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Exercise as a Treatment for Substance Use Disorders Protocol (STRIDE)

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ClinicalTrials.gov Identifier: NCT01141608
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stimulant Abuse and Dependence
Interventions Other: Vigorous Intensity High Dose Exercise
Other: Health Education Intervention
Enrollment 302
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vigorous Intensity High Dose Exercise Health Education Intervention
Hide Arm/Group Description

Usual Care Augmented with Vigorous Intensity High Dose Exercise

Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.

Health Education Intervention

Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.

Period Title: Overall Study
Started 152 150
Completed 152 150
Not Completed 0 0
Arm/Group Title Vigorous Intensity High Dose Exercise Health Education Intervention Total
Hide Arm/Group Description

Usual Care Augmented with Vigorous Intensity High Dose Exercise

Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.

Health Education Intervention

Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.

Total of all reporting groups
Overall Number of Baseline Participants 152 150 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
152
 100.0%
150
 100.0%
302
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 150 participants 302 participants
38.5  (10) 39.5  (11) 39  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
Female
63
  41.4%
58
  38.7%
121
  40.1%
Male
89
  58.6%
92
  61.3%
181
  59.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 152 participants 150 participants 302 participants
152
 100.0%
150
 100.0%
302
 100.0%
1.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week.
Time Frame single value calculated based on TLFB data during days 22-84
Hide Outcome Measure Data
Hide Analysis Population Description
Mean percent stimulant abstinence days based on Timeline Follow back and Eliminate Contradiction (ELCON) algorithm adjustment.
Arm/Group Title Vigorous Intensity High Dose Exercise Health Education Intervention
Hide Arm/Group Description:
Participants randomized to Exercise completed supervised exercise sessions 3 times per week during the 12-week acute phase. Exercise was prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% of maximal heart rate (HRmax).
Participants randomized to Health Education also completed 3 visits per week during the 12-week acute phase. Health Education consisted of one-on-one sessions in which information on health-related topics (e.g., cancer, heart disease, mental health) was distributed via didactics, websites, audio, video, and written materials.
Overall Number of Participants Analyzed 152 150
Mean (Standard Deviation)
Unit of Measure: Percentage of Days
Timeline Follow Back (TLFB) 90.8  (16.4) 91.6  (14.7)
ELCON algorithm 75.5  (27.4) 77.2  (25.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vigorous Intensity High Dose Exercise, Health Education Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Linear mixed effects model
Comments [Not Specified]
2.Secondary Outcome
Title Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Dropout From Substance Abuse Treatment
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)
Hide Description [Not Specified]
Time Frame 9 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)
Hide Description [Not Specified]
Time Frame 9 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vigorous Intensity High Dose Exercise Health Education Intervention
Hide Arm/Group Description

Usual Care Augmented with Vigorous Intensity High Dose Exercise

Vigorous Intensity High Dose Exercise: Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.

Health Education Intervention

Health Education Intervention: Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.

All-Cause Mortality
Vigorous Intensity High Dose Exercise Health Education Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vigorous Intensity High Dose Exercise Health Education Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/152 (12.50%)      21/150 (14.00%)    
Surgical and medical procedures     
Medical condition * 1  19/152 (12.50%)  26 21/150 (14.00%)  24
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vigorous Intensity High Dose Exercise Health Education Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/152 (51.97%)      28/150 (18.67%)    
Blood and lymphatic system disorders     
Febrile Neutropenia * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Cardiac disorders     
Arrythmia * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Ear and labyrinth disorders     
Hearing impaired * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain lower * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Gastric ulcer haemorrhage * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Inguinal hernia * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Nausea * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Pancreatitis * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
General disorders     
chest discomfort * 1  3/152 (1.97%)  3 0/150 (0.00%)  0
chest pain * 1  3/152 (1.97%)  3 1/150 (0.67%)  1
Fatigue * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Non-cardiac chest apin * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
oedema peripheral * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Infections and infestations     
Abcess * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Brochitis * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Cellulitis * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Diverticulus * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Gastroenteritis * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Gastroenteritis cryptosporidial * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Hepatitis C * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Influenza * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Kidney infection * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Pneumonia * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Tooth abcess * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Injury, poisoning and procedural complications     
Accidental overdose * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Concussion * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Craniocerebral injury * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Hand fracture * 1  1/152 (0.66%)  1 1/150 (0.67%)  1
Heat exhaustion * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Heat Stroke * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Laceration * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Ligament rupture * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Ligament Sprain * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Muscle strain * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Post lumbar puncture syndrome * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Road Traffic accident * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Subdural haematoma * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Toxicity to various agents * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Wrist fracture * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Investigations     
Blood iron decreased * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Blood pressure abnormal * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Blood pressure diastolic decreased * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Blood pressure diastolic increased * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  17/152 (11.18%)  17 1/150 (0.67%)  1
Back pain * 1  10/152 (6.58%)  10 0/150 (0.00%)  0
Joint crepitation * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Joint swelling * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Medial tibial stress syndrome * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Muscle spasms * 1  8/152 (5.26%)  8 0/150 (0.00%)  0
Muscle tightness * 1  3/152 (1.97%)  3 0/150 (0.00%)  0
Musculo skeleton pain * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Myalgia * 1  11/152 (7.24%)  11 0/150 (0.00%)  0
Pain in extremity * 1  13/152 (8.55%)  13 0/150 (0.00%)  0
Nervous system disorders     
Burning sensation * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Dizziness * 1  8/152 (5.26%)  8 0/150 (0.00%)  0
Headache * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Hypoaesthesia * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Intracranial aneurysm * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Migraine * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Paraesthesia * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Sciatica * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Alcohol abuse * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
depression * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
Depression suicidal * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Mental Status Changes * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Post Traumatic stress Disorder * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Suicidal Behavior * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Suicidal Ideation * 1  4/152 (2.63%)  4 3/150 (2.00%)  3
Suicide Attempt * 1  1/152 (0.66%)  1 3/150 (2.00%)  3
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  3/152 (1.97%)  3 0/150 (0.00%)  0
Dyspnoea * 1  2/152 (1.32%)  2 1/150 (0.67%)  1
Pulmonary Embolism * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Skin and subcutaneous tissue disorders     
Blister * 1  2/152 (1.32%)  2 0/150 (0.00%)  0
skin irritation * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Victim of homicide * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Social circumstances     
Victim of Crime * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
victim of sexual abuse * 1  1/152 (0.66%)  1 0/150 (0.00%)  0
Surgical and medical procedures     
Sinus Operation * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Vascular disorders     
Hypertension * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
Hypertensive crisis * 1  0/152 (0.00%)  0 1/150 (0.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Enrollment of less severe group and differential adherence rates in the treatment arms are limitations.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Madhukar H Trivedi
Organization: UT Southwestern Medical Center
Phone: 214-648-0188
EMail: madhukar.trivedi@utsouthwestern.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Madhukar H. Trivedi, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01141608     History of Changes
Other Study ID Numbers: 5U10DA020024-04S1 ( U.S. NIH Grant/Contract )
5U10DA020024-05 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2010
First Posted: June 10, 2010
Results First Submitted: April 27, 2018
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018