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

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; Disability Physical
• Intervention / Treatment: Behavioral: Motor-assisted cycling; Behavioral: FES cycling

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Brookdale Senior Living Central Chandler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: exercise; FES
• Other Study ID Numbers: STUDY00008262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No