A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients

NCT02320513 | Completed

• 1 other identifier: 20141534
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study intended to gather data in order to inform future studies about the role of feedback as an incentive for increasing levels of physical activity which could improve health in hemodialysis patients.

Conditions

End Stage Renal Disease

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• The effect of physical activity feedback on physical activity levels.

  Physical activity level will be measured by the number of steps each subject takes. The number of steps each subject takes will be recorded and reported to those in one of the two groups. The study will evaluate whether a subject will begin to walk more steps once s/he is informed about the number of steps s/he is taking.

  5 weeks

Study Arms (2)

Control Group

Subjects will wear the activity monitoring device to track their activity between dialysis treatments, however, the feedback from the device will not be shared with them.

Other: Wearing activty monitoring device (Fitbit Flex); Device: Fitbit Flex

Feedback Group

The feedback from the activity monitoring device will be shared with subjects at each visit.

Other: Wearing activty monitoring device (Fitbit Flex); Device: Fitbit Flex

Interventions

Wearing activty monitoring device (Fitbit Flex) OTHER

Control Group; Feedback Group

Fitbit Flex DEVICE

Control Group; Feedback Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Receiving hemodialysis three times a week * On hemodialysis for more than 3 months * Between the ages of 18 and 75 years * Able to walk without assistance or assistive devices * Able to read and understand the English language

You may qualify if:

• Receiving hemodialysis three times a week
• On hemodialysis for more than 3 months
• Between the ages of 18 and 75 years
• Able to walk without assistance or assistive devices
• Able to read and understand the English language

You may not qualify if:

• Patient already uses an activity tracker
• Unstable health: acute infections, congestive heart failure NYHA class 4 and/or unstable angina
• Hospitalization within the past 3 months for non-access related reasons
• Known allergies to nickel
• Unable to physically grip the handheld dynamometer in order to complete the Hand Grip Strength Test
• Cognitive impairment

Sponsors & Collaborators

• Renal Research Institute: lead

Study Sites (1)

Avantua Upper East Side Dialysis Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Peter Kotanko, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: December 19, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (1)