Cadence and Intensity in Adults With Type 2 Diabetes
CADENCE-T2DM
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedMay 7, 2019
May 1, 2019
5 months
September 11, 2018
May 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Cadence (steps/min)
Cadence (steps/min) as assessed by direct observation of steps (hand-tallied counts) divided by time
Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour)
Oxygen consumption (VO2; mL/kg/min)
The amount of oxygen consumed, as measured with indirect calorimetry, expressed per unit of body mass
Through completion of the treadmill walking protocol that occurs during the study visit (approximately 1 hour)
Eligibility Criteria
A convenience sample from the surrounding community consisting of twenty 40-65 yr old adults (10 men, 10 women) with pharmacologically-controlled type 2 diabetes (not using insulin). Participants must self-report being non-active (less than 30 minutes of moderate intensity exercise per day for most days of the week) and to have an HbA1c not at goal (therefore \>7%) in the past 6 months.
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)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Totman Building
Amherst, Massachusetts, 01002, United States
Related Publications (2)
Tudor-Locke C, Rowe DA. Using cadence to study free-living ambulatory behaviour. Sports Med. 2012 May 1;42(5):381-98. doi: 10.2165/11599170-000000000-00000.
PMID: 22462794BACKGROUNDCaron N, Peyrot N, Caderby T, Verkindt C, Dalleau G. Energy Expenditure in People with Diabetes Mellitus: A Review. Front Nutr. 2016 Dec 22;3:56. doi: 10.3389/fnut.2016.00056. eCollection 2016.
PMID: 28066773BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart C Chipkin, MD
University of Massachusetts Amherst, Department of Kinesiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
September 11, 2018
First Posted
May 7, 2019
Study Start
May 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share