Type2 DiabetesNCT03994289
Motor-assisted Cycling and FES Cycling for Postprandial Glucose in Diabetic Patients With ADL Disability
A study testing Motor-assisted cycling and FES cycling in people with Type2 Diabetes and Disability Physical, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type2 Diabetes, Disability Physical
- What is being tested?
- Motor-assisted cycling and FES cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 60 years.
- Physician-diagnosed type 2 diabetes.
- ADL disability (self-reported).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brookdale Senior Living Central Chandler
Chandler, Arizona, 85224
About this study
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
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
- Being tested
- Motor-assisted cycling, FES cycling
- Keywords
- exercise, FES
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-assisted cyclingBehavioural
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 cyclingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: FES cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose AUC
Measured: The glucose will be measured using CGM during the 2-hour postprandial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start20 Feb 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lee, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994289
- Sponsor's protocol ID
- STUDY00008262
- Status last verified
- Nov 2019
- First submitted
- 19 Jun 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03994289
- Acronym / sponsor ID
- STUDY00008262
- Conditions
- Type2 Diabetes, Disability Physical
- Keywords
- exercise, FES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants remain seated for 2 hours after the intake of a standardized breakfast. |
| Motor-assisted cycling | Experimental | Behavioral: Motor-assisted cyclingParticipants will perform 3 bouts of motor-assisted cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast. |
| FES cycling | Experimental | Behavioral: FES cyclingParticipants will perform 3 bouts of FES cycling, each bout lasting 10 minutes, after the intake of a standardized breakfast. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 60 years.
- Physician-diagnosed type 2 diabetes.
- ADL disability (self-reported).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-assisted cyclingParticipants 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. | Behavioural | Motor-assisted cycling |
| FES cyclingThe 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. | Behavioural | FES cycling |
Primary outcome
Postprandial glucose AUC
Time frame: The glucose will be measured using CGM during the 2-hour postprandial period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-assisted cycling and FES cycling in people with Type2 Diabetes and Disability Physical, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose AUC (time frame: The glucose will be measured using CGM during the 2-hour postprandial period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.