Trial Outcomes & Findings for Exercise as a Treatment for Substance Use Disorders Protocol (NCT NCT01141608)
NCT ID: NCT01141608
Last Updated: 2020-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
single value calculated based on TLFB data during days 22-84
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
Vigorous Intensity High Dose Exercise
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
COMPLETED
|
152
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise as a Treatment for Substance Use Disorders Protocol
Baseline characteristics by cohort
| Measure |
Vigorous Intensity High Dose Exercise
n=152 Participants
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
n=150 Participants
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
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
152 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 11 • n=7 Participants
|
39 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: single value calculated based on TLFB data during days 22-84Population: Mean percent stimulant abstinence days based on Timeline Follow back and Eliminate Contradiction (ELCON) algorithm adjustment.
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.
Outcome measures
| Measure |
Vigorous Intensity High Dose Exercise
n=152 Participants
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).
|
Health Education Intervention
n=150 Participants
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.
|
|---|---|---|
|
Percent Days Abstinent
Timeline Follow Back (TLFB)
|
90.8 Percentage of Days
Standard Deviation 16.4
|
91.6 Percentage of Days
Standard Deviation 14.7
|
|
Percent Days Abstinent
ELCON algorithm
|
75.5 Percentage of Days
Standard Deviation 27.4
|
77.2 Percentage of Days
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
Outcome data not reported
Adverse Events
Vigorous Intensity High Dose Exercise
Serious events: 19 serious events
Other events: 79 other events
Deaths: 0 deaths
Health Education Intervention
Serious events: 21 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vigorous Intensity High Dose Exercise
n=152 participants at risk
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
n=150 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Medical condition
|
12.5%
19/152 • Number of events 26
|
14.0%
21/150 • Number of events 24
|
Other adverse events
| Measure |
Vigorous Intensity High Dose Exercise
n=152 participants at risk
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
n=150 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Cardiac disorders
Arrythmia
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Nausea
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Gastrointestinal disorders
Pancreatitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
General disorders
chest discomfort
|
2.0%
3/152 • Number of events 3
|
0.00%
0/150
|
|
General disorders
chest pain
|
2.0%
3/152 • Number of events 3
|
0.67%
1/150 • Number of events 1
|
|
General disorders
Fatigue
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
General disorders
Non-cardiac chest apin
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
General disorders
oedema peripheral
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Abcess
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Brochitis
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Diverticulus
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Gastroenteritis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Influenza
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Kidney infection
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Infections and infestations
Pneumonia
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Tooth abcess
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.66%
1/152 • Number of events 1
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Road Traffic accident
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Investigations
Blood iron decreased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Investigations
Blood pressure diastolic decreased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Investigations
Blood pressure diastolic increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
17/152 • Number of events 17
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
10/152 • Number of events 10
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
8/152 • Number of events 8
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.0%
3/152 • Number of events 3
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Musculo skeleton pain
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.2%
11/152 • Number of events 11
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
13/152 • Number of events 13
|
0.00%
0/150
|
|
Nervous system disorders
Burning sensation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Dizziness
|
5.3%
8/152 • Number of events 8
|
0.00%
0/150
|
|
Nervous system disorders
Headache
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Paraesthesia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Sciatica
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Psychiatric disorders
depression
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Psychiatric disorders
Post Traumatic stress Disorder
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Psychiatric disorders
Suicidal Behavior
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Psychiatric disorders
Suicidal Ideation
|
2.6%
4/152 • Number of events 4
|
2.0%
3/150 • Number of events 3
|
|
Psychiatric disorders
Suicide Attempt
|
0.66%
1/152 • Number of events 1
|
2.0%
3/150 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
3/152 • Number of events 3
|
0.00%
0/150
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/152 • Number of events 2
|
0.67%
1/150 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.3%
2/152 • Number of events 2
|
0.00%
0/150
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Social circumstances
Victim of Crime
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Skin and subcutaneous tissue disorders
Victim of homicide
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Social circumstances
victim of sexual abuse
|
0.66%
1/152 • Number of events 1
|
0.00%
0/150
|
|
Surgical and medical procedures
Sinus Operation
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/152
|
0.67%
1/150 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place