Motor-assisted Cycling and FES Cycling for Postprandial Glucose in Diabetic Patients With ADL Disability

Study Overview
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Brief Summary
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Exercise has been the cornerstone of diabetes management. However, many diabetic patients have ADL disabilities and experience substantial difficulty in performing usual exercises, such as brisk walking and upright cycling. There is an urgent need to provide alternative exercise modalities for diabetic patients with ADL disabilities. In this study, investigators will investigate the effects on the glucose of three exercise modalities, including motor-assisted cycling (i.e., cycling on a motor-driven bike) and functional electrical stimulation (FES) cycling, during which the investigators will use electrical current to facilitate cycling movements.

Official Title
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Effects of Motor-assisted Cycling and Functional Electrical Stimulation Cycling on Postprandial Glucose in Type 2 Diabetic Patients With Activities of Daily Living Disability

Conditions
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Type2 Diabetes, Disability Physical

Intervention / Treatment
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* Behavioral: Motor-assisted cycling
* Behavioral: FES cycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 60 years. Physician-diagnosed type 2 diabetes. ADL disability (self-reported). Exclusion Criteria: Fasting glucose ≥ 250 mg/dL. Symptomatic hypoglycemic events in the past three months. Insulin injection or infusion Systolic blood pressure ≥ 160 mmHg OR Diastolic blood pressure ≥ 100 mmHg Diagnosis of NYHA class I-IV heart failure Myocardial infarction in the past 6 months Recent or current angina, shortness of breath, or other symptoms suggestive of heart failure Diagnosed Cancer Unable to consent due to impaired cognitive function Bone fracture, joint dislocation, or joint stiffness Local skin disorders at the FES cuff area or CGM sensor area Implantable electronic or metallic devices, such as cardioverter defibrillator and pacemaker

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants remain seated for 2 hours after the intake of a standardized breakfast. | |
| Experimental: Motor-assisted cycling<br>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<br>* 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.<br>|
| Experimental: FES cycling<br>Participants will perform 3 bouts of FES cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast. | Behavioral: FES cycling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose AUC |  | The glucose will be measured using CGM during the 2-hour postprandial period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, FES