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

Not Applicable

Completed

• Conditions: Type2 Diabetes; Disability Physical
• Interventions: Behavioral: Motor-assisted cycling; Behavioral: FES cycling

• Registration Number: NCT03994289
• Lead Sponsor: Arizona State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postprandial glucose AUC	The glucose will be measured using CGM during the 2-hour postprandial period.

Trial Locations

Locations (1)

Brookdale Senior Living Central Chandler; 🇺🇸 Chandler, Arizona, United States