Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2022-11-04
2024-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Immediate Fitbit Intervention
Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention
Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
Comparator: Delayed Fitbit Intervention
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention
Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fitbit Intervention
Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mild-to-moderate physical functional impairment (raw score between 20 and 34 on the 8-item PROMIS Physical Function survey)
* Able to speak, read, \& understand English or Spanish
* Participating in less than 120 minutes per week of moderate-intensity physical activity
* Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker) and without stopping to rest
* Own a smartphone or tablet \*OR\* be willing to use a study-provided smartphone capable of running the Fitbit app. Also, access to the internet or a Wi-Fi hotspot at least once per week is required. Smartphones and data plans will be provided to those individuals who are eligible but do not currently own a device capable of running the Fitbit app.
* Availability of a family member or friend to be present (for safety) during the remote assessment of physical performance tests
* Willingness to be randomized to either study arm and to wear activity trackers
Exclusion Criteria
* Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily light physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, dementia, oxygen dependent, chronic vertigo)
* Paid employment or volunteer position for greater than 20 hours per week (to avoid potential confounding by occupation activity/inactivity)
* Currently participating in a program (personal program, e.g., wearing an activity monitor, or structured program, e.g., another study) to decrease sedentary time or increase physical activity
* Planning to move out of New Mexico within the next year
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of New Mexico
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cindy K Blair, PhD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of New Mexico
Albuquerque, New Mexico, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Blair CK, Brown-Glaberman U, Walters ST, Pestak C, Boyce T, Barriga L, Burgess E, Tawfik B, Killough C, Kinney AY, Demark-Wahnefried W, Meisner AL, Wiggins CL, Pankratz VS, Davis S. A Remotely Delivered Light-Intensity Physical Activity Intervention for Older Cancer Survivors: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e59504. doi: 10.2196/59504.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UNM HSC 17-335
Identifier Type: -
Identifier Source: org_study_id