OsteoarthritisNCT02075931
Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty
A study testing Physical activity feedback with group meetings in people with Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators have learned that knee replacement patients are not more physically active after surgery. This is true even though their pain is less compared to before surgery. This low level of physical activity is not healthy. It can increase the chances of weight gain, which can create other issues. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Physical activity feedback with group meetings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2018
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergone unilateral total knee arthroplasty
Who cannot join
- severe contralateral leg osteoarthritis (>4/10 with stair climbing)
- unstable orthopaedic condition that limits function
- neurological conditions that affect muscle function
- vascular or cardiac conditions that limit function
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
The investigators have learned that knee replacement patients are not more physically active after surgery. This is true even though their pain is less compared to before surgery. This low level of physical activity is not healthy. It can increase the chances of weight gain, which can create other issues. It can also lessen physical function. Some studies have looked at physical activity feedback systems to increase how active people are. Studies have investigated face to face patient group meetings for this,too. These systems and meetings can increase physical activity. The investigators will study the effects of a physical activity monitors with group meetings after knee replacement. The investigators hypothesize that physical activity levels and physical function will increase. The investigators goal is to help knee replacement patients lead healthier lives and maintain or enhance their physical function.
Read the detailed description
More than 650,000 total knee arthroplasties (TKAs) are performed annually to alleviate pain and disability associated with osteoarthritis (OA); a chronic, degenerative condition that compromises the quality of life of 37% of adults over age 60. With the aging of the population, an estimated 3.5 million TKAs will be performed annually by 2030. Despite improvements in pain and self-reported function, physical activity after TKA remains at pre-operative, sedentary levels (<5,000 steps/day). Physical activity in TKA confers powerful protective effects against common post-surgical sequelae including increased weight gain (mean=6.4 kg, 2 years post TKA), decreased functional performance, increased risk/progression of co-morbid conditions (e.g. type 2 diabetes mellitus, cardiovascular disease), and progression of knee and hip osteoarthritis which may necessitate additional joint replacement in the contralateral limb. An intervention aimed at improved self-management of physical activity may aid patients in overcoming habitual lifestyle patterns of low physical activity secondary to knee pain prior to TKA.
Recent investigations on the effects of real-time, user-friendly, electronic physical activity feedback (PAF) systems and face-to-face (FTF) patient group meetings aimed to promote self-management of physical activity suggest that such interventions can successfully increase physical activity. Therefore, the investigators propose a randomized, controlled trial to assess efficacy and feasibility of a physical activity intervention combined with FTF group meetings (PAF+FTF) initiated within one month of patients' discharge from outpatient rehabilitation for TKA compared to a control group receiving standard care (CON). This type of intervention is surprisingly novel to this patient population and is not common practice in rehabilitation following TKA.
- Conditions
- Osteoarthritis
- Being tested
- Physical activity feedback with group meetings, Control
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity feedback with group meetingsOther
Physical activity feedback
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Feedback | Experimental | The physical activity feedback intervention will involve real-time physical activity monitoring using a device to provide activity feedback directly to patients in combination with patient group meetings held monthly during the 12 week intervention for the purposes of mutual support in attaining physical activity goals. Receives: Other: Physical activity feedback with group meetings |
| Control | Active comparator | The control represents the current standard of care post total knee arthroplasty. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity
Daily step and activity counts
Measured: Change from baseline to immediately post-12 week intervention
Secondary outcomes (2)
Change in Functional performance
Six-minute walk test, timed up-and-go, 10 meter walk test
Measured: Change from baseline to immediately post-12 week intervention
Change in Self-reported physical function
Knee injury and Osteoarthritis Outcome Score, Physical Activity Scale for the Elderly
Measured: Change from baseline to immediately post-12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, MPT, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075931
- Sponsor's protocol ID
- 13-2568
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2014
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02075931
- Acronym / sponsor ID
- 13-2568
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 3 Mar 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.
The investigators have learned that knee replacement patients are not more physically active after surgery. This is true even though their pain is less compared to before surgery. This low level of physical activity is not healthy. It can increase the chances of weight gain, which can create other issues. It can also lessen physical function. Some studies have looked at physical activity feedback systems to increase how active people are. Studies have investigated face to face patient group meetings for this,too. These systems and meetings can increase physical activity. The investigators will study the effects of a physical activity monitors with group meetings after knee replacement. The investigators hypothesize that physical activity levels and physical function will increase. The investigators goal is to help knee replacement patients lead healthier lives and maintain or enhance their physical function.
Detailed description
More than 650,000 total knee arthroplasties (TKAs) are performed annually to alleviate pain and disability associated with osteoarthritis (OA); a chronic, degenerative condition that compromises the quality of life of 37% of adults over age 60. With the aging of the population, an estimated 3.5 million TKAs will be performed annually by 2030. Despite improvements in pain and self-reported function, physical activity after TKA remains at pre-operative, sedentary levels (<5,000 steps/day). Physical activity in TKA confers powerful protective effects against common post-surgical sequelae including increased weight gain (mean=6.4 kg, 2 years post TKA), decreased functional performance, increased risk/progression of co-morbid conditions (e.g. type 2 diabetes mellitus, cardiovascular disease), and progression of knee and hip osteoarthritis which may necessitate additional joint replacement in the contralateral limb. An intervention aimed at improved self-management of physical activity may aid patients in overcoming habitual lifestyle patterns of low physical activity secondary to knee pain prior to TKA.
Recent investigations on the effects of real-time, user-friendly, electronic physical activity feedback (PAF) systems and face-to-face (FTF) patient group meetings aimed to promote self-management of physical activity suggest that such interventions can successfully increase physical activity. Therefore, the investigators propose a randomized, controlled trial to assess efficacy and feasibility of a physical activity intervention combined with FTF group meetings (PAF+FTF) initiated within one month of patients' discharge from outpatient rehabilitation for TKA compared to a control group receiving standard care (CON). This type of intervention is surprisingly novel to this patient population and is not common practice in rehabilitation following TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Feedback | Experimental | Other: Physical activity feedback with group meetingsThe physical activity feedback intervention will involve real-time physical activity monitoring using a device to provide activity feedback directly to patients in combination with patient group meetings held monthly during the 12 week intervention for the purposes of mutual support in attaining physical activity goals. |
| Control | Active comparator | Other: ControlThe control represents the current standard of care post total knee arthroplasty. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergone unilateral total knee arthroplasty
Key exclusion criteria (4 listed)
- severe contralateral leg osteoarthritis (>4/10 with stair climbing)
- unstable orthopaedic condition that limits function
- neurological conditions that affect muscle function
- vascular or cardiac conditions that limit function
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 |
|---|---|---|
| Physical activity feedback with group meetingsPhysical activity feedback | Other | Physical Activity Feedback |
| ControlNo intervention | Other | Control |
Primary outcome
Change in Physical activity
Time frame: Change from baseline to immediately post-12 week intervention
Daily step and activity counts
2 secondary outcomes
Change in Functional performance
Time frame: Change from baseline to immediately post-12 week intervention
Change in Self-reported physical function
Time frame: Change from baseline to immediately post-12 week intervention
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 Feb 2018.
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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.
Jennifer Stevens-Lapsley, MPT, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity feedback with group meetings in people with Osteoarthritis, run by University of Colorado, Denver 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 4 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 Feb 2018. 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?
Change in Physical activity (time frame: Change from baseline to immediately post-12 week intervention). 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 Feb 2018.