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

Arizona State University (ASU)

Status: Completed

Conditions: Type2 Diabetes; Disability Physical

Treatments: Behavioral: FES cycling; Behavioral: Motor-assisted cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT03994289

STUDY00008262

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9 participants in 3 patient groups

Control

No Intervention group

Description:

Participants remain seated for 2 hours after the intake of a standardized breakfast.

Motor-assisted cycling

Experimental group

Description:

Participants will perform 3 bouts of motor-assisted cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast.

Treatment:

Behavioral: Motor-assisted cycling

FES cycling

Experimental group

Description:

Participants will perform 3 bouts of FES cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast.

Treatment:

Behavioral: FES cycling