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Leisure Expectations About Physical Activity Study
LEAP
Establishing Appropriate Activity Expectations After Total Joint Replacement
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To pilot test an activity-focused intervention that educates patients undergoing total hip (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type, frequency, intensity, and duration of expected leisure activities after surgery and to determine if the intervention changed expectations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2018
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
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2019
CompletedJuly 24, 2019
July 1, 2019
11 months
February 12, 2013
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention.
The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention
One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
Secondary Outcomes (2)
Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.
One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months
Baseline (approximately 3-4 weeks before surgery)
Study Arms (2)
Educational intervention
EXPERIMENTALPatients in this group will receive a brief educational intervention to assist them in setting the appropriate expectations for leisure activity after surgery with respect to the type, amount, intensity, and duration of activity.
Control group
NO INTERVENTIONNo intervention will be received. Patients will receive a written version of the education intervention at the end of the study.
Interventions
A 30-minute discussion and slide presentation with a trained member of the research team.
Eligibility Criteria
You may qualify if:
- The study includes male or female patients, aged 45 years and older who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis.
You may not qualify if:
- Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dina L. Jones, PT, PhD
West Virginia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2013
First Posted
September 10, 2013
Study Start
January 1, 2018
Primary Completion
December 1, 2018
Study Completion
July 22, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share