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

NCT ID: NCT03994289

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2019-11-15

Brief 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.

Conditions

Type2 Diabetes; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Motor-assisted cycling

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

Group Type: EXPERIMENTAL

Motor-assisted cycling

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

FES cycling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Chong Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brookdale Senior Living Central Chandler

Chandler, Arizona, United States

Countries

United States

Other Identifiers

STUDY00008262

Identifier Type: -

Identifier Source: org_study_id