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Cadence and Intensity Across the Adult Lifespan (CADENCE-Adults)

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: NCT02650258
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Amherst

Brief Summary:
The purpose of this study is to determine and link cadence (the number of steps taken in a minute) to the intensity of physical activity (e.g. low-, moderate- and vigorous-intensity) in adults (21-85 years old). The investigators anticipate that cadence will be a good indicator of exercise intensity. Identifying how cadence relates to activity intensity will allow for physical activity guidelines to be communicated to the public in a manner that is more accessible to the lay person.

Condition or disease Intervention/treatment
Aging Walking Motor Activity Activities of Daily Living Behavioral: treadmill walking

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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cadence and Intensity Across the Adult Lifespan
Study Start Date : December 2015
Actual Primary Completion Date : August 5, 2019
Actual Study Completion Date : August 5, 2019

Group/Cohort Intervention/treatment
Young Adult
80 Adults 21-40 years of age: 10 Male and 10 Female in each 5 year increment (21-25, 26-30, 31-35, 36-40).
Behavioral: treadmill walking
all participants walking at increasing speeds on a treadmill

Middle Aged Adults
80 Adults 41-60 years of age: 10 Male and 10 Female in each 5 year increment (41-45, 46-50, 51-55, 56-60).
Behavioral: treadmill walking
all participants walking at increasing speeds on a treadmill

Older Adults
100 Adults 61-85 years of age: 10 Male and 10 Female in each 5 year increment (61-65, 66-69, 70-75, 76-80, 81-85).
Behavioral: treadmill walking
all participants walking at increasing speeds on a treadmill




Primary Outcome Measures :
  1. Cadence (steps/min) as assessed by observation (hand tallied counts) of cadence [ Time Frame: Cross-sectional data; single time point, throughout study, up to 5 years ]
    The identification of cadence value cut-points associated with low, moderate and vigorous activity.

  2. Monitor validation (difference in steps/min compared to observation/hand tallied counts) [ Time Frame: Cross-sectional data; single time point, throughout study, up to 5 years ]
    Compare the ability of different activity monitors to accurately measure cadence



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample from the surrounding community of male and females 21-85 years will be recruited as participants. Specifically, 10 men and 10 women for each 5-year age-group category (21-25, 26-30, 31-35, etc.) will be collected.
Criteria

Inclusion Criteria:

  • Adults between ages 21-85 years, able to ambulate on a treadmill (self-report)

Exclusion Criteria:

  • BMI less than 18.5 or more than 40kg/m^2
  • Having smoked tobacco within the past 6 months
  • wheelchair bound, or conditions that prevent normal ambulation
  • Resting systolic blood pressure > 159 mm HG, or diastolic blood pressure > 99 mm HG
  • Hospitalization for mental illness within the past 5 years (for the 41-60 and 61-85 year old cohorts this was change to "within the past 1 year").
  • Any condition/medication that may affect heart rate response to exercise testing.
  • Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle swelling, or leg pain while walking.
  • Any significant medical condition that may interfere with the study.
  • Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
  • Participant has a pacemaker or other implanted medical device (including metal joint replacements).
  • Participant is pregnant.
  • Participant is unable to complete all testing (1 or two sessions, based on risk factors) 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 you breath. 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).

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): NCT02650258


Locations
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United States, North Carolina
Walking Research Laboratory, University of North Carolina at Charlotte
Charlotte, North Carolina, United States, 28223
Sponsors and Collaborators
University of Massachusetts, Amherst
Investigators
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Principal Investigator: Catrine Tudor-Locke, PhD University of North Carolina at Charlotte
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT02650258    
Other Study ID Numbers: 1R01AG049024 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests for de-identified individual-level data (including descriptors) collected in CADENCE-Adults and used in publications will be considered and made available to qualified researchers within 2 years of publication of the associated paper. Data sharing agreements will be necessary for access.The CADENCE-Adults data base will be maintained and access ensured by the Physical Activity and Health Laboratory in the Department of Kinesiology at University of Massachusetts Amherst.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Researchers can request supporting information for two years post-publication
Access Criteria: Contact PI