CardiovascularNCT04216238
Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
An observational study of Cardiovascular, run by Methodist Health System at 1 site in United States.
Trial summary
Early mobility in the post cardiovascular surgical patient can dramatically impact patient outcomes. Utilizing an innovative strategy, like a wearable activity monitor, can potentially provide: accurate data on post-operative mobility level; increased motivation and self-efficacy in the recovering patient; data to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular
- What is being tested?
- quasi-experimental Pre-test/Post-test design
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 24 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiovascular surgical patients will be recruited preoperatively for participation in study with an anticipated three month time commitment. Upon informed consent, participant will receive pre-test and wearable activity monitor hardware from study investigator. The 6 minute walk test will be conducted prior to discharge from the hospital and again during the three month follow-up visit along with the post-test survey.
Who may be able to join
- Patient must be at least 18 years old
- Patient must have cardiovascular surgery
- Patient must be able to ambulate without the use of an assistive device
- Patient must be able to wear activity wrist device
- Patient must speak and read English
Who cannot join
- Patient does not speak or read English
- Patient is not able to ambulate, is wheelchair bound, bed bound, or requires the use of an assistive device for ambulation
- Patient is discharged to an inpatient rehabilitation facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Mansfield Medical Center
Mansfield, Texas, 76063
About this study
Early mobility in the post cardiovascular surgical patient can dramatically impact patient outcomes. Utilizing an innovative strategy, like a wearable activity monitor, can potentially provide: accurate data on post-operative mobility level; increased motivation and self-efficacy in the recovering patient; data to potentially drive post-operative mobility goal setting. Use of a wearable activity monitor will reduce time needed to return to pre-operative activity level in the cardiovascular surgical patient.
Read the detailed description
While this study used participants from a general surgical floor, its merit should be translatable to the cardiovascular surgical patient population. Additionally, Thorup et al. (2016) proved a positive correlation between the amount of time a step counting device was worn and the distance walked by patients.
It is no surprise that the importance of activity level and ambulation goals are stressed as much, if not more, to cardiac surgery patients versus other surgical patients. In order to be released from the hospital, a cardiac surgery patient must meet and exceed a certain walking distance. Because of this, much of the post-operative teaching is related to the importance of ambulating, setting distance goals, and defining a walking plan to adhere to during the hospital stay and after discharge.
Early and sustained mobility in the post cardiovascular surgical patient can positively impact patient outcomes. In order to drive these outcomes, patient ownership, motivation and self-accountability beyond the walls of the hospital must be achieved.
This study will use best practice guidelines, the relationship-based care model, and innovative technology to determine if using wearable activity monitors impacts: (1) intrinsic motivation, (2) time of return to pre-operative mobility levels, (3) LOS and readmission rates, and (4) overall fitness level.
The aim of this study is to determine if use of a wearable activity monitor will motivate post cardiovascular surgical patients to increase activity levels over a 12 week period, to determine the wearable activity monitor's ability to influence return to pre-surgical self-reported mobility level, to determine if using a wearable activity monitor will increase 6 minute walk test(6MWT) distance comparing pre-discharge 6MWT and 3 month post 6MWT, to determine amicability of a wearable activity monitor as an intervention strategy in post cardiovascular surgical patients, to determine if use of a wearable activity monitor as a post-operative intervention will impact patient length of stay and/or readmission.
- Conditions
- Cardiovascular
- Being tested
- quasi-experimental Pre-test/Post-test design
- Keywords
- cardiovascular surgical patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quasi-experimental Pre-test/Post-test designBehavioural
surveys to document progress
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular surgical patients | Patients who received cardiovascular surgery and was released from the hospital due to meeting and exceeding a certain walking distance. Receives: Behavioral: quasi-experimental Pre-test/Post-test design |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrinsic motivation
refers to behavior that is driven by internal rewards. In other words, the motivation to engage in a behavior arises from within the individual because it is naturally satisfying.
Measured: over a period of 12 months
time of return to pre-operative mobility levels
time of return to pre-operative mobility levels
Measured: over a period of 12 months
LOS
LENGTH OF STAY
Measured: over a period of 12 months
readmission rates
readmission rates
Measured: over a period of 12 months
overall fitness level
FITNESS LEVEL
Measured: over a period of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start13 Aug 2019
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brooks Williams, BSN, RN, Principal investigator, Methodist Mansfield Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216238
- Sponsor's protocol ID
- 038.NUR.2019.M
- Status last verified
- Feb 2023
- First submitted
- 12 Aug 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Wearable Activity Monitors With Post-Operative Activity Level Among Cardiovascular Surgical Patients
- ClinicalTrials.gov ID
- NCT04216238
- Acronym / sponsor ID
- 038.NUR.2019.M
- Conditions
- Cardiovascular
- Keywords
- cardiovascular surgical patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 2 Jan 2020 (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.
Early mobility in the post cardiovascular surgical patient can dramatically impact patient outcomes. Utilizing an innovative strategy, like a wearable activity monitor, can potentially provide: accurate data on post-operative mobility level; increased motivation and self-efficacy in the recovering patient; data to potentially drive post-operative mobility goal setting. Use of a wearable activity monitor will reduce time needed to return to pre-operative activity level in the cardiovascular surgical patient.
Detailed description
While this study used participants from a general surgical floor, its merit should be translatable to the cardiovascular surgical patient population. Additionally, Thorup et al. (2016) proved a positive correlation between the amount of time a step counting device was worn and the distance walked by patients.
It is no surprise that the importance of activity level and ambulation goals are stressed as much, if not more, to cardiac surgery patients versus other surgical patients. In order to be released from the hospital, a cardiac surgery patient must meet and exceed a certain walking distance. Because of this, much of the post-operative teaching is related to the importance of ambulating, setting distance goals, and defining a walking plan to adhere to during the hospital stay and after discharge.
Early and sustained mobility in the post cardiovascular surgical patient can positively impact patient outcomes. In order to drive these outcomes, patient ownership, motivation and self-accountability beyond the walls of the hospital must be achieved.
This study will use best practice guidelines, the relationship-based care model, and innovative technology to determine if using wearable activity monitors impacts: (1) intrinsic motivation, (2) time of return to pre-operative mobility levels, (3) LOS and readmission rates, and (4) overall fitness level.
The aim of this study is to determine if use of a wearable activity monitor will motivate post cardiovascular surgical patients to increase activity levels over a 12 week period, to determine the wearable activity monitor's ability to influence return to pre-surgical self-reported mobility level, to determine if using a wearable activity monitor will increase 6 minute walk test(6MWT) distance comparing pre-discharge 6MWT and 3 month post 6MWT, to determine amicability of a wearable activity monitor as an intervention strategy in post cardiovascular surgical patients, to determine if use of a wearable activity monitor as a post-operative intervention will impact patient length of stay and/or readmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular surgical patients | – | Behavioral: quasi-experimental Pre-test/Post-test designPatients who received cardiovascular surgery and was released from the hospital due to meeting and exceeding a certain walking distance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular surgical patients will be recruited preoperatively for participation in study with an anticipated three month time commitment. Upon informed consent, participant will receive pre-test and wearable activity monitor hardware from study investigator. The 6 minute walk test will be conducted prior to discharge from the hospital and again during the three month follow-up visit along with the post-test survey.
Key inclusion criteria (5 listed)
- Patient must be at least 18 years old
- Patient must have cardiovascular surgery
- Patient must be able to ambulate without the use of an assistive device
- Patient must be able to wear activity wrist device
- Patient must speak and read English
Key exclusion criteria (3 listed)
- Patient does not speak or read English
- Patient is not able to ambulate, is wheelchair bound, bed bound, or requires the use of an assistive device for ambulation
- Patient is discharged to an inpatient rehabilitation facility
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 |
|---|---|---|
| quasi-experimental Pre-test/Post-test designsurveys to document progress | Behavioural | Cardiovascular surgical patients |
Primary outcome
intrinsic motivation
Time frame: over a period of 12 months
refers to behavior that is driven by internal rewards. In other words, the motivation to engage in a behavior arises from within the individual because it is naturally satisfying.
time of return to pre-operative mobility levels
Time frame: over a period of 12 months
time of return to pre-operative mobility levels
LOS
Time frame: over a period of 12 months
LENGTH OF STAY
readmission rates
Time frame: over a period of 12 months
readmission rates
overall fitness level
Time frame: over a period of 12 months
FITNESS LEVEL
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 23 Mar 2026.
- 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.
Brooks Williams, BSN, RN principal investigator
Methodist Mansfield Medical Center
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 Cardiovascular, run by Methodist Health System 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 3 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 23 Mar 2026. 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?
intrinsic motivation (time frame: over a period of 12 months). The study lists 5 primary outcomes in all. 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 23 Mar 2026.