End Stage Renal DiseaseIAMNCT02320513
A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients
An observational study of End Stage Renal Disease, run by Renal Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Wearing activty monitoring device (Fitbit Flex) and Fitbit Flex
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Avantua Upper East Side Dialysis Center
New York, New York, 10065
About this study
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.
Read the detailed description
In prior studies that have analyzed physical activity in dialysis patients, three-dimensional accelerometers, physical performance tasks or self-reporting physical activity questionnaires have been used to measure levels of activity. This proposed study differs in that it will determine the effectiveness of providing "feedback" to dialysis patients using a fitness tracking bracelet. For the purpose of this study, the word 'feedback' is used to refer to the information provided to the subject that demonstrates the number of steps taken since the previous dialysis session as displayed by the Fitbit® application. This 'feedback' will allow subjects to be more aware of their overall physical activity on a quantitative level.
The study will seek to explore an association between feedback and physical activity. Improved physical activity could improve indicators of subjects' health status such as blood pressure, inflammatory markers, and pre-albumin levels, which will also be monitored and recorded.
While informing subjects quantitatively about their levels of physical activity could be a promising method to encourage them to be more active, it is unclear at this point if that strategy actually works. This is an important practical question though, because actually informing subjects on a regular basis about their activity level may pose substantial operative challenges and result in additional costs.
The importance of encouraging subjects to be more physically active should not be underestimated. Studying the physical activity of dialysis patients is important because it allows researchers to consider the long-term effects that may influence the subject's well-being. Johansen et al. showed that there was a direct relationship between the inactivity of dialysis patients and susceptibility to hypertension, diabetes, cardiovascular disease and even mortality. Additionally, the study demonstrated the importance of implementing programs to promote physical activity [1]. If feedback does indeed increase physical activity, then it will be substantially beneficial for this program to be implemented.
- Conditions
- End Stage Renal Disease
- Being tested
- Wearing activty monitoring device (Fitbit Flex), Fitbit Flex
- Keywords
- Exercise
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing activty monitoring device (Fitbit Flex)Other
Fitbit FlexDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Wearing activty monitoring device (Fitbit Flex); Device: Fitbit Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320513
- Sponsor's protocol ID
- 20141534
- Acronym
- IAM
- Status last verified
- Sep 2015
- First submitted
- 3 Nov 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02320513
- Acronym / sponsor ID
- IAM / 20141534
- Conditions
- End Stage Renal Disease
- Keywords
- Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In prior studies that have analyzed physical activity in dialysis patients, three-dimensional accelerometers, physical performance tasks or self-reporting physical activity questionnaires have been used to measure levels of activity. This proposed study differs in that it will determine the effectiveness of providing "feedback" to dialysis patients using a fitness tracking bracelet. For the purpose of this study, the word 'feedback' is used to refer to the information provided to the subject that demonstrates the number of steps taken since the previous dialysis session as displayed by the Fitbit® application. This 'feedback' will allow subjects to be more aware of their overall physical activity on a quantitative level.
The study will seek to explore an association between feedback and physical activity. Improved physical activity could improve indicators of subjects' health status such as blood pressure, inflammatory markers, and pre-albumin levels, which will also be monitored and recorded.
While informing subjects quantitatively about their levels of physical activity could be a promising method to encourage them to be more active, it is unclear at this point if that strategy actually works. This is an important practical question though, because actually informing subjects on a regular basis about their activity level may pose substantial operative challenges and result in additional costs.
The importance of encouraging subjects to be more physically active should not be underestimated. Studying the physical activity of dialysis patients is important because it allows researchers to consider the long-term effects that may influence the subject's well-being. Johansen et al. showed that there was a direct relationship between the inactivity of dialysis patients and susceptibility to hypertension, diabetes, cardiovascular disease and even mortality. Additionally, the study demonstrated the importance of implementing programs to promote physical activity [1]. If feedback does indeed increase physical activity, then it will be substantially beneficial for this program to be implemented.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Wearing activty monitoring device (Fitbit Flex), Device: Fitbit FlexSubjects 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. |
| Feedback Group | – | Other: Wearing activty monitoring device (Fitbit Flex), Device: Fitbit FlexThe feedback from the activity monitoring device will be shared with subjects at each visit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing activty monitoring device (Fitbit Flex) | Other | Control Group, Feedback Group |
| Fitbit Flex | Device | Control Group, Feedback Group |
Primary outcome
The effect of physical activity feedback on physical activity levels.
Time frame: 5 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kotanko, MD principal investigator
Renal Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Renal Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of physical activity feedback on physical activity levels. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.