Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits
NCT01171677, Not applicable, Completed, NYU Langone Health; results first posted 2013-03-06
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Exercise and Affirmations (IntenSati) on Addiction-related Cognitive and Psychosocial Deficits | ClinicalTrials.gov |
| NCT number | NCT01171677 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, actual | ClinicalTrials.gov |
| Lead sponsor | NYU Langone Health | ClinicalTrials.gov |
| Conditions | Drug Dependence, Alcohol Dependence | ClinicalTrials.gov |
| Interventions | IntenSati | ClinicalTrials.gov |
| First posted | 2010-07-28 | ClinicalTrials.gov |
| Last updated | 2013-03-06 | ClinicalTrials.gov |
| Results first posted | 2013-03-06 | ClinicalTrials.gov |
| Limitations and caveats | Overall small sample size, limited exercise intensity and capacity, missed exercise classes, dropout because of placement, work schedules and non-study-related medical conditions. | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hopkins Verbal Learning Test (HVLT) Total Recall | Baseline to end of intervention (week 14) | The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning. | ClinicalTrials.gov |
| Primary | Hopkins Verbal Learning Test (HVLT) Delayed Recall | Baseline to end of intervention (week 14) | Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention. | ClinicalTrials.gov |
| Primary | Hopkins Verbal Learning Test (HVLT) Delayed Recognition | Baseline to end of intervention (week 14) | Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability. | ClinicalTrials.gov |
| Primary | Stroop Word | Baseline to end of intervention (week 14) | Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility. | ClinicalTrials.gov |
| Primary | Stroop Color | Baseline to end of intervention (week 14) | Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility. | ClinicalTrials.gov |
| Primary | Stroop Color/Word | Baseline to end of intervention (week 14) | Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference. | ClinicalTrials.gov |
| Primary | Trailmaking Test A | Baseline to end of intervention (week 14) | Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed. | ClinicalTrials.gov |
| Primary | Trailmaking Test B | Baseline to end of intervention (week 14) | Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set. | ClinicalTrials.gov |
| Primary | Digit Span | Baseline to end of intervention (week 14) | Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory. | ClinicalTrials.gov |
| Primary | Controlled Oral Word Association Test (COWAT) | Baseline to end of intervention (week 14) | Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency. | ClinicalTrials.gov |
| Primary | Wechsler Test of Adult Reading (WTAR) | Baseline to end of intervention (week 14) | Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability. | ClinicalTrials.gov |
| Primary | Self-Efficacy for Abstinence | Baseline to end of intervention (week 14) | The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)'s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence. | ClinicalTrials.gov |
| Primary | Quality of Life (QoL) | Baseline to end of intervention (week 14) | The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction. | ClinicalTrials.gov |
| Primary | Roesenberg Self Esteem | Baseline to end of intervention (week 14) | The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem. | ClinicalTrials.gov |
Outcomes 14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Hopkins Verbal Learning Test (HVLT) Total Recall | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Hopkins Verbal Learning Test (HVLT) Delayed Recall | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Hopkins Verbal Learning Test (HVLT) Delayed Recognition | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Word | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Color | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Color/Word | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Trailmaking Test A | Baseline to end of intervention (week 14) | participants completing trial | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Trailmaking Test B | Baseline to end of intervention (week 14) | participants completing each arm | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Digit Span | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Controlled Oral Word Association Test (COWAT) | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Wechsler Test of Adult Reading (WTAR) | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Self-Efficacy for Abstinence | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Quality of Life (QoL) | Baseline to end of intervention (week 14) | participants completing intervention | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Roesenberg Self Esteem | Baseline to end of intervention (week 14) | participants completing each arm | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Hopkins Verbal Learning Test (HVLT) Total Recall | IntenSati | HVLT Total (baseline) | 17.27 | Standard Deviation 3.80 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Total Recall | Treatment as Usual | HVLT Total (baseline) | 18.00 | Standard Deviation 5.15 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Total Recall | IntenSati | HVLT Total (end of intervention) | 15.27 | Standard Deviation 3.98 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Total Recall | Treatment as Usual | HVLT Total (end of intervention) | 17.50 | Standard Deviation 3.50 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recall | IntenSati | HVLT Delayed (baseline) | 2.82 | Standard Deviation 1.72 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recall | Treatment as Usual | HVLT Delayed (baseline) | 5.00 | Standard Deviation 2.41 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recall | IntenSati | HVLT Delayed (end of intervention) | 3.91 | Standard Deviation 1.76 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recall | Treatment as Usual | HVLT Delayed (end of intervention) | 3.92 | Standard Deviation 2.94 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recognition | IntenSati | HVLT Delayed Recognition (baseline) | 18.55 | Standard Deviation 1.29 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recognition | Treatment as Usual | HVLT Delayed Recognition (baseline) | 21.33 | Standard Deviation 3.37 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recognition | IntenSati | HVLT Delayed Recognition (end of intervention) | 20.27 | Standard Deviation 1.62 | units on a scale | ClinicalTrials.gov |
| Hopkins Verbal Learning Test (HVLT) Delayed Recognition | Treatment as Usual | HVLT Delayed Recognition (end of intervention) | 22.33 | Standard Deviation 2.43 | units on a scale | ClinicalTrials.gov |
| Stroop Word | IntenSati | Stroop Word (baseline) | 77.36 | Standard Deviation 18.48 | units on a scale | ClinicalTrials.gov |
| Stroop Word | Treatment as Usual | Stroop Word (baseline) | 80.67 | Standard Deviation 20.15 | units on a scale | ClinicalTrials.gov |
| Stroop Word | IntenSati | Stroop Word (end of intervention) | 83.18 | Standard Deviation 14.66 | units on a scale | ClinicalTrials.gov |
| Stroop Word | Treatment as Usual | Stroop Word (end of intervention) | 79.25 | Standard Deviation 20.21 | units on a scale | ClinicalTrials.gov |
| Stroop Color | IntenSati | Stroop Color (baseline) | 54.27 | Standard Deviation 14.19 | units on a scale | ClinicalTrials.gov |
| Stroop Color | Treatment as Usual | Stroop Color (baseline) | 64.33 | Standard Deviation 16.55 | units on a scale | ClinicalTrials.gov |
| Stroop Color | IntenSati | Stroop Color (end of intervention) | 58.18 | Standard Deviation 14.74 | units on a scale | ClinicalTrials.gov |
| Stroop Color | Treatment as Usual | Stroop Color (end of intervention) | 65.67 | Standard Deviation 15.51 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | IntenSati | 17 | ClinicalTrials.gov | |
| Overall Study | STARTED | Treatment as Usual | 15 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | IntenSati | 11 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Treatment as Usual | 12 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | IntenSati | 6 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Treatment as Usual | 3 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | dizziness (R42) and dyspnoea (R06.0) | Cardiac disorders | Intensati | 1 | 17 | 1 | ClinicalTrials.gov |
| other | dizziness (R42) and dyspnoea (R06.0) | Cardiac disorders | Treatment As Usual | 0 | 15 | 0 | ClinicalTrials.gov |
| serious | Viral intestinal infection, unspecified (A08.4) | Gastrointestinal disorders | Intensati | 0 | 17 | 0 | ClinicalTrials.gov |
| serious | Viral intestinal infection, unspecified (A08.4) | Gastrointestinal disorders | Treatment As Usual | 1 | 15 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Intensati | ClinicalTrials.gov | ||
| Total, all-cause mortality | Treatment As Usual | ClinicalTrials.gov | ||
| Total, other adverse events | Intensati | 1 | 17 | ClinicalTrials.gov |
| Total, other adverse events | Treatment As Usual | 0 | 15 | ClinicalTrials.gov |
| Total, serious adverse events | Intensati | 0 | 17 | ClinicalTrials.gov |
| Total, serious adverse events | Treatment As Usual | 1 | 15 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intensati vs Treatment As Usual: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)