Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder
NCT06560749, Not applicable, Recruiting, Beny Lafer
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Physical Exercise for Cognitive Rehabilitation of Patients With Bipolar Affective Disorder | ClinicalTrials.gov |
| NCT number | NCT06560749 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 72 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beny Lafer | ClinicalTrials.gov |
| Conditions | Bipolar Disorder | ClinicalTrials.gov |
| Interventions | Physical Exercise | ClinicalTrials.gov |
| First posted | 2024-08-19 | ClinicalTrials.gov |
| Last updated | 2026-07-16 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline, Week 4, Week 8 and Follow-up (12 weeks) | Scale used to assess the presence and intensity of depressive symptoms. | ClinicalTrials.gov |
| Primary | Young Mania Rating Scale (YMRS) | Baseline, Week 4, Week 8 and Follow-up (12 weeks) | Scale used to assess the presence and intensity of manic symptoms. | ClinicalTrials.gov |
| Primary | Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) | Baseline only | Screening scale for the presence of cognitive deficits. Suggested cutoff point is 14 | ClinicalTrials.gov |
| Primary | Screen for Cognitive Impairment in Psychiatry (SCIP) | Baseline only | Subjective screening scale for difficulties associated with cognitive impairment. Suggested cutoff point is 70 | ClinicalTrials.gov |
| Primary | Stroop Color-Word Test (Spreen and Strauss, 1998) | Baseline and Follow-up (12 weeks) | Assessing mental flexibility and inhibitory control (attention and executive function) | ClinicalTrials.gov |
| Primary | Verbal Fluency - F.A.S (Spreen and Strauss, 1998) | Baseline and Follow-up (12 weeks) | Assessing verbal fluency, inhibitory control and the correct use of strategies (executive function) | ClinicalTrials.gov |
| Primary | Trail Making Test (Spreen and Strauss, 1998) | Baseline and Follow-up (12 weeks) | Assessing alternating attention | ClinicalTrials.gov |
| Primary | Logical Memory I and II (Wechsler, 1997b) | Baseline and Follow-up (12 weeks) | Assessing verbal memory | ClinicalTrials.gov |
| Primary | List of Words (Wechsler, 1997a) | Baseline and Follow-up (12 weeks) | Assessing learning capacity and attention | ClinicalTrials.gov |
| Primary | Cardiovascular evaluation | Baseline and Follow-up (12 weeks) | All patients will undergo an electrocardiogram computerized. | ClinicalTrials.gov |
| Primary | Stress test on the treadmill | Baseline and Follow-up (12 weeks) | A treadmill stress test will be performed. | ClinicalTrials.gov |
| Primary | Respiratory gas exchange analysis (ergospirometric) | Baseline and Follow-up (12 weeks) | A computerized gas exchange analysis system will be used (CPX/ULTIMA, Medgraphics®, Saint Paul, MN, USA) | ClinicalTrials.gov |
| Primary | Isokinetic Strength Test | Baseline and Follow-up (12 weeks) | The isokinetic test will be performed on the lower limbs (extensor and flexor muscles of the knee joints) on the dominant (R) and non-dominant (ND) leg at an angular velocity of 60 s -1 using a computerized isokinetic dynamometer (Biodex®, Inc . USA). | ClinicalTrials.gov |
| Primary | Body composition by bioimpedance | Baseline and Follow-up (12 weeks) | Body composition measurements will be obtained by the non-invasive indirect bioimpedance method using a scale | ClinicalTrials.gov |
| Primary | Anthropometric measurements (skinfolds) and calculation of body composition | Baseline and Follow-up (12 weeks) | Body mass (BM) will be measured on a Filizola mechanical scale, with an accuracy of 0.1 kg. Height will be determined using a stadiometer, attached to the scale, with an accuracy of 0.1cm (Gordon et al., 1988). Body composition will be determined using the skinfold thickness technique. | ClinicalTrials.gov |
| Primary | One Repetition Maximum Test (1RM) | Baseline and Follow-up (12 weeks) | The exercises to be tested are the seated bench press (pectoral muscles), leg-press (quadriceps and glutes), rowing (dorsal muscles), standing knee bending chair (hamstrings), abdominal (rectus and abdominal obliques). | ClinicalTrials.gov |
| Primary | Wechsler Abbreviated Scale of Intelligence (WASI) | Baseline and Follow-up (12 weeks) | delivers an estimation of a student's general intellectual ability by measuring the verbal, nonverbal, and general cognition of individuals from 6 to 89 years of age. | ClinicalTrials.gov |
| Primary | Digit Span Memory Test | Baseline and Follow-up (12 weeks) | short test that evaluates a person's memory and cognitive status | ClinicalTrials.gov |
| Primary | Cognitive Emotion Regulation Questionnaire (CERQ) | Baseline and Follow-up (12 weeks) | Questionnaire measuring cognitive coping strategies | ClinicalTrials.gov |
| Primary | Difficulties in Emotion Regulation Scale (DERS) | Baseline and Follow-up (12 weeks) | Instrument measuring emotion regulation problems | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
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 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
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 |
| Short Story Recall | 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 |
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)