Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05076747 |
| Other study ID # |
199269 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2018 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will investigate the impact of cardiovascular exercise on brain plasticity among
patients in sub-acute stages after stroke, and whether genotype modulates the response to
this intervention. Participants in the experimental group will perform cardiovascular
training for 8 weeks, three times/week in addition to standard therapy, while participants in
the control group will perform standard therapy only. Assessments will be performed at
baseline, four weeks, and 8 weeks after training.
Description:
Background: Research has shown that the adult human brain has an enormous plastic capacity to
adapt after injury. In people who have recently experienced a stroke, interventions that
promote brain plasticity in early stages after stroke can improve long-term recovery.
Cardiovascular exercise is a simple strategy to increase brain plasticity and promote neural
reorganization. However, there is no information about the effects of cardiovascular exercise
on brain plasticity in early phases of stroke, despite the importance of this initial period
for long-term recovery. Similarly, it is not known if, depending on their genetic profile,
some people will be more responsive than others to this type of exercise.
Objectives: To establish whether: 1) cardiovascular exercise improves brain plasticity during
the initial phases of post-stroke recovery; 2) carrying a specific form of the BDNF gene
modulates the response to cardiovascular exercise.
Design: 70 participants will perform either a progressive high-intensity cardiovascular
exercise program or low-intensity stretching and toning exercise program. Both groups will
undergo 8 weeks of training performed 3 times per week. Assessments will be performed at the
beginning, mid-point (4 weeks) and at the end of the training period (8 weeks).
Methodology: Assessments: 1) brain plasticity by measuring changes in brain excitability, a
marker of brain plasticity, with non-invasive brain stimulation; 2) BDNF levels by measuring
the blood concentration of this protein; 3) Genotype by identifying the subtype of BDNF gene
carried by each participant; 4) Cardiorespiratory fitness by assessing the performance during
a graded exercise test.
Statistical analysis: Differences between exercise and control groups on the primary endpoint
of all outcomes will be analyzed with linear mixed models. Besides baseline scores, sex, age,
and type of stroke (cortical or subcortical) will be included as covariates because they can
affect brain plasticity and BDNF response. T1 scores will also be included to increase the
efficiency of the model. The influence of genotype on changes in primary and secondary
outcomes in the exercise group will be inspected with the Freedman-Schatzkin test, a powerful
technique to identify mediators of change that can be used in small-scale exercise studies.
Expected outcomes: Cardiovascular exercise will promote positive changes in brain
excitability and will increase blood BDNF levels in individuals in the early phases of stroke
recovery. However, the individual response to this type of exercise in relation to brain
plasticity and BDNF levels will be influenced by the genotype of each participant.
Relevance: It is important to establish whether cardiovascular exercise enhances brain
reorganization early after stroke post-stroke and whether genetic factors may influence the
response to this intervention. This will provide clinicians with useful information which
will be essential to design more individualized exercise-based treatments to optimize
functional recovery in individuals with stroke.
Impact: The first weeks after a stroke are critical for functional recovery. After this
initial period, the rate of recovery slows down and functional improvements become much more
difficult to achieve. In Canada, health-care costs in the 6 months after stroke amount to
$2.8 billion/year. Finding cost-effective rehabilitation strategies to promote recovery
during the early phases post-stroke is essential to help patients return to an independent
living.
