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

NCT03994289 | Completed

• 1 other identifier: STUDY00008262
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

exercise; FES

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose AUC

  The glucose will be measured using CGM during the 2-hour postprandial period.

Study Arms (3)

Control

NO INTERVENTION

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

Motor-assisted cycling

EXPERIMENTAL

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

FES cycling

EXPERIMENTAL

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

Behavioral: FES cycling

Interventions

Motor-assisted cycling 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.

Motor-assisted cycling

FES cycling 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.

FES cycling

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 60 years.
• Physician-diagnosed type 2 diabetes.
• ADL disability (self-reported).

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Brookdale Senior Living Central Chandler

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: February 20, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)