Motor-assisted Cycling and FES Cycling for Postprandial Glucose in Diabetic Patients With ADL Disability
|ClinicalTrials.gov Identifier: NCT03994289|
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Disability Physical||Behavioral: Motor-assisted cycling Behavioral: FES cycling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effects of Motor-assisted Cycling and Functional Electrical Stimulation Cycling on Postprandial Glucose in Type 2 Diabetic Patients With Activities of Daily Living Disability|
|Actual Study Start Date :||February 20, 2019|
|Actual Primary Completion Date :||November 15, 2019|
|Actual Study Completion Date :||November 15, 2019|
No Intervention: Control
Participants remain seated for 2 hours after the intake of a standardized breakfast.
Experimental: Motor-assisted cycling
Participants will perform 3 bouts of motor-assisted cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast.
Behavioral: Motor-assisted cycling
Participants will perform the motor-assisted cycling exercise using a physical therapy bike (RECK; Betzenweiler, Germany). Participants will perform 3×10-min bouts of motor-assisted cycling at the highest tolerable cadence. Before each bout, participants will perform 1-2 minutes of motor-assisted cycling at 5-10 rpm as a warm-up.
Experimental: FES cycling
Participants will perform 3 bouts of FES cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast.
Behavioral: FES cycling
The testing procedures will be identical to that in the motor-assisted cycling visit except for the exercise type. Participants will wear FES cuffs on the upper and lower legs, bilaterally.
. The FES cycling will be performed on the motor-assisted bike using the wearable FES equipment. The purpose of motor-assisted cycling is to provide constant cadence. The Bioness L300 Plus system (Bioness, Valencia, CA) will be worn on the upper and lower legs to stimulates the quadriceps and dorsiflexors muscles during the motor-driven cycling exercise. An embedded gyroscope of the cuff can detect the motion of the lower leg so that the electrical stimulations will be generated at appropriate timing to activate leg muscles during the cycling exercise.
- Postprandial glucose AUC [ Time Frame: The glucose will be measured using CGM during the 2-hour postprandial period. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994289
|United States, Arizona|
|Brookdale Senior Living Central Chandler|
|Chandler, Arizona, United States, 85224|