Physical ActivityNCT05241171
The "Step4Life" Randomized Control Trial in Hemodialysis
A study testing Fitbit in people with Physical Activity and End Stage Kidney Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
Persons with end-stage kidney disease (ESKD) have very low physical activity, and among ESKD patients, the level of inactivity is strongly associated with morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, End Stage Kidney Disease, Hemodialysis
- What is being tested?
- Fitbit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 30 May 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,
Who cannot join
- 1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92101
About this study
Official title: The Impact of Use of a Wearable Pedometer and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The "Step4Life" Randomized Control Trial
Persons with end-stage kidney disease (ESKD) have very low physical activity, and among ESKD patients, the level of inactivity is strongly associated with morbidity and mortality. This study aimed to assess the feasibility and effectiveness of a 12-week intervention coupling use of wearable pedometers (FitBit ®) and feedback coaching to increase physical activity in hemodialysis patients.
Read the detailed description
Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.
There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.
We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.
- Conditions
- Physical Activity, End Stage Kidney Disease, Hemodialysis
- Being tested
- Fitbit
- Medical subject headings
- Motor Activity, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit plus Feedback Intervention | Experimental | Participants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts, Receives: Device: Fitbit |
| Fitbit alone | Active comparator | Participants in self-managed control group were provided access to the Fitbit website or app but did not receive any feedback on their activity level from the study team. Receives: Device: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
the absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups.
weekly step counts measured with Fitbit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2019
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Malhotra, University of California, San Diego
- Investigators
- Rakesh Malhotra, MD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241171
- Sponsor's protocol ID
- P171917
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Malhotra R, Rahimi S, Agarwal U, Katz R, Kumar U, Garimella PS, Gupta V, Chopra T, Kotanko P, Ikizler TA, Larsen B, Cadmus-Bertram L, Ix JH. The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. Am J Kidney Dis. 2023 Jul;82(1):75-83. doi: 10.1053/j.ajkd.2022.12.011. Epub 2023 Feb 17.
PubMed 36801430
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Use of a Wearable Pedometer and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The "Step4Life" Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05241171
- Acronym / sponsor ID
- P171917
- Conditions
- Physical Activity, End Stage Kidney Disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 15 Feb 2022 (actual)
- 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.
Persons with end-stage kidney disease (ESKD) have very low physical activity, and among ESKD patients, the level of inactivity is strongly associated with morbidity and mortality. This study aimed to assess the feasibility and effectiveness of a 12-week intervention coupling use of wearable pedometers (FitBit ®) and feedback coaching to increase physical activity in hemodialysis patients.
Detailed description
Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.
There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.
We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit plus Feedback Intervention | Experimental | Device: FitbitParticipants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts, |
| Fitbit alone | Active comparator | Device: FitbitParticipants in self-managed control group were provided access to the Fitbit website or app but did not receive any feedback on their activity level from the study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,
Key exclusion criteria (1 listed)
- 1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
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 |
|---|---|---|
| FitbitThe study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization. | Device | Fitbit alone, Fitbit plus Feedback Intervention |
Primary outcome
the absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups.
Time frame: 12 weeks
weekly step counts measured with Fitbit
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 15 Feb 2022.
- Derived from this study: PubMed 36801430Malhotra R, Rahimi S, Agarwal U, Katz R, Kumar U, Garimella PS, Gupta V, Chopra T, Kotanko P, Ikizler TA, Larsen B, Cadmus-Bertram L, Ix JH. The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. Am J Kidney Dis. 2023 Jul;82(1):75-83. doi: 10.1053/j.ajkd.2022.12.011. Epub 2023 Feb 17.
- Individual participant dataSharing planned: Undecided
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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.
Rakesh Malhotra, MD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit in people with Physical Activity and End Stage Kidney Disease, run by University of California, San Diego 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 1 inclusion and 1 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 15 Feb 2022. 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 absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241171, which also lists 1 linked publication.
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 15 Feb 2022.