Trial Outcomes & Findings for SYNchronizing Exercises, Remedies in GaIt and Cognition (NCT NCT02808676)
NCT ID: NCT02808676
Last Updated: 2025-02-21
Results Overview
Global cognition will be assessed using the cognitive section of the Alzheimer Disease Assessment Scale-plus EF+FA (ADAS-Cog-plus). This scale consists of 10 brief cognitive tests assessing memory, language, executive function, praxis, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD. The ADAS-Cog-plus has marked advantages as an outcome measure in MCI populations since incorporates items concerning executive function (EF) and functional abilities (FA). Scores in the ADASCog-plus (EF+FA) range from 0 to 90, with higher scores indicating better cognitive performance.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
baseline and at 20 weeks (after interventions finalised)
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
Exercises+CognitiveTraining+Vitamin D3
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
37
|
35
|
34
|
|
Overall Study
COMPLETED
|
31
|
28
|
31
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
6
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
Baseline characteristics by cohort
| Measure |
Exercises+CognitiveTraining+Vitamin D3
n=34 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
n=35 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
n=37 Participants
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
n=35 Participants
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
n=34 Participants
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age between 65 and 84 years
|
31 Participants
n=31 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
28 Participants
n=28 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
31 Participants
n=31 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
28 Participants
n=28 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
26 Participants
n=26 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
144 Participants
n=144 Participants • A total of 175 participants were initially randomized in the study, and baseline characteristics were obtained for all enrolled participants. However, 31 participants withdrew from the study before completing either the intervention or required follow-up assessments and thus were excluded from the final statistical analysis. Data from 144 participants were thus included in the primary statistical analysis.
|
|
Sex: Female, Male
Female
|
21 Participants
n=34 Participants
|
16 Participants
n=35 Participants
|
20 Participants
n=37 Participants
|
12 Participants
n=35 Participants
|
17 Participants
n=34 Participants
|
86 Participants
n=175 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=34 Participants
|
19 Participants
n=35 Participants
|
17 Participants
n=37 Participants
|
23 Participants
n=35 Participants
|
17 Participants
n=34 Participants
|
89 Participants
n=175 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
34 participants
n=34 Participants
|
35 participants
n=35 Participants
|
37 participants
n=37 Participants
|
35 participants
n=35 Participants
|
34 participants
n=34 Participants
|
175 participants
n=175 Participants
|
PRIMARY outcome
Timeframe: baseline and at 20 weeks (after interventions finalised)Global cognition will be assessed using the cognitive section of the Alzheimer Disease Assessment Scale-plus EF+FA (ADAS-Cog-plus). This scale consists of 10 brief cognitive tests assessing memory, language, executive function, praxis, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD. The ADAS-Cog-plus has marked advantages as an outcome measure in MCI populations since incorporates items concerning executive function (EF) and functional abilities (FA). Scores in the ADASCog-plus (EF+FA) range from 0 to 90, with higher scores indicating better cognitive performance.
Outcome measures
| Measure |
Exercises+CognitiveTraining+Vitamin D3
n=31 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
n=28 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
n=31 Participants
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
n=28 Participants
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
n=26 Participants
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
|---|---|---|---|---|---|
|
Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities).
|
-2.42 score on a scale
Standard Error 0.70
|
-2.14 score on a scale
Standard Error 0.73
|
-0.39 score on a scale
Standard Error 0.69
|
-1.34 score on a scale
Standard Error 0.73
|
0.24 score on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: baseline at 20 weeks (after interventions finalised)The Canadian Consortium on Neurodegeneration in Aging (CCNA) has established a battery of neuropsychological test which will used as secondary outcomes e.g., ADAS-Cog-13, which is scored from 0 to 70, with higher scores indicating greater cognitive impairment.
Outcome measures
| Measure |
Exercises+CognitiveTraining+Vitamin D3
n=34 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
n=35 Participants
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
n=37 Participants
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
n=35 Participants
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
n=34 Participants
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
|---|---|---|---|---|---|
|
Change in Cognition Assessed as the CCNA Cognitive Battery.
|
15.3 score on a scale (ADAS-Cog-13)
Standard Error 8
|
14.5 score on a scale (ADAS-Cog-13)
Standard Error 6.1
|
16.6 score on a scale (ADAS-Cog-13)
Standard Error 7.6
|
15.6 score on a scale (ADAS-Cog-13)
Standard Error 6.6
|
13.7 score on a scale (ADAS-Cog-13)
Standard Error 5.3
|
SECONDARY outcome
Timeframe: baseline at 20 weeks (after interventions finalised)Frequency and circumstances of falls over the study period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline at 20 weeks (after interventions finalised)Assessment of usual and fast-paced walking to evaluate mobility performance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline at 20 weeks (after interventions finalised)A higher CoV indicates greater variability, which has been associated with increased fall risk and impaired motor control, particularly in individuals with Mild Cognitive Impairment (MCI
Outcome measures
Outcome data not reported
Adverse Events
Exercises+CognitiveTraining+Vitamin D3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Exercises+CognitiveTraining+Placebo D3
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Exercises+Control CogTraining+Vitamin D3
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Exercises+Control CogTraining+Placebo D3
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Exercise+Control Cog+Placebo D3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercises+CognitiveTraining+Vitamin D3
n=34 participants at risk
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
n=35 participants at risk
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
n=37 participants at risk
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
n=35 participants at risk
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
n=34 participants at risk
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
|---|---|---|---|---|---|
|
Nervous system disorders
Minor Stroke
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/35 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/37 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/35 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/35 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.7%
1/37 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/35 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/35 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/37 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/35 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
Other adverse events
| Measure |
Exercises+CognitiveTraining+Vitamin D3
n=34 participants at risk
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
|
Exercises+CognitiveTraining+Placebo D3
n=35 participants at risk
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise.
Cognitive Training (CT): CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3: matching placebo for Vitamin D3
|
Exercises+Control CogTraining+Vitamin D3
n=37 participants at risk
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3: Dose: 10000 IU, three times per week, orally.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Exercises+Control CogTraining+Placebo D3
n=35 participants at risk
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E): All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
|
Placebo Exercise+Control Cog+Placebo D3
n=34 participants at risk
This will be the comparator arm with control/placebo activities.
placebo D3: matching placebo for Vitamin D3
control cognitive training: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise: As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.8%
4/34 • Number of events 4 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
14.3%
5/35 • Number of events 5 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
10.8%
4/37 • Number of events 4 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
22.9%
8/35 • Number of events 8 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
8.8%
3/34 • Number of events 3 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
Investigations
Fall (tripped or slipped)
|
2.9%
1/34 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/35 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.7%
1/37 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
5.7%
2/35 • Number of events 2 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
5.9%
2/34 • Number of events 2 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
General disorders
Numbness
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
5.7%
2/35 • Number of events 2 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.7%
1/37 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/35 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
General disorders
Dizziness
|
5.9%
2/34 • Number of events 2 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/35 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/37 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/35 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
0.00%
0/34 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
|
General disorders
Others
|
2.9%
1/34 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
11.4%
4/35 • Number of events 4 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
8.1%
3/37 • Number of events 3 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
5.7%
2/35 • Number of events 2 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
2.9%
1/34 • Number of events 1 • From baseline visit and up to 30 days after study participation has ended month 12 visit.
|
Additional Information
Dr. Manuel Montero-Odasso
Lawson Health Research Institute
Phone: 519-685-4292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place