Trial Outcomes & Findings for Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease (NCT NCT02708485)

NCT ID: NCT02708485

Last Updated: 2018-10-16

Results Overview

Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Control Group No intervention	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).
Overall Study STARTED	3	12
Overall Study COMPLETED	0	10
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Control Group No intervention	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).
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=3 Participants The Sedentary group received no active treatment.	Physical Exercise n=10 Participants 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).	Total n=13 Participants Total of all reporting groups
Age, Continuous	77 years STANDARD_DEVIATION 2 • n=3 Participants	73 years STANDARD_DEVIATION 4 • n=10 Participants	75 years STANDARD_DEVIATION 2 • n=13 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	6 Participants n=10 Participants	9 Participants n=13 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	4 Participants n=10 Participants	4 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Mini-Mental State Examination	26 points n=3 Participants	26 points n=10 Participants	26 points n=13 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3)

Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging

Outcome measures

Measure	Control The Sedentary group received no active treatment.	Physical Exercise n=10 Participants 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).
Brain Glucose Consumption Baseline	—	27.9 umol/100 g/min Standard Deviation 3.2
Brain Glucose Consumption 3-month	—	28.1 umol/100 g/min Standard Deviation 3.4

PRIMARY outcome

Timeframe: 3 months

Population: 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).

Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging

Outcome measures

Measure	Control The Sedentary group received no active treatment.	Physical Exercise n=10 Participants 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).
Brain Acetoacetate Consumption Baseline	—	0.24 umol/100 g/min Standard Deviation 0.12
Brain Acetoacetate Consumption 3-month	—	0.64 umol/100 g/min Standard Deviation 0.40

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Cunnane

USherbrooke

Phone: 1-819-780-2220

Email: Stephen.Cunnane@USherbrooke.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place