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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994289
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Lee, 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Disability Physical Behavioral: Motor-assisted cycling Behavioral: FES cycling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Postprandial glucose AUC [ Time Frame: The glucose will be measured using CGM during the 2-hour postprandial period. ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994289


Locations
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United States, Arizona
Brookdale Senior Living Central Chandler
Chandler, Arizona, United States, 85224
Sponsors and Collaborators
Arizona State University
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Responsible Party: Chong Lee, Associate Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03994289    
Other Study ID Numbers: STUDY00008262
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Lee, Arizona State University:
exercise
FES