Cadence and Intensity in Adults With Type 2 Diabetes

Status unconfirmed

Conditions studied: Type 2 Diabetes Mellitus, Walking

In brief

The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate intensity, vigorous-intensity) in adults (40- 65 years-old) with type 2 diabetes.

Key facts

Study ID

NCT03940937

Run by

University of Massachusetts, Amherst

People needed

20

Starts

2019-05-01

Expected to finish

2019-10-01

Last updated by the study team

2019-05-07

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to ambulate on a treadmill (self-reported)
• Diagnosed with type 2 diabetes (self-reported)
• Self-report participating in less than 30 minutes of moderate intensity exercise per day for most days of the week
• Able to fast for at least 4 hours prior to study visit involving the treadmill protocol
• Self-report having an HbA1c measure greater than 7% in the past 6 months

You may not qualify if…

• BMI - <18.5kg/m² or >40kg/m²
• Tobacco use - Currently a smoker or have smoked tobacco within the past 6 months.
• Insulin - Those with type 2 diabetes being controlled with insulin
• Ambulatory ability - Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded. This criterion is similar to that used by NHANES when selecting individuals (up to 85 years of age) to wear motion sensors.
• Resting Blood Pressure - Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99mmHg
• Abnormal resting ECG (evaluated by physician) will be advised to see personal physician (participant provided with resting ECG results)
• Any condition/medication that may affect heart rate response to exercise testing.
• Current participation in any other study protocol which involves taking an experimental medication
• Hospitalization for mental illness within the past 5 years.
• Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks (TIAs), chest pain, unusual dyspnea during physical activity/ exercise, severe ankle edema, or intermittent claudication.
• Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
• Participant experiences dizziness or balance impairment at rest or with exercise
• Participant is currently treated for kidney disease with dialysis, or has severe liver damage? (e.g., liver cirrhosis)
• Participant has a pacemaker or other implanted medical device (including metal joint replacements).
• Participant has chronic lung problems that make it difficult to breathe (e.g., Chronic Respiratory Diseases, Cystic Fibrosis, chronic obstructive pulmonary disease [COPD] or uses supplemental O2)
• Participant has Cancer treated with chemotherapy that affects breathing or heart rate
• Participant experiences shortness or breath at rest or during mild exertion
• Participant is pregnant.
• Participant is unable to complete all testing within a maximal two-week period
• Individuals wearing a full beard may need to be excluded from the study, as large amounts of facial hair around the mouth and nose interfere with the seal of the device that measures the air being breathed. Because of this we are seeking participants that are clean shaven or with a beard where areas around the nose and mouth are clean shaven (e.g. goatee).
• Any significant medical condition that may interfere with the study.

Where it is running

• Totman Building — Amherst, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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