NCT02075931

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

February 26, 2014

Last Update Submit

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

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.

Other: Physical activity feedback with group meetings

Control

ACTIVE COMPARATOR

The control represents the current standard of care post total knee arthroplasty.

Other: Control

Interventions

Physical activity feedback

Physical Activity Feedback
ControlOTHER

No intervention

Control

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jennifer Stevens-Lapsley, MPT, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

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

Locations