Arthroplasty, Replacement, KneeNCT03037619
Fitbit and Social Support in Knee Replacement Patients & Buddies
A study testing Fitbit and Fitbit+Support in people with Arthroplasty, Replacement, Knee, run by University of South Carolina at 1 site in United States.
Trial summary
Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Fitbit and Fitbit+Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Knee replacement patients must (1) have had a knee replacement in the last 12 months; (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4) willing to wear the Fitbit for 4 months, and (5) have a "buddy" willing to participate.
- Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be English speaking, and (3) willing to wear the Fitbit for 4 months.
Who cannot join
- Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement
Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed among healthy populations. Knee replacement patients often expect their activity levels and function to improve following surgery, but the majority of patients' activity levels 5 years post-operatively did not meet their pre-operative expectations. Even though improvements are observed in pain and function, reasons for the maintenance of low levels of activity are unknown. Technology has the potential to increase physical activity levels in these patients, particularly as 81% of knee replacement patients in our recent study had a smartphone, and 40% were willing to wear a wrist-worn physical activity monitor. As the average age of knee replacement continues to decrease, we anticipate that the percent of patients with a smartphone and willingness to wear an activity monitor will increase. In addition to technology, social support is associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn physical activity monitor and providing additional opportunities for social support via the technology may increase physical activity levels in these patients. The current pilot study aims to gain preliminary data on the influence of wearables and social support on physical activity in knee replacement patients following surgery. Specifically, we aim to recruit 20 patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support. Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4 months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both the participant and "buddy" will be given a Fitbit and they will be asked to friend each other via Fitbit and wear the monitor for 4 months.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Fitbit, Fitbit+Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitBehavioural
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
Fitbit+SupportBehavioural
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit | Experimental | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. Receives: Behavioral: Fitbit |
| Fitbit+Support | Experimental | Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. Receives: Behavioral: Fitbit+Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate/Vigorous Intensity Physical Activity
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Measured: 4 months
Secondary outcomes (3)
Social Support
Social Support \& Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support
Measured: 4 months
Percentage of Participants Satisfied With the Fitbit
Acceptability of the Fitbit (% satisfied with Fitbit)
Measured: 4 months
Fitbit Engagement
Percentage of days Fitbit was worn
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start6 Mar 2017
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037619
- Sponsor's protocol ID
- Pro00063842
- Status last verified
- Sep 2019
- First submitted
- 27 Jan 2017
- Last updated
- 16 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement
- ClinicalTrials.gov ID
- NCT03037619
- Acronym / sponsor ID
- Pro00063842
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed among healthy populations. Knee replacement patients often expect their activity levels and function to improve following surgery, but the majority of patients' activity levels 5 years post-operatively did not meet their pre-operative expectations. Even though improvements are observed in pain and function, reasons for the maintenance of low levels of activity are unknown. Technology has the potential to increase physical activity levels in these patients, particularly as 81% of knee replacement patients in our recent study had a smartphone, and 40% were willing to wear a wrist-worn physical activity monitor. As the average age of knee replacement continues to decrease, we anticipate that the percent of patients with a smartphone and willingness to wear an activity monitor will increase. In addition to technology, social support is associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn physical activity monitor and providing additional opportunities for social support via the technology may increase physical activity levels in these patients. The current pilot study aims to gain preliminary data on the influence of wearables and social support on physical activity in knee replacement patients following surgery. Specifically, we aim to recruit 20 patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support. Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4 months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both the participant and "buddy" will be given a Fitbit and they will be asked to friend each other via Fitbit and wear the monitor for 4 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit | Experimental | Behavioral: FitbitParticipants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. |
| Fitbit+Support | Experimental | Behavioral: Fitbit+SupportParticipants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Knee replacement patients must (1) have had a knee replacement in the last 12 months; (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4) willing to wear the Fitbit for 4 months, and (5) have a "buddy" willing to participate.
- Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be English speaking, and (3) willing to wear the Fitbit for 4 months.
Key exclusion criteria (1 listed)
- Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.
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 |
|---|---|---|
| FitbitParticipants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months | Behavioural | Fitbit |
| Fitbit+SupportParticipants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. | Behavioural | Fitbit+Support |
Primary outcome
Moderate/Vigorous Intensity Physical Activity
Time frame: 4 months
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
3 secondary outcomes
Social Support
Time frame: 4 months
Percentage of Participants Satisfied With the Fitbit
Time frame: 4 months
Fitbit Engagement
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Fitbit+Support in people with Arthroplasty, Replacement, Knee, run by University of South Carolina 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 2 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 16 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Moderate/Vigorous Intensity Physical Activity (time frame: 4 months). 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 16 Sep 2019.