Trial · NCT06603727
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in subjective everyday life cognition after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Subjective executive function is measured by the Working Memory Questionnaire (WMQ), a 30-item, self-administered scale (score range from 0 to 120), addressing working memory (10 items), attention (10 items) and general executive function (10 items). The higher the score, the more it reflects cognitive difficulties. |
| Primary | Change in speed of information processing after a 6 weeks period of gamified cognitive and physical training | 6 weeks | Measured by the Symbol Digit Modalities Test (SDMT), scored from 0 to 110. The lower the score, the more it reflects cognitive difficulties. |
| Primary | Change in cognitive flexibility after a 6 weeks period of cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured by the time completion of the Color Trails Test (CTT) in CTT1 and CTT2 (i.e., Flexibility Index: (CTT2-CTT1)/CTT1). The higher the Flexibility Index, the more it reflects cognitive difficulties. |
| Primary | Change in visuospatial short-term memory after a 6 weeks period of cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), scored from 0 to 36. The lower the score, the more it reflects cognitive difficulties. |
| Secondary | Change in sustained attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured with the Test of Variables of Attention (TOVA) using the reaction time (RT) and the false alarm rate (FA). The higher the RT and FA, the more they reflect cognitive difficulties. |
| Secondary | Change in cognitive interference after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured with the Denis-Kaplan Color-Word interference Stroop test using the time completion in each condition. The higher the time completion, the more it reflects cognitive difficulties. |
| Secondary | Change in design fluency after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | The Five-Point Test will be used to assess design fluency using the total number of design produced. The lower the score, the more it reflects cognitive difficulties. |
| Secondary | Change in cognitive flexibility after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | A subtest of a custom-made tablet-based cognitive evaluation tool will measure cognitive flexibility. |
| Secondary | Change in visuo-spatial and verbal working memory control after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured using the Digit and Visuo-Spatial Span Test |
| Secondary | Change in divided attention after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Measured using the Test of Attentional Performance subtest Divided Attention |
| Secondary | Change in body composition (body fat and muscle mass) after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Body composition will be measured by bioelectrical impedance measure using the percentage of body fat and muscle mass. |
| Secondary | Change in risk of falls after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Risk of falls will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481). |
| Secondary | Change in limits of postural stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Limits of postural will be assessed using the BTrackS Balance Plate (FDA registered class 1 medical device #3010668481). |
| Secondary | Change in dynamic stability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Dynamic stability will be assessed by the Four Square Step Test, which tests the participant's ability to step over objects forwards, sideways and backwards; the movements of the FSST are comparable to the ones implemented in the training program. The score is based on time taken to complete the test. The higher the score, the more it reflects balance difficulties. |
| Secondary | Change in ability to perform a cognitive and physical dual task after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | In order to assess cognitive and motor dual task ability, the study participant will perform the Timed Up and Go Cognitive. The score is based on time taken to complete the test and errors or hesitations. The higher the score, the more it reflects cognitive difficulties. |
| Secondary | Change in heart rate variability after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Heart rate and heart rate variability will be recorded at rest in supine position during a 5-minute window using a medical electrocardiogramm (ECG). |
| Secondary | Change in systolic and diastolic blood pressure after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Determined by the mean of three blood pressure measurements using a sphygmomanometer and a stethoscope. |
| Secondary | Change in anxiety after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI; 20 items) in French, scored from 20 to 80. The higher the score, the higher the level of anxiety. |
| Secondary | Change in mood after a 6 weeks period of gamified cognitive and physical training (program 1 vs program 2) | 6 weeks | Mood will be assessed using the Center for Epidemiologic Studies - Depression (CES-D; 20 items) in French, scored from 0 to 60. The higher the score, the higher the level of depression. |
| Secondary | Change in everyday life activity / quality of life after a 6 weeks period of gamified cognitive and physical training | 6 weeks | Specifically developped for patients with an HIV infection, the Medical Outcomes Study HIV Health Survey (MOS-HIV; 35 items) will be used to assess everyday life activities and health-related quality of life. The score ranges from 0 to 100. The lower the score, the poorer the quality of life. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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