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The aim of this study is to evaluate the effect of a 3-month walking program on brain energy metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients with mild AD are followed and compared over a 3-month period of time: Control (non-active) and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks) groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No intervention | |
| Physical exercise | Experimental | A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Other | A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Glucose Consumption | Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging | 3 months |
| Brain Acetoacetate Consumption | Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Paquet, MD | Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke | Principal Investigator |
| Stephen Cunnane, PhD | CDRV - CSSS-IUGS - CIUSSS de l'Estrie - CHUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) | Sherbrooke | Quebec | J1H4C4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | No intervention |
| FG001 | Physical Exercise | A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). Physical exercise: A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The Sedentary group received no active treatment. |
| BG001 | Physical Exercise | A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Glucose Consumption | Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging | Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3) | Posted | Mean | Standard Deviation | umol/100 g/min | 3 months |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | No intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Cunnane | USherbrooke | 1-819-780-2220 | 45670 | Stephen.Cunnane@USherbrooke.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2017 | Aug 29, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Mini-Mental State Examination | The Mini-Mental State Examination (MMSE) is a 30-point questionnaire to measure cognitive impairment. A total score ≥26/30 indicates a normal cognition. Scores below this can indicate mild (20-25 points) , moderate (10-20 points) or severe (≤9 points) cognitive impairment. | Mean | Full Range | points |
|
|
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| Primary | Brain Acetoacetate Consumption | Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging | Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3). Two participants in the Walking group decided to withdraw from the study prior to the commencement of the exercise program. There were no dropouts over the training period (N=10). | Posted | Mean | Standard Deviation | umol/100 g/min | 3 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Physical Exercise | A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). Physical exercise: A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |