study's enrollment of 135 is above the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
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Exclusion Criteria:
Participants in this group will be scheduled for 24 exercise training sessions over an 8-week period (three times weekly) and will be supervised by a certified exercise physiologist.
Behavioral: Aerobic and Resistance Exercise
Participants in this group will meet with a counselor who will present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
Behavioral: Educational information about health topics
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
Self-reported Days of Methamphetamine Use
The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.
Time frame: over the 12 week follow-up period
Overall Physical Health
The effect of the interventions will be compared between the Exercise and Education groups using generalized regression for repeated measures on each of the test results from baseline to discharge to 12 weeks post-discharge
Time frame: 12-week follow-up period
Brain-Imaging Data
To examine pre- to post-intervention differences in D2/D3 receptor availability a repeated-measures ANOVA will be performed using the binding potential for \[18F\]fallypride in subcortical regions of interest.
Time frame: End of intervention (9 weeks)
Psychiatric Symptoms
The effect of the interventions will be compared with repeated measures analysis from baseline to discharge to 12 and 26 weeks after discharge.
Time frame: 12 week follow-up period
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles