SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.
Study Goal
The researchers aimed to determine whether combined aerobic exercise and progressive resistance training (RT) improves cognition more than a balance and toning control intervention in older adults with Mild Cognitive Impairment (MCI), and whether adding cognitive training and vitamin D enhances efficacy.
Results Summary
The study hypothesizes that combined aerobic and resistance training will outperform balance and toning in improving cognition in MCI patients, with potential synergistic benefits from cognitive training and vitamin D. Results are pending as the trial is ongoing.
Population
Older adults aged 60-85 with Mild Cognitive Impairment (MCI).
Effective Dosage
Not specified for resistance training; vitamin D supplementation at 3 × 10,000 IU/week.
Duration
6 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Physical exercise, cognitive training, and vitamin D | increase | cognitive function and mobility | older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI) | - | have the potential to enhance | #1 |
Aerobic and progressive resistance exercises | increase | cognitive performance | - | - | have benefits to | #2 |
combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) | increase | cognition | older adults with MCI | - | will have a better effect on | #3 |
adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention | increase | - | - | - | will have synergistic efficacy | #4 |
combined AE and RT | increase | cognition and mobility | older adults with MCI | - | assesses the potential synergic effect of | #5 |
dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) | neutral | - | Two-hundred participants with MCI aged 60 to 85 years old | - | - | #6 |
multimodal intervention | increase | cognitive performance and mobility outcomes | MCI | - | to improve | #7 |
These interventions | decrease | cognitive-mobility decline | older individuals with MCI | - | may contribute to new approaches to stabilize and reverse | #8 |
BACKGROUND: Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. METHODS: The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. DISCUSSION: The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. TRIAL REGISTRATION: Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .