Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty
1 other identifier
interventional
45
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFebruary 23, 2018
February 1, 2018
4 years
February 26, 2014
February 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Physical activity
Daily step and activity counts
Change from baseline to immediately post-12 week intervention
Secondary Outcomes (2)
Change in Functional performance
Change from baseline to immediately post-12 week intervention
Change in Self-reported physical function
Change from baseline to immediately post-12 week intervention
Study Arms (2)
Physical Activity Feedback
EXPERIMENTALThe 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 COMPARATORThe control represents the current standard of care post total knee arthroplasty.
Interventions
Physical activity feedback
Eligibility Criteria
You may qualify if:
- undergone unilateral total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Stevens-Lapsley, MPT, PhD
Associate Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
March 3, 2014
Study Start
February 1, 2014
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
February 23, 2018
Record last verified: 2018-02