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Leisure Expectations About Physical Activity Study (LEAP)

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Osteoarthritis focused on measuring Hip, Knee, Osteoarthritis, Arthroplasty, Physical Activity, Expectations, Leisure Activity

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational intervention

Control group

Arm Description

Patients 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.

No intervention will be received. Patients will receive a written version of the education intervention at the end of the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.
The Historical Leisure Activity Questionnaire will be used to determine if patients expect to meet the nationally recommended physical activity levels 6 months after surgery (i.e., 2.5 hours or more of at least moderate-intensity aerobic activity per week in bouts of 10 or more minutes).
Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months
Expected activity at 6 months - baseline activity = expected change in activity

Full Information

First Posted
February 12, 2013
Last Updated
July 22, 2019
Sponsor
West Virginia University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01938274
Brief Title
Leisure Expectations About Physical Activity Study
Acronym
LEAP
Official Title
Establishing Appropriate Activity Expectations After Total Joint Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Enrollment never started
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Consecutive patients, aged 45 years and older, who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis will be randomized to an intervention or control (no intervention) group. All patients will be interviewed by telephone prior to the intervention, by an interviewer blinded to group status, to collect data on current leisure activity and expected activity at 6 months after surgery. Patients will also complete a questionnaire to collect data on sociodemographic characteristics, comorbidities (American Academy of Orthopaedic Surgeons Comorbidity Index), pain intensity (0-10 scale), health-related quality of life (SF-12), hip-/knee-specific outcomes (Hip Dysfunction and Osteoarthritis Outcome Score/Knee Injury and Osteoarthritis Outcome Score), general expectations (Hospital for Special Surgery Total Hip/Knee Replacement Expectations Surveys), and stage of readiness for change. All patients will receive usual medical care before surgery and visit the clinic to meet with the surgeon and nurse/physician assistant, and undergo pre-operative laboratory testing. Patients in the intervention group will also meet with a member of the research team to complete a 10-item pre-test, to assess knowledge of the key concepts in the intervention, and then be presented with a 20-minute slide presentation. The presentation will educate patients on the: 1) definition of physical activity and its associated health benefits for the general population and people with arthritis, (2) 2008 Physical Activity Guidelines for Americans, 3) appropriate types of aerobic activities that patients should engage in after THA/TKA (e.g., no- or low-impact activities), (4) appropriate intensity level for activities after THA/TKA (e.g., at least moderate intensity), (5) appropriate duration of participation in activities (e.g., in increments of 10 or more minutes), and (6) the appropriate amount of activity per week (e.g., ≥ 2.5 hours [150 minutes]). Patients will then complete a satisfaction survey that will provide feedback on the content, format, and length of the intervention, and a post-test to measure mastery of the intervention material. The post-test will contain the same questions as the pre-test, but in a different order. The control group will not meet with the research team during their pre-operative visit. The control group will receive a written version of the intervention at the end of the study. All patients will be re-interviewed by telephone one week after their visit to reassess leisure activity expectations. Data analyses will be conducted to determine: 1) the direction and magnitude of change expected in leisure activity between baseline and 6 months, 2) the change in the proportion of patients who expect to meet national physical activity guidelines 6 month after surgery, and 3) whether or not the intervention modified the type, frequency, duration, or intensity of expected leisure activity from pre- to post-administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis
Keywords
Hip, Knee, Osteoarthritis, Arthroplasty, Physical Activity, Expectations, Leisure Activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be received. Patients will receive a written version of the education intervention at the end of the study.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
A 30-minute discussion and slide presentation with a trained member of the research team.
Primary Outcome Measure Information:
Title
Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention.
Description
The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention
Time Frame
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 Outcome Measure Information:
Title
Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.
Description
The Historical Leisure Activity Questionnaire will be used to determine if patients expect to meet the nationally recommended physical activity levels 6 months after surgery (i.e., 2.5 hours or more of at least moderate-intensity aerobic activity per week in bouts of 10 or more minutes).
Time Frame
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).
Title
Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months
Description
Expected activity at 6 months - baseline activity = expected change in activity
Time Frame
Baseline (approximately 3-4 weeks before surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina L. Jones, PT, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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