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Completed

NCT Number: NCT03994289

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

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Key information

Conditions

Type2 Diabetes Behavior Disability Physical Motor Activity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brookdale Senior Living Central Chandler

Chandler, Arizona, 85224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postprandial glucose AUC

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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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