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

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994289
• Other study ID #: STUDY00008262
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: November 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Type2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brookdale Senior Living Central Chandler	Chandler	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose AUC		The glucose will be measured using CGM during the 2-hour postprandial period.